MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'federal trade commission'. Sat, 03 Sep 2011 02:31:52 +0100 http://www.medworm.com/index.php?rid=5182322&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSXrWAMrwa34%2F In an effort to thwart generic competition, brand-name drugmakers are promising not to launch so-called authorized generics if their generic rivals promise not to market copycat versions of the brand-name drugs, according to a new report from the US Federal Trade Commission. The findings, released in a 270-page report, explore a twist on the controversial practice of pay-to-delay in which brand-name drugmakers settle patent litigation with an agreement that involves a payment and a commitment by a generic drugmaker not to launch a rival med for a specified period of time. The FTC has called these deals anti-competitive and cost consumers $3.5 billion annually. Now, the agency, which has been urging Congress to pass legislation to restrict these deals (see here), is turning its attention to... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182322 Thu, 01 Sep 2011 12:51:07 +0100 5182322 http://www.medworm.com/index.php?rid=5051240&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ff0rmi8u5dV8%2F The US Senate Judiciary Committee has approved a bipartisan bill that would limit pay-to-delay settlements that are designed to keep lower-cost generic drugs off the market for extended periods. The move comes after the US Supreme Court declined to review one hotly contested deal (see this) amid repeated cries from the US Federal Trade Commission that settlements are anticompetitive and costly to consumers. Under the bill, which is called the Preserve Access to Affordable Generic Drugs Act, brand-name drugmakers would be deterred from settling patent disputes by paying generic rivals in exchange for promises that a copycat version of its drug will be kept off the market. The deals would be considered illegal and the FTC would be given the authority to stop the agreements (read the legislat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5051240 Thu, 21 Jul 2011 20:04:25 +0100 5051240 http://www.medworm.com/index.php?rid=4921757&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC0tblUFA4DY%2F In what some say would be a highly unusual move, the US Federal Trade Commission is considering using its rule-making power to stop pay-to-delay deals between brand-name drugmakers and their generic rivals, after failing to convince Congress or the courts to act, Bloomberg News reports. A rule to block the deals would involve antitrust issues, rather than consumer protection, and could be made on the agency’s own initiative under its basic statutory authority rather than at the direction of Congress, Bert Foer, president of the American Antitrust Institute, tells the news service. “Any potential attempt by the FTC to move forward unilaterally with such a rulemaking would be unprecedented,” Sean Heather, executive director of the global regulatory cooperation project at the US Cha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4921757 Thu, 09 Jun 2011 15:10:23 +0100 4921757 http://www.medworm.com/index.php?rid=4902405&cid=t_169632_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FI8niYC-xAnE%2F By Jim HarperIt might be tempting to laugh at France’s ban on words like “Facebook” and Twitter” in the media. France’s Conseil Supérieur de l’Audiovisuel recently ruled that specific references to these sites (in stories not about them) would violate a 1992 law banning “secret” advertising. The council was created in 1989 to ensure fairness in French audiovisual communications, such as in allocation of television time to political candidates, and to protect children from some types of programming. Sure, laugh at the French. But not for too long. The United States has similarly busy-bodied regulators, who, for example, have primly regulated such advertising themselves. American regulators carefully oversee non-secret advertising, too. Our govern... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4902405 Mon, 06 Jun 2011 16:35:53 +0100 4902405 http://www.medworm.com/index.php?rid=4862924&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPY8LOK5kv_0%2F Once again, the US Federal Trade Commission is trying to thwart pay-to-delays deals and its latest effort is a brief in which the agency has asked an appeals court to reverse a lower court ruling that sanctioned a settlement between Schering-Plough and two generic drugmakers - Upsher Smith and ESI, which was a division of Pfizer’s Wyeth - over the K-Dur blood pressure med. The background: In 1995, the two generic drugmakers sought FDA approval to sell versions of K-Dur, but Schering-Plough, now owned by Merck, filed suit for patent infringement. Just before the trial, Schering-Plough agreed to pay Upsher $60 million not to sell a generic until 2001, and the FTC filed suit (read here). Separately, Schering-Plough agreed to pay ESI up to $15 million to agree not to sell a generic until... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862924 Wed, 25 May 2011 12:02:39 +0100 4862924 http://www.medworm.com/index.php?rid=4789641&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F919qtSMsjE4%2F Despite setbacks in courts and Congress, the Federal Trade Commission continues to hammer away at pay-to-delay deals involving patent settlements between brand-name and generic drugmakers. The agency views these deals as anti-competitive, arguing they rob consumers of lower-cost meds that might otherwise arrive much sooner in pharmacies. And so the FTC chair Jon Leibowitz has released yet another report that he hopes will generate some momentum in Congress toward restricting these agreements. The report found there 31 deals in fiscal year 2010, a 63 percent increase from fiscal year 2009. The deals reached in the last year involved 22 different brand-name meds with combined annual US sales of about $9.3 billion. Of the 31 settlements, 26 involved generics that were “first filers,” whic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789641 Wed, 04 May 2011 12:39:30 +0100 4789641 http://www.medworm.com/index.php?rid=4715014&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpYq3k6eZCQ4%2F Four years after the merger between the CVS drugstore chain and the Caremark pharmacy benefits manager, which has spurred numerous investigations and lawsuits over anticompetitive concerns, a handful of consumer groups have written the US Federal Trade Commission to ask the agency to break up the company. Why? The groups charge CVS Caremark limits choice through various programs, the merger has given CVS unfair advantage over other retailers, patients are steered toward CVS and confidential patient information is improperly shared. Such concerns have already prompted investigations by the FTC and attorneys general of 24 states. CVS Caremark has previously said it is cooperating with the probes. “There is strong evidence that the CVS Caremark merger has harmed consumers,” says the lett... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4715014 Fri, 15 Apr 2011 12:18:08 +0100 4715014 http://www.medworm.com/index.php?rid=4676779&cid=t_169632_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2FQjV-tryLFQ4%2F By Glenna Crooks. Having been engaged in rare disease research and orphan drug development for many decades and as one who continues behind-the-scenes to encourage the work, events of the last few weeks about Makena’s launch sent chills through me.  The firestorm that followed created some heat but none sufficient to help relieve the shivers. Others might declare the outcome a “win” but the more I read, the worse it seems. I’m not privy to what really happened, only what the press reports. It does not look good… for virtually anyone of the players involved, especially the critics.  Those critics raised tough questions and to date only the company has faced them. It’s about time the critics themselves –and perhaps others as well – face some.    For those who’ve mi... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=4676779 Mon, 04 Apr 2011 09:31:25 +0100 4676779 http://www.medworm.com/index.php?rid=4664471&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBooQH9h2fi8%2F Under enormous political pressure and undercut by an unexpected FDA decision earlier this week, KV Pharmaceuticals has lowered the price of its Makena injectable drug for premature births by nearly 55 percent, to $690 per injection. Previously, KV hoped to charge $1,500. Despite the decrease, this is still considerably more than the $10 to $20 that compounding pharmacies typically charge. Nonetheless, KV maintains the price drop, supplemental rebates and the standard 23.1 percent Medicaid rebate “will result in a substantially reduced cost per injection for state Medicaid agencies compared to list price. This will help ensure that every woman who is prescribed Makena – regardless of her ability to pay – has the comfort of knowing a medication that has been rigorously reviewed by ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4664471 Fri, 01 Apr 2011 15:18:27 +0100 4664471 http://www.medworm.com/index.php?rid=4658621&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_coAu5MMn48%2F In response to threats KV Pharmaceuticals has made to compounding pharmacies that want to continue making low-cost versions of its high-priced Makena preemie drug, the FDA has just issued a statement saying the agency will not take any “enforcement actions” against compounders. The “FDA understands that the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct,” the FDA statement says. “In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid pr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658621 Wed, 30 Mar 2011 14:43:43 +0100 4658621 http://www.medworm.com/index.php?rid=4658625&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FywfQAM3CoRc%2F Earlier this month, controversy erupted after KV Pharmaceuticals began charging $1,500 for an injection of its Makena drug for preventing premature births. Why? Makena is actually a form of progesterone that has been available for decades from compounding pharmacies at roughly $10 to $20 a week (read this and this). Now, though, KV Pharma has a lock on the market, because Makena is the only drug approved by the FDA for this purpose. Two US senators, however, asked the US Federal Trade Commission to investigate and various patient groups are pressuring KV to lower its price. We spoke with Alan Fleischman, medical director at the March of Dimes, which has received some $1 million in donations from KV over the past decade, but issued a harsh condemnation (see this). This chat occurred just be... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658625 Wed, 30 Mar 2011 12:22:30 +0100 4658625 http://www.medworm.com/index.php?rid=4560597&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC7Wu-i1zM6o%2F Hello, everyone, and top of the morning to you. Another shiny day is unfolding here on the Pharmalot corporate campus, where we are hustling the short people off to their various school houses for some learning. And this marathon calls for a much needed cup of stimulation - our flavor today is Cinnamon Cream Swirl. Please join us as we also peruse the news for interesting developments. As always, we encourage you to contact us if you hear of something noteworthy. Meanwhile, have a great day… FDA Warns About Abbott HIV Med In Premature Babies (Reuters) Teva Says Docs Contacted For Generic Copaxone Study (Bloomberg News) FDA Accepts Application For Astra & Bristol Diabetes Drug (Associated Press) Japan Finds No Direct Link To Vaccines And Deaths (Reuters) FTC Takes Aim At Patent T... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4560597 Tue, 08 Mar 2011 12:53:17 +0100 4560597 http://www.medworm.com/index.php?rid=4560598&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDDJwXnTTp4M%2F The Supreme Court rejected a challenge to a pay-to-delay deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop a patent lawsuit over the Cipro antibiotic (see this). The move is a blow to the Federal Trade Commission, which calls the deals anticompetitive and had been hoping the Supreme Court would review a case in the face of legislative inactivity. The issue has divided lower courts around the country for years. A wholesaler and three retailers, including CVS and Rite-Aid, asked the Supreme Court to review the settlement, arguing the deals choke off competition by stifling the arrival of lower-cost generics on their shelves. In the case they cited, Barr challenged the Cipro patent in October 1991 and struck a deal with Bayer in January 1997 tw... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4560598 Mon, 07 Mar 2011 22:44:07 +0100 4560598 http://www.medworm.com/index.php?rid=4495432&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhzVMM9bdJ8U%2F A handful of Senate Democrats have revived a bill that would restrict brand-name drugmakers from being able to market an authorized generic during the 180-day exclusivity period that follows the first successful challenge to a patent by a generic rival. Known as the Fair Prescription Drug Competition Act, the bill was first introduced by US Senator Jay Rockefeller, a West Virginia Democrat, in 2007. Authorized generics, as you know, may be sold by brand-name drugmakers after a patent expires, although marketed differently. However, a 2009 report by the US Federal Trade Commission found that consumers are harmed by deals between brand-name and generic drugmakers in which a generic entry is delayed. The FTC noted that the arrival of an authorized generic during that 180-day exclusivity perio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4495432 Fri, 18 Feb 2011 17:10:06 +0100 4495432 http://www.medworm.com/index.php?rid=4399818&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVytK4mo5a_A%2F A pair of US Senators have reintroduced legislation that would limit the so-called pay-to-delay deals that remain one of the hottest controversies enveloping the pharmaceutical industry. The move comes after the House and Senate last month failed to agree on an appropriations bill, which included pay-to-delay restrictions. You may recall that pay-to-delay settlements involve agreements in which brand-name and generic drugmakers settle patent disputes by exchanging a payment for a commitment to refrain from marketing a generic off the market for a set period of time. However, the Federal Trade Commission calls these deals anti-competitive and force consumers and government healthcare programs to pay high prices. A Congressional Budget Office report estimated the federal government could sav... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4399818 Wed, 26 Jan 2011 18:11:24 +0100 4399818 http://www.medworm.com/index.php?rid=4377787&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcjCmn3mBJKE%2F Two years ago, the US Federal Trade Commission filed a highly publicized lawsuit against Cephalon over pay-to-delay deals worth an estimated $200 million with some generic drugmakers - Ranbaxy Labs, Mylan Labs and Teva Pharmaceuticals - to keep a copycat version of its Provigil sleep-disorder pill off the market until 2012 (read this). Now, though, more than three dozen other drugmakers have raced to court to try to keep details of their own deals from being disclosed as a result of this battle. In a motion filed in federal court in Philadelphia this week, no fewer than 37 drugmakers - including Abbott Laboratories, Merck, Novartis, Bristol-Myers Squibb, Sanofi-Aventis, GlaxoSmithKline, Pfizer, Bayer, AstraZeneca, Johnson & Johnson, Actavis, Waston Pharmaceuticals, Dr. Reddy’s, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4377787 Thu, 20 Jan 2011 20:48:02 +0100 4377787 http://www.medworm.com/index.php?rid=4361306&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUuhSDJneggs%2F One month after yet again raiding offices of various drugmakers (back story), the European Commission is now taking a more polite approach and telling several companies - including Bayer and Roche - to submit details of their settlements over patent disputes. The EC asked a “selected number of originator and generic companies” to submit a copy of all patent settlement agreements relevant to the 27-member EU region and which were concluded between Jan. 1, 2010 and Dec. 31, 2010, according to an EC statement. Like the US Federal Trade Commission, the EC has been probing these pay-to-delay deals in the belief that they stifle competition and, therefore, delay entry to the marketplace of lower-cost medicines (read about the FTC efforts here). This followed a report from the Europe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4361306 Tue, 18 Jan 2011 14:20:42 +0100 4361306 http://www.medworm.com/index.php?rid=4331236&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FED0DYDEIm1U%2F The controversy over so-called pay-to-delay settlements between brand-name and generic drugmakers has prompted attorneys general from 32 states to file an amicus, or friend-of-the-court brief urging the US Supreme Court to review the deals, which the states say thwart competition and block needed access to lower-cost medications. The move comes less than a month after three pharmacy chains and a wholesaler petitioned the court to rule on the issue, which has divided other federal courts (see this) and spurred the Federal Trade Commission into a Quixotic quest to urge Congress to pass a law to restrict these deals (back story). The case that precipitated these filings involved a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent cha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331236 Tue, 11 Jan 2011 13:26:37 +0100 4331236 http://www.medworm.com/index.php?rid=4281300&cid=t_169632_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FEndHZeya-Tg%2F By Jim HarperIs there something special about December? Perhaps it’s the spirit of giving that had the Federal Communications Commission voting yesterday to regulate Internet service. At the beginning of the month—December 1st—the Federal Trade Commission issued a report signaling its willingness to regulate online businesses. No, it’s not the fact that it’s December. It’s the fact that it’s after November. November—that’s the month when we had the mid-term election. The FCC and FTC appear to have held off coming out with their regulatory proposals ahead of the elections because the Obama administration couldn’t afford any more evidence that it heavily favors government control of the economy and society. There was already plen... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4281300 Wed, 22 Dec 2010 14:29:57 +0100 4281300 http://www.medworm.com/index.php?rid=4272601&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpAmBhLecykw%2F The controversy over the so-called pay-to-delay settlements is bubbling up to the US Supreme Court. Three pharmacy chains and a wholesaler have asked the court to review the issue because they maintain the deals choke off competition by stifling the arrival of lower-cost generics on their shelves. The issue has become a cause celebre for the US Federal Trade Commission (look here), which has been lobbying Congress to enact legislation to restrict the settlements, and has also divided courts across the country, which is why the Supreme Court was asked to review the topic and settle the matter. The case cited by the retailers and wholesaler involved a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent challenge to the Cipro antibiot... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4272601 Mon, 20 Dec 2010 15:41:59 +0100 4272601 http://www.medworm.com/index.php?rid=4233157&cid=t_169632_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FC5UQA15ub3c%2F By Julian SanchezA subcommittee of the House Committee on Energy and Commerce held a hearing last week to consider a proposal, floated in a recent Federal Trade Commission report, for “Do Not Track” legislation aimed at giving Web users greater control over how information about their online activities is collected and used by sites and advertisers. The name is a deliberate reference to the wildly popular “Do Not Call” list, a sort of virtual “No Tresspassing” sign for the telephone, which has spared scores of Americans the annoyance of telemarketers pitching FABULOUS DEALS! and LOW INTEREST RATES! during dinner. Subcommittee Chair Bobby Rush repeatedly invoked the Do Not Call program’s success in his opening remarks. And under the headline “... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4233157 Mon, 06 Dec 2010 21:57:02 +0100 4233157 http://www.medworm.com/index.php?rid=4233422&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC-wivyYh71k%2F For the past year, Watson Pharmaceutical ceo Paul Bisaro has argued the Federal Trade Commission abused its power in attempting to stop a pay-for-delay deal. And he giddily thumbed his nose at the agency by refusing to comply with a subpoena that sought to compel him to testify in connection with an investigation into the deal. Late last week, however, a federal judge burst his bubble by ruling that he failed to demonstrate” the subpoena “would be burdensome at all, let alone unduly so.” Here’s the background: in court papers, Bisaro claimed the FTC harassed Watson and used confidential FDA info to force Watson into a deal with Apotex, another generic drugmaker, to sell a version of Cephalon’s Provigil, a sleep-disorder drug. Bisaro asserted the FTC initiated its investigati... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4233422 Mon, 06 Dec 2010 13:34:19 +0100 4233422 http://www.medworm.com/index.php?rid=4233424&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F69Q-JUDmm-A%2F Welcome to the working week. We hope the weekend was refreshing and restful, although now, of course, the routine resumes. To prepare, we are brewing the mandatory cup of stimulation. Meanwhile, we would like to note that we are hosting a webinar on Thurs., Dec. 9 about the FDA’s Accelerated Approval process (please look here). Please join us. And now, the news of the world. Have a great day and if you run into Jeff Kindler, please send our regards… Celgene Stock Hurt By Revlimid Cancer Data (TheStreet) Elan Replaces Martin With Former Glaxo CEO Ingram (Bloomberg News) AstraZeneca Bloodthinner Gets EU Approval (Reuters) FDA Delays Decision On Benlysta Lupus Med (Associated Press) China To Lead Innovation By 2020: AstraZeneca Survey (PharmaTimes) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4233424 Mon, 06 Dec 2010 12:45:55 +0100 4233424 http://www.medworm.com/index.php?rid=4207339&cid=t_169632_109_f&fid=34761&url=http%3A%2F%2Ffeeds.feedblitz.com%2F%7E%2F22441660%2F0%2Fneuromarketing%7ENeuromarketing-Pharma-Threat.htm Some people find drug company marketing reprehensible, and apparently nobody more so than these four organizations: the Center for Digital Democracy, U.S. PIRG, Consumer Watchdog, and the World Privacy Forum. They have filed a complaint with the Federal Trade Commission accusing drug companies of everything except kidnapping and insider trading. The complaint runs to 144-pages, [...] CommentsCommentsRelated StoriesLove BrandingSubliminal MotivationAvoid the Corner of Death! (Source: Neuromarketing) Neuromarketing blogs http://www.medworm.com/rss/comments.php?id=4207339 Mon, 29 Nov 2010 11:01:32 +0100 4207339 http://www.medworm.com/index.php?rid=4197362&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU2jO9cXPUTo%2F The US Federal Trade Commission is being asked by four consumer and privacy watchdog groups to investigate what they describe as allegedly “unfair and deceptive advertising practices” that consumers confront when they attempt to gather health info online. The move comes as the FDA grapples with formulating rules for how the pharmaceutical industry can adopt social media. “Health consumers are being told that by using digital media services they have become empowered ‘e-patients,’ but they are not being informed about the privacy and potential health risks connected with the use of digital marketing of pharmaceuticals and health products,” according to the 144-page complaint filed today with the FTC by the Center for Digital Democracy, US PIRG, Consumer ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4197362 Tue, 23 Nov 2010 18:20:17 +0100 4197362 http://www.medworm.com/index.php?rid=4175672&cid=t_169632_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F0ca85Zl1YrE%2F By Walter OlsonI had an op-ed in the Washington Times yesterday on government’s growing participation in public-health scare campaigns demonizing everyday foods that are fattening, salty, or thought to be bad for us in other ways. In particular, I singled out Mayor Michael Bloomberg’s New York City Department of Health, which has followed up one scientifically dubious ad campaign on sweetened soft drinks (“What can we get away with?” asked one official) with an even worse — in fact, grossly misleading and manipulative — attack on salt in processed foods: It shows a can of soup bursting at the seams with table salt, whole mounds and piles of it. The city’s underlying point is not 100 percent off-base – healthful in most other ways, convention... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4175672 Wed, 17 Nov 2010 21:00:57 +0100 4175672 http://www.medworm.com/index.php?rid=4119717&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMG3RQRES24g%2F Will Congress ever pass a bill that limits pay-to-delay deals? The Federal Trade Commission has been trying to convince Congress for months to do so, but opposition is mounting. Five Democratic Senators are objecting to a bill recently passed by the Senate Appropriations Committee because it contains a provision that would restrict these patent settlements (see this). In a letter to Senate Majority Leader Harry Reid, the endangered Nevada Democrat, and Appropriations Committee chairman Daniel Inouye, a Democrat from Hawaii, the Democrats say they have “substantive concerns with the content” of the provision and that the decision to include it in the appropriations bill “contradicts both the spirit and the letter of the Senate rules” (see the letter). Why bother to ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4119717 Thu, 28 Oct 2010 21:34:10 +0100 4119717 http://www.medworm.com/index.php?rid=3946687&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FT2IYaC17BMc%2F In yet another blow to the US Federal Trade Commission, a federal appeals court has refused to reconsider its ruling last April that upheld the legality of so-called pay-for-delay deals that thwart the introduction of generic rivals (here is the order). However, in a dissenting opinion, Justice Rosemary Pooler writes that the issue must ultimately be decided by the US Supreme Court, given the conflicting outcomes in various cases. The initial ruling by the US Second Circuit Court of Appeals was made after reviewing a deal in which Bayer paid Barr Pharmaceuticals, which is now owned by Teva Pharmaceuticals, to drop its patent challenge to the Cipro antibiotic. Barr challenged the Cipro patent in October 1991 and struck a deal with Bayer in January 1997, about two weeks before the case was s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3946687 Wed, 08 Sep 2010 12:03:05 +0100 3946687 http://www.medworm.com/index.php?rid=3865456&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVdgbM3QaGSA%2F For months, US Federal Trade Commission commish Jon Leibowitz has argued that passing legislation to restrict pay-for-delay deals between brand name and generic drugmakers will save consumers billions of dollars over the next decade (back story). He has pointed to a Congressional Budget Office study forecasting nearly $2 billion in savings over 10 years and an FTC study that estimates savings of $3.5 billion annually. And he has maintained restrictions would speed the arrival of low-cost generics by more than a year onto pharmacy shelves. Now, a new study claims the CBO report “is flawed and likely substantially overestimates the budgetary savings,” and also claims that restrictions may have the opposite effect. “Under many circumstances, reverse payment patent settlemen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3865456 Fri, 13 Aug 2010 15:28:09 +0100 3865456 http://www.medworm.com/index.php?rid=3806023&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7SvmpDcngfs%2F In yet another legislative bid to tackle pay-to-delay deals, the US Senate Appropriations Committee voted yesterday to pass the Preserve Access to Affordable Generic Drugs Act, which was included in the Financial Services and General Government Appropriations bill reported out of the committee. A companion House bill was recently passed as part of the Supplemental Appropriations Act of 2010. The Congressional Budget Office estimates the House bill would save the federal government $2.6 billion over 10 years by reducing drug costs. “The cost of brand-name drugs rose nearly ten percent last year. In contrast, the cost of generic drugs fell by nearly ten percent. At this time of spiraling health care costs, we cannot turn a blind eye to these anticompetitive backroom deals that deny consume... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3806023 Fri, 30 Jul 2010 13:06:17 +0100 3806023 http://www.medworm.com/index.php?rid=3802587&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsYwntWuqtGs%2F Despite various legislative and courtroom setbacks, FTC commish Jon Leibowitz insists there is reason to be optimistic that so-called pay-to-delay deals may soon be a thing of the past. In testimony this week before the House Committee on the Judiciary’s Subcommittee on Courts and Competition Policy, he appeared to see blue skies on his horizon and went so far as to say the ‘tide may be turning.’ For instance, he cited a recent ruling by the US Second Circuirt Court of Appeals, which actually upheld the legality of pay-for-delay deals, but at the same time, took the unusual step of inviting entities that purchase drugs and had challenged a particular deal to ask for that case to be reviewed by the full circuit, citing the “exceptional importance” of the antitrust impl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3802587 Thu, 29 Jul 2010 12:47:40 +0100 3802587 http://www.medworm.com/index.php?rid=3767314&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVAkuw91uRH4%2F Two months ago, Paul Bisaro, the ceo of Watson Pharmaceuticals, made a sensational charge against the Federal Trade Commission - in court papers, he accused the agency of abusing its power in attempting to stop pay-for-delay deals. Bisaro claimed the FTC harassed his company and used confidential FDA info to force Watson to strike a deal with Apotex, another generic drugmaker, to sell a version of Cephalon’s Provigil, a sleep-disorder drug. The FTC is challenging a 2005 deal between Cephalon and several generic drugmakers that were paid $300 million by arguing the payments bought market exclusivity. The FTC issued a subpoena last year and sought to compel Bisaro to respond to questions in connection with an investigation into that deal, although he refused to testify. Bisaro claims the F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3767314 Mon, 19 Jul 2010 12:23:08 +0100 3767314 http://www.medworm.com/index.php?rid=3730095&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyREbKSL71QY%2F A watchdog group has asked the Federal Trade Commission to investigate contract pricing arrangements that Merck and Sanofi-Pasteur offer physician practices. In a letter to the FTC, the Citizens for Responsibility and Ethics in Washington allege the vaccine makers offer docs significant discounts, but only after signing contracts prohibiting them from purchase vaccines made by rivals. To make its case, CREW cites memos and emails written by four different physician groups in which its doctors are reminded to purchase only vaccines from Sanofi-Pasteur or Merck if they want to obtain the best prices. The vaccines include Merck’s Gardasil for HPV, Rotateq for rotavirus, and Recombivax for hepatitis B, while the Sanofi vaccines include several products, notably Menactra for meningitis. C... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3730095 Tue, 06 Jul 2010 15:25:47 +0100 3730095 http://www.medworm.com/index.php?rid=3721960&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F28WlTkAyHMw%2F A proposal to end those controversial ‘pay-to-delay’ deals between brand-name and generic drugmakers was passed by the House of Representatives last night as part of a measure to fund wars. Ironic, yes? Or maybe appropriate. In any event, the bill now goes to the Senate, Bloomberg News reports. Under the proposal, drugmakers could be fined if the Federal Trade Commission or the courts determine they struck deals to preserve a brand-name drug patent by delaying introduction of a lower-priced generic equivalent (see page 74). This is “just another signal of the growing support in Congress for ending this unconscionable behavior by some pharmaceutical companies,” FTC chairman Jon Leibowitz tells the news service. The FTC, you may recall, has made a mission of ending these dea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3721960 Fri, 02 Jul 2010 12:55:23 +0100 3721960 http://www.medworm.com/index.php?rid=3648802&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEpJ0J1P_UBk%2F Hello, everyone. Nice to see you again. A spot of rain is falling here on the Pharmalot corporate campus, but our spirits remain sunny. We look forward, in fact, to a productive day filled with interesting items and interesting meetings. Hopefully, your day will be as fruitful. To help you along, here are some snippets from the news of the world. Have a good one… Hospira Approved For 2nd Biogeneric (Reuters) CVS Will Eliminate Walgreen From PBM Network (Associated Press) Glaxo Buys Argentine Drugmaker (Reuters) Senators Press FTC On Watson Allegations (Dow Jones) Glaxo Says Reports Of Irish Ops Review Are Inaccurate (InPharmaTechnologist) Human Genome Says Cancer Drug Failed To Improve Survival (Reuters) Unitaid Launches Patent Pool For HIV/AIDS Drugs (ICTSD) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3648802 Thu, 10 Jun 2010 11:44:18 +0100 3648802 http://www.medworm.com/index.php?rid=3607817&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTSbBPhHxMwU%2F Here’s a sensational accusation for you. Paul Bisaro, the ceo of Watson Pharmaceuticals, filed papers in federal court the other day accusing the Federal Trade Commission of abusing its power in attempting to stop pay-for-delay deals, which the agency argues are anti-competitive and, therefore, harm consumers (see background). Bisaro claims the FTC harassed his company and used confidential FDA info in an effort to force Watson to strike a deal with Apotex, another generic drugmaker, to sell a version of Cephalon’s Provigil, a sleep-disorder drug. The FTC is challenging a 2005 deal between Cephalon and several generic drugmakers that were paid $300 million by arguing the payments bought market exclusivity. His charge follows a subpoena sought last year by the FTC to compel Bis... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3607817 Thu, 27 May 2010 18:06:48 +0100 3607817 http://www.medworm.com/index.php?rid=3599738&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOgrZm0fTE7A%2F Rise and shine. Another day awaits. And who knows what lies ahead? Meetings? Deadlines? Unexpected tidbits of information? We can relate. So grab a cup of stimulation - or perhaps, a bottle of water, since it will be rather sticky today in the greater Pharmalot metropolitan region - and dive in. As always, here are some items to ease the process. Have a great day everyone and stay in touch… UK’s NICE Won’t Cover Bayer Liver Cancer Drug (Bloomberg News) AMRI Cuts US Workforce 10% And Shifts Jobs To Asia (OutsourcingPharma) FTC Commish Remains Bullish On Ending Pay-To-Delay Deals (PharmaTimes) Dennis Quaid Sues Baxter Over Heparin Overdose (USA Today) Merck Will Not Raise Its Dividend (Associated Press) Sanofi-Aventis Will Reassign Global Media Ad Duties (MM&M) Photo t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3599738 Wed, 26 May 2010 11:48:29 +0100 3599738 http://www.medworm.com/index.php?rid=3577626&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh_IpIo82H4Y%2F A federal appeals court last month may have upheld the legality of pay-for-delay deals that thwart the introduction of generics, but the issue isn’t dead yet. A group of consumers, union health and welfare funds, which have been certified as a class, are asking a California appeals court to review the same set of circumstances involving Bayer, Barr Pharmaceuticals and the Cipro antibiotic. At issue in both cases is a deal in which Bayer paid Barr, now owed by Teva Pharmaceuticals, to drop its 1991 patent challenge to Cipro. In 1997, Barr struck a deal with Bayer just two weeks before a lawsuit was set to go to trial, delaying the entrance of a generic version. The US Second Circuirt Court of Appeals ruled the deal was kosher (see here), although the Federal Trade Commission continues... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3577626 Wed, 19 May 2010 12:11:47 +0100 3577626 http://www.medworm.com/index.php?rid=3538075&cid=t_169632_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FZqxmoUScElE%2F By Walter OlsonI’m usually in enthusiastic accord with our friends over at the Competitive Enterprise Institute, but it seems to me they’ve made a mistake by petitioning the Federal Trade Commission (FTC) to crack down on GM’s ridiculous “we repaid our federal loan” ad. Some zealous enforcers would love for the FTC to do more to regulate speech by American business on matters of public concern, and it seems to me the last thing we should do is encourage such a trend. For those who came in late, General Motors and its CEO Ed Whitmire were widely and rightly assailed here and elsewhere for asserting (in a column whose message was repeated in much-played TV ads) that the company had repaid its bailout loan “in full, with interest, years ahead of schedule.&#... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3538075 Wed, 05 May 2010 19:11:47 +0100 3538075 http://www.medworm.com/index.php?rid=3519709&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLrxAf4BduMM%2F In a blow to the Federal Trade Commission, the US Second Circuirt Court of Appeals has upheld the legality of so-called pay-for-delay deals that thwart the introduction of generic rivals. But at the same time, the court suggested the issue needed further review (see the ruling). The ruling was made after reviewing a deal in which Bayer paid Barr Pharmaceuticals, which is now owed by Teva Pharmaceuticals, to drop its patent challenge to the Cipro antibiotic. Barr challenged the Cipro patent in October 1991 and struck a deal with Bayer in January 1997, about two weeks before the case was set to go to trial. The ruling is yet another setback for the Federal Trade Commission, which has been pushing aggressively to end pay-to-delay deals (look here). Two months ago, a federal judge dismissed an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3519709 Fri, 30 Apr 2010 12:17:52 +0100 3519709 http://www.medworm.com/index.php?rid=3382796&cid=t_169632_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FT8OxLguD9zw%2F By Jim HarperWriting on the TechLiberationFront blog, Berin Szoka warns of the extensive Internet regulation that could come with huge grants of authority to the Federal Trade Commission in H.R. 4173, the “Wall Street Reform and Consumer Protection Act of 2009.” Congress is about to reinvent the FTC as the “National Nanny” it was well on its way to becoming back in the 1970s.  Today, the FTC is not merely the general overseer of our economy, but the key regulator of the Internet.  If the Senate passes Rep. Frank’s bill with its so-called “improvements” to the FTC Act, future generations will look back and wonder why, without even taking the time to consider what it was doing, Congress radically transformed Internet governance as an afterthought to financial regulat... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3382796 Fri, 19 Mar 2010 14:53:09 +0100 3382796 http://www.medworm.com/index.php?rid=3378729&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl_d81VsC3bA%2F The amendment was dropped from part of the health care reform bill because of concerns it wouldn’t pass muster with congressional rules, according to a spokeswoman for Senator Herb Kohl, a Wisconsin Democrat who chairs the Special Committee on Aging, which yesterday held a hearing on drug prices. The proposal was vigorously supported by the Federal Trade Commission, which argues that so-called pay-to-delay deals hurt consumers by delaying the launch of lower-cost generics (background here). The proposed amendment would have made it harder for brand-name drugmakers to settle patent challenges brought by generic companies. Kohl plans to pursue the ban after health care reform is settled, according to The Wall Street Journal. Kathleen Jaeger, president the Generic Pharmaceutical Associ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3378729 Thu, 18 Mar 2010 12:39:38 +0100 3378729 http://www.medworm.com/index.php?rid=3302634&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fk55qOTJU1vI%2F A federal judge dismissed an antitrust lawsuit filed by the Federal Trade Commission against Abbott Labs’s Solvay Pharmaceuticals unit for allegedly conspiring with several generic drug makers to delay competition for its AndroGel testosterone-replacement med (here is the ruling). The ruling is a setback for the agency, which has been pushing aggressively to end so-called pay-to-delay deals (look here). The White House, in fact, included a proposal to make these agreements illegal as part of its health care reform package (see here). The FTC alleged Solvay entered into illegal deals with Watson Pharmaceuticals, Par Pharmaceutical and Paddock Labs to delay introduction of a generic AndroGel. The generics sought FDA approval and, in their submissions, noted their copycats wouldn’... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3302634 Wed, 24 Feb 2010 12:45:00 +0100 3302634 http://www.medworm.com/index.php?rid=3239813&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_ECqsUBQhaY%2F In response to recent merger activity, the agency is seeking a budget of $314 million, which amounts to a 22 percent increase, in fiscal year 2011. This would pay for 1,207 full-time staff members, up from 40 this year, and would include 17 people to “maintain competition.” Of those, nine would be tasked with the “increased workload” caused by increasingly complex mergers, notably in pharma, health care, energy and technology. And four of the nine would oversee pharma and tech deals. “Preventing anticompetitive pharmaceutical mergers will continue to be an important priority for the FTC and a vital way to protect consumers from rising drug prices,” the agency wrote in its budget summary. As The Pink Sheet notes, the White House has already shown interest... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3239813 Thu, 04 Feb 2010 13:18:39 +0100 3239813 http://www.medworm.com/index.php?rid=3167443&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzFPXsQVcoi8%2F In his never-ending quest, FTC commish Jon Leibowitz will hold a press conference today to ask Congress to include a provision in the health care reform bill to end deals in which brand-name drugmakers offer payments or other inducments to generic rivals to delay copycat versions of best-selling meds. He’ll be appearing at the Rayburn House Office Building in Washington, DC, at 12:30 along with several members of the House, which has already included a ban in its own bill. The Congressional Budget Office, you may recall, recently estimated that the House provision could save the government $1.8 billion in health costs over the next 10 years (see here). The Senate version does not include a ban (see here), although nine Democrats last month sent a letter to majority leader Harry Reid ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3167443 Wed, 13 Jan 2010 15:15:00 +0100 3167443 http://www.medworm.com/index.php?rid=3052127&cid=t_169632_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FYBvsqTfHpCo%2F The Associated Press reports: The federal government is wading into deliberations over the future of journalism as printed newspapers, television stations and other traditional media outlets suffer from Americans’ growing reliance on the Internet. With the media business in a state of economic distress as audiences and advertisers migrate online, the Federal Trade Commission began a two-day workshop Tuesday to examine the profound challenges facing media companies and explore ways the government can help them survive. Media executives taking part are looking for a new business model for an industry that is watching traditional advertising revenue dry up, without online revenue growing quickly enough to replace it. Government officials want to protect a critical pillar of democracy—... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3052127 Wed, 02 Dec 2009 19:43:21 +0100 3052127 http://www.medworm.com/index.php?rid=3045023&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0jJwPStVWMc%2F The drugmakers finally found a way to resolve litigation that began a decade ago over Abbott Labs’ TriCor cholesterol drug, which generated more than $1 billion in US sales last year. Teva sought to sell a generic version, but as part of their settlement, agreed to postpone such a move untill March 2011. Terms, however, weren’t disclosed in this SEC filing made by Abbott. An Abbott spokeswoman tells The Wall Street Journal that Teva isn’t being paid to delay selling a generic, and calls the deal a “pure licensing agreement.” Laboratoires Fournier SA of France, which discovered the drug, also agreed to the settlement. For the record, drugmakers have often struck deals with generic rivals in which they agreed to make a payment or offered them something else to ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3045023 Tue, 01 Dec 2009 12:50:29 +0100 3045023 http://www.medworm.com/index.php?rid=3008401&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnauR90jH7zA%2F Who? Julie Brill, who was Vermont’s assistant attorney general for consumer protection and antitrust, where she spearheaded efforts to publicize pharma payments to docs and reign in some marketing practices, The Pink Sheet writes*. She championed, for instance, a controversial data mining law (see here). Brill worked in Vermont from 1988 to 2009 before moving earlier this year to North Carolina, where she is senior deputy attorney general in charge of the consumer protection division. If she makes the cut, she will become one of five FTC commissioners. Full disclosure: Ed Silverman is an editor at The Pink Sheet (* - subscription required) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3008401 Thu, 19 Nov 2009 12:41:10 +0100 3008401 http://www.medworm.com/index.php?rid=2989407&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEPI2fCRrB0I%2F The Federal Trade Commission is concerned that some brand-name drugmakers are declining to supply some bulk ingredients to their generic rivals which, of course, want to use materials to make copies of more expensive meds, The Wall Street Journal writes. Meanwhile, GlaxoSmithKline cites a federal drug-safety program as its reason for declining to supply bulk quantities of certain drugs, the paper continues. Why? They maintain the generics aren’t authorized to buy drugs under the program, the paper continues. Naturally, the generics calls this a transparent excuse to block competition. “We’re going to be very concerned about any practice that could increase prescription-drug costs to American consumers,” FTC chairman Jon Leibowitz tells the Journal, although he decl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2989407 Fri, 13 Nov 2009 13:05:58 +0100 2989407 http://www.medworm.com/index.php?rid=2899198&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrjCHmpTErNk%2F The Senate Judiciary Committee passed a bill making it harder for drug makers to strike those ‘pay-for-delay’ deals in which a brand-name pharma company shovels some money to a generic maker to hold off introducing a lower-priced copycat medication. The bill, which reports say passed 12-7 along party lines, would allow drug makers to strike a deal only if they provide ‘clear and convincing evidence’ that an agreement doesn’t stymie competition. How that will be proven is unclear. Herb Kohl, the Wisconsin Democrat who introduced the bill, opposes any attempt to lower the threshold of evidence, although the bill was originally tougher - it would have banned these deals altogether. The Federal Trade Commission, which opposes ‘pay-to-delay’ deals as a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2899198 Thu, 15 Oct 2009 21:58:39 +0100 2899198 http://www.medworm.com/index.php?rid=2865641&cid=t_169632_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FqKJtIi6Cw_w%2F Lovers of free speech should feel their stomachs turn when they look at the actions of the Federal Trade Commission and Federal Communications Commission these days. Not that they took a sharp turn with the Obama administration, or with the chairmanships of Jon Leibowitz or Jules Genachowski. These are run-of-the-mill bureaucracies, constantly reaching for new powers, nevermind even constitutional limits on the federal government’s authority. Item 1: Blogger, You’re an Advertiser Now Via the L.A. Times blog, the FTC issued a guidance document yesterday requiring bloggers who write testimonials about products to disclose large gifts or payments, or they will run afoul of the FTC’s regulations on advertising. Is that the right thing to do? Yep. Is that an appropriate thing to r... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2865641 Tue, 06 Oct 2009 13:20:13 +0100 2865641 http://www.medworm.com/index.php?rid=2424227&cid=t_169632_113_f&fid=38236&url=http%3A%2F%2Fwww.healthcareitnews.com%2Fblog%2Fphr-evolution I participated in a personal health record (PHR) workshop yesterday hosted by the Center for Democracy and Technology (CDT). CDT’s goal was to gain input from a wide array of stakeholders (an impressive collection of about 40 health care leaders with different types of expertise in PHRs) to help inform CDT’s recommendations to federal agencies - HHS and the Federal Trade Commission (FTC) - and try to build some degree of consensus among key stakeholders. (Source: Healthcare IT News Blog) Healthcare IT News Blog blogs http://www.medworm.com/rss/comments.php?id=2424227 Wed, 20 May 2009 14:25:39 +0100 2424227 http://www.medworm.com/index.php?rid=2047635&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F486884969%2F The Federal Trade Commission filed a civil lawsuit claiming that Ovation Pharmaceuticals illegally maintained a monopoly by purchasing the only two meds approved to treat premature babies born with a potentially life-threatening congenital heart defect - and then raised prices by 1,300 percent. And so the FTC wants the drugmaker to divest either of the two drugs - NeoProfen and Indocin - and also forfeit all “unlawfully obtained profits,” according to the lawsuit filed in federal court in Minnesota. In the suit, the FTC says Ovation purchased the rights to Indocin in August 2005 from Merck and, five months later, acquired the rights to NeoProfen, which was about to be approved by the FDA, in order to “eliminate (a) competitive threat.” After buying NeoProfen, Ovatio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2047635 Tue, 16 Dec 2008 19:35:33 +0100 2047635 http://www.medworm.com/index.php?rid=1981289&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F458346037%2F This topic may have fallen off the radar screen amid the presidential election and the recession, but the rising cost of biologics continues to be a problem. And the Federal Trade Commission wants to shape the discussion before Congress and the FDA proceed with a framework that will permit drugmakers to create and market lower-cost versions. So, at 8:30 am EST today, the FTC will conduct a workshop organized into five panels to discuss the following issues: the price and market share effect of entry by both biosimilar and biogeneric drugs, the likely competitive effects of reference product regulatory exclusivity, biotechnology patent issues, the likely competitive effects of follow-on biologic regulatory incentives, and the patent resolution process. The FTC, you may recall, wrote a lette... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1981289 Fri, 21 Nov 2008 12:22:29 +0100 1981289 http://www.medworm.com/index.php?rid=1943298&cid=t_169632_125_f&fid=34820&url=http%3A%2F%2Fwww.dentalblogs.com%2Farchives%2Fadministrator%2Fdentists-as-creditors-must-adhere-to-red-flag-rules-%25e2%2580%2593-compliance-delayed-six-months%2F The Federal Trade Commission (FTC), which regulates banks, and the National Credit Union Administration (NCUA) have delayed mandatory compliance with the Red Flag Rules for six months. Why should you care? As a dentist, if you extend or arrange to extend credit to any patient, you must comply with the Red Flag Rules. The purpose of the rules is to keep everyone safe from identity fraud/theft. Your dental practice will need to come up with a written program to identify the “red flags” of identity theft. According to the FTC website, “These may include, for example, unusual account activity, fraud alerts on a consumer report, or attempted use of suspicious account application documents. The program must also describe appropriate responses that would prevent and mitigate the... dental blog for dentists about dentistry blogs http://www.medworm.com/rss/comments.php?id=1943298 Fri, 07 Nov 2008 14:47:26 +0100 1943298 http://www.medworm.com/index.php?rid=1461247&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F295333252%2F Drugmakers win, consumers lose. That’s the message from the Federal Trade Commission, which released its latest annual report on the deals between brand-name and generic drugmakers. In fiscal year 2007, which ended September 30, 2007, there were 33 final settlements. Of those, 14, or 42 percent, included both compensation to the generic company and a restriction on the generic’s ability to market its product. Of those 14 settlements, 79 percent involved agreements with first-filer generic makers. Unlike the previous fiscal year, most of the agreements involving restrictions on generic entry did not include a side deal involving elements not directly related to the resolution of the patent dispute. Instead, the majority involved compensation to the generic firm through an agreemen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1461247 Wed, 21 May 2008 21:16:41 +0100 1461247 http://www.medworm.com/index.php?rid=1407333&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F280048592%2F Nice to see you again. As the rain moves away from the nation’s medicine chest, we have been scurrying to deposit short people at schools and gather items of interest. Now, we are settling down with our beloved cup of stimulation. So take a pause and join us. And best of luck today… Medco Profit Beats Wall Street Estimates (Yahoo/AP) FTC’s Cephalon Suit Moved To State Court (Yahoo/Reuters) Fosamax Linked To Atrial Fibrillation - Again (Seattle Post-Intelligencer) Lundbeck Names Wyeth Exec As CEO (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1407333 Tue, 29 Apr 2008 12:08:49 +0100 1407333 http://www.medworm.com/index.php?rid=1373839&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F270658832%2F This looks like a win-win, at least for the drugmakers. For AstraZeneca, the deal means a generic version of its best-selling ulcer med, which racked up $5.2 billion in sales last year, won’t appear in pharmacies this week. That’s when a 30-month stay barring a generic would have expired. “The agreement allows us to spend more of our time and money in the laboratory and less in the courtroom,” says AstraZeneca ceo Dave Brennan, according to Bloomberg News. For Ranbaxy Laboratories, the deal offers different enticements - the Indian generic maker will become the US distributor for authorized generic versions of two other meds, Plendil and a 40 mg version of Prilosec, for which it will be compensated. Ranbaxy, which acknowledged all six AZ Nexium patents are valid and... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1373839 Tue, 15 Apr 2008 11:50:02 +0100 1373839 http://www.medworm.com/index.php?rid=1255191&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F240867149%2F Earlier this month, the US Federal Trade Commission filed a lawsuit accusing Cephalon of paying more than $200 million to four rivals for keeping generic versions of its Provigial sleep-disorder pill off the market. The move was the latest effort in a long-running battle by the agency to thwart settlements it labels costly to consumers. Brand-name drugmakers, however, say the deals make sense if patent litigation can be minimized. In an editorial in The Washington Post, Jon Leibowitz, one of five FTC commissioners, says the Cephalon case may land before the Supreme Court. Here is an excerpt… “Getting health-care costs under control is a daunting and multifaceted challenge. But one simple approach could save consumers billions of dollars annually: stopping pharmaceutical compani... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1255191 Mon, 25 Feb 2008 13:02:23 +0100 1255191 http://www.medworm.com/index.php?rid=1230422&cid=t_169632_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F234616823%2F The agency is challenging deals worth an estimated $200 million with Barr Labs, Ranbaxy Labs, Mylan Labs and Teva to keep a generic version of the Provigil sleep-disorder pill off the market until 2012. In its suit, the FTC asks the US District Court for the District of Columbia to void the agreements, essentially giving the generic drugmakers a green light to start selling their low-priced copycats. The FTC contends Cephalon took that step because Provigil is such an important product - the pill generated $800 million last year, or 40 percent of sales. “The prospect of generic competition was a major financial threat to the company,” according to the FTC, which called the payments “purportedly independent business transactions.” But as a result, Cephalon forced pat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1230422 Wed, 13 Feb 2008 22:45:04 +0100 1230422