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 'henry waxman'. Sat, 03 Sep 2011 02:20:49 +0100 http://www.medworm.com/index.php?rid=4313987&cid=t_124386_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FLOu1IAoxepY%2F By Walter OlsonWhile others wish the new Congress well today on its swearing-in, I plan to light a 100-watt incandescent bulb and hoist a caffeinated alcoholic beverage in honor of a different milestone: starting today, the powerful House Energy and Commerce Committee will no longer be under the control of Henry Waxman (D-Calif.). Some lawmakers can talk a decent game about lean ‘n’ smart regulation, but no one ever accused Waxman of having a light touch. (The 900-page Waxman-Markey environmental bill, mercifully killed by the Senate, included provisions letting Washington rewrite local building codes.) He’s known for aggressive micromanagement even of agencies run by putative allies: his staff has repeatedly twisted the ears of Obamanaut appointees to complain that their... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4313987 Wed, 05 Jan 2011 19:30:34 +0100 4313987 http://www.medworm.com/index.php?rid=4277958&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxWGxZrIn9t4%2F As promised, a handful of House Democrats have introduced legislation that would increase funding and authority for the FDA to monitor drug production - both domestically and overseas - in hopes of improving safety in the wake of the Heparin scandal and other recent episodes that questioned foreign production of meds sold in the US. The bill would crreate an up-to-date registry of all domestic and foreign facilities serving the US; generate funding for increased Good Manufacturing Practices (GMP) inspections for brand and generic drugs; require parity between foreign and domestic inspections; prohibit entry of drugs coming from domestic and foreign facilities that limit, delay or deny FDA inspections; prohibit drugs from entering the US if safety documentation is lacking; requires manufact... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4277958 Tue, 21 Dec 2010 14:38:54 +0100 4277958 http://www.medworm.com/index.php?rid=4225251&cid=t_124386_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fpregnancy-as-a-pre-existing-condition%2F2010.12.03 Women who own individual healthcare policies, please take note. Should you become pregnant in the future, your individual healthcare policy might not cover your pregnancy. A recent article in the Los Angeles Times by Michelle Andrews was revealing. Andrews described the plight of a North Carolina biology teacher who subsequently left teaching after the birth of her twins. She became a small business owner and was covered under individual health insurance policies. However, when she became pregnant again, she had a rude awakening. Despite paying an insurance premium of $400 per month, her pregnancy wasn’t covered unless she had paid for a special rider, prior to becoming pregnant. Since half of all pregnancies are “unplanned” how can you pay for coverage six months in advance of an u... Better Health blogs http://www.medworm.com/rss/comments.php?id=4225251 Fri, 03 Dec 2010 13:00:20 +0100 4225251 http://www.medworm.com/index.php?rid=3987234&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaWze7AH3p9A%2F For the past three years, Paul Thacker was an investigator on the US Senate Finance Committee, working for Iowa Republican Chuck Grassley, who is the ranking minority member. During his tenure, Thacker was central to probes into the pharmaceutical industry, specifically, investigations into the disclosure of clinical trial data for GlaxoSmithKline’s Avandia diabetes pill and undisclosed financial conflicts of interest among academic researchers. Earlier this month, the former US Army specialist left to join a non-profit watchdog, the Project on Government Oversight. We caught him as we walked out the door to ask about his efforts and whether he thought the probes created any change. Pharmalot: Why leave now? Thacker: I’ve been on the committee for three years and two years is cons... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3987234 Mon, 20 Sep 2010 13:37:49 +0100 3987234 http://www.medworm.com/index.php?rid=3915286&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FP96r1KXl_cQ%2F Just how useful are non-inferiority trials? For the uninitiated, such trials compare a drug being developed with one that is already approved by the FDA. Drugmakers, of course, pursue such studies so they can show their new med is no worse than another, and may even show some benefits. But this approach has generated criticism - why approve a new drug when an existing med does the job? There is also concern about ‘biocreep.’ This refers to concerns that successive generations of drugs that are approved based on non-inferiority trials can lead to less effective drugs over time, including those that are, ultimately, no more effective than a placebo. And so after a request from several members of Congress, the General Accountability Office has issued a new report that indicates th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3915286 Mon, 30 Aug 2010 13:28:47 +0100 3915286 http://www.medworm.com/index.php?rid=3590449&cid=t_124386_131_f&fid=35743&url=http%3A%2F%2Fthegenesherpa.blogspot.com%2F2010%2F05%2Fthomas-goetz-has-wrong-debate-fda.html I think everyone in this space has been way off base as to what the problem is with FDA and Congress wanting to investigate the DTC Genomics companies. The whole mindset is wrong. What I hear from this debate is "It's my data, mine, mine, mine. Gimmee, Gimmee, you can't keep me from my data Big Brother!"From Mr Goetz's Blog"The controversy seems to have stirred the FDA to assert its authority – and that of physicians – over any and all medical metrics." "To me, getting access to this information is a civil rights issue. It’s our data." This is a straw man argument that has been set up to make regulating these companies seem unseemly and an invasion of privacy. IT IS A DEAD WRONG ARGUMENT and I will not stand for it being perpetuated anymore. This is not about getting access to your d... Gene Sherpas: Personalized Medicine and You blogs http://www.medworm.com/rss/comments.php?id=3590449 Sat, 22 May 2010 18:49:00 +0100 3590449 http://www.medworm.com/index.php?rid=3526946&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzpqIM4B9T1U%2F Access to medicines in poor and developing countries remains a hot issue and the outcome can often be influenced by trade policies. For this reason, the annual report from the US Trade Representative is closely watched for signs that public policy strikes an even balance between basic human needs and the economic interests, notably patents, of key US industries, including the pharmaceutical industry. This time around, the US Trade Rep’s annual report (which you can read here) notes that the US affirms the conclusions of the Doha declaration of TRIPS, the trade-related aspects of intellectual property rights (see this primer), and “respects a country’s right to protect public health and, in particular, to promote access to medicines for all, and supports the vital role of the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3526946 Mon, 03 May 2010 15:24:09 +0100 3526946 http://www.medworm.com/index.php?rid=3437687&cid=t_124386_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2Fb8CYp1Pk3xA%2F By David BoazGlenn Reynolds, a law professor at the University of Tennessee but better known as Instapundit, writes in the Washington Examiner that the controversy over big corporations’ reporting the impact of the new health care legislation on their tax bills illustrates the “Knowledge Problem” identified by Nobel laureate F. A. Hayek in “The Use of Knowledge in Society” and other writings. Hayek pointed out that the information needed to run an economy doesn’t exist in any one database or agency. It is scattered among millions of people and made available to others by means of the price system. Planning and regulation do away with the information embodied in prices and try to improve on market outcomes by making use of far less information. Reynolds wr... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3437687 Sun, 04 Apr 2010 22:21:52 +0100 3437687 http://www.medworm.com/index.php?rid=3420757&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNU_v5klsnPs%2F Lo, and the Lord sayeth to the Spinmeister: ‘Let My Pharmalot Go!’ But the Spinmeister was a cunning strategist and spoke out of both sides of his mouth. And still he enslaved poor Pharmalot. And so the Lord visited excruciating plagues upon the Spinmeister: Steve Nissen; Henry Waxman; Margaret Hamburg; Harlan Krumholz; Chuck Grassley; Catherine D’Angelis; Michael Loucks; Sid Wolfe; Jon Leibowitz and Jamie Love. Yet, the Spinmeister would not relent, and so the Lord slayed the compensation prince in each House of Pills. And finally, the Spinmeister released poor Pharmalot, who took his magic laptop and then wandered the Short Hills of the Garden State in search of the Promised Truth. But lo, the Spinmeister sent his army of flaks after poor Pharmalot. A mighty babble was heard a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3420757 Mon, 29 Mar 2010 20:32:03 +0100 3420757 http://www.medworm.com/index.php?rid=3178985&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDPiZK0lyD2I%2F What a difference a few years can make. Drugmakers want a provision of the healthcare reform legislation, which offers 12 years of exclusivity, to remain intact because it offers market exclusivity by delaying lower-cost competiton. However, the White House and Henry Waxman, who chairs the House Energy & Commerce Committee, are jockeying to lower that to anywhere from seven to 10 years, the Associated Press writes. And so the industry is threatening to bolt. In an e-mail obtained by the AP, PhRMA told its board members that “we could not support the bill” if the industry is given less than 12 years of competitive protection for the expensive products. “Please activate immediately all of your contacts,” said the e-mail from Billy Tauzin, the group’s presid... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3178985 Sat, 16 Jan 2010 15:37:54 +0100 3178985 http://www.medworm.com/index.php?rid=2522819&cid=t_124386_87_f&fid=38368&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2FPXIMAhh8eyM%2F The Top headline of FDA News Device Daily today read, “Comparative Effectiveness Research has Benefits, Risks Experts Say”. Why would Device Daily consider comparative effectiveness to be risky? Many obvious concerns come to mind. There are distinct risks that the process imposed on the device industry may stifle growth. Worries abound related to the direction policy makers may employ such as when studies will be required (e.g., at the early stages of development, or later in the cycle of real-world experience), how studies will be conducted (e.g., by the government or a public/private entity), who will determine the type, scope, design and rationale for conducting such studies, what the studies will be used for (e.g., to restrict coverage, to control access). The medical device indus... Disruptive Women in Health Care blogs http://www.medworm.com/rss/comments.php?id=2522819 Fri, 26 Jun 2009 14:02:33 +0100 2522819 http://www.medworm.com/index.php?rid=2027783&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F479449838%2F Henry Waxman, the California Democrat who will soon head the House Energy & Commerce Commitee, wants to give the FDA the power to ban direct-to-consumer ads when a new medicine first reaches the market and risks are not fully known, Reuters writes. The idea is one of several he hopes to pursue come January after a new Congress convenes, he told an industry conference yesterday. “It is in these first few years of a drug’s life that drug companies often aggressively market their products and engage in direct-to-consumer advertising. This increases the number of consumers exposed to safety risks of new products long before those risks are truly understood,” Waxman said at a conference sponsored by The Prescription Project, a group critical of industry marketing. He supp... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2027783 Tue, 09 Dec 2008 11:34:33 +0100 2027783 http://www.medworm.com/index.php?rid=1985168&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F463878507%2F The consensus last week was that the upcoming change at House Energy & Commerce Committee, where California Democrat Henry Waxman will replace Michigan Democrat John Dingell, is something of a wash for pharma and the FDA. That’s because both men were known to be tough on drugmakers and regulators alike, and have launched numerous investigations into pricing, marketing and safety issues. But it may not be that simple, at least in the short run. The changeover, which made for compelling intrigue on Capitol Hill, may actually cause efforts already under way by the House Committee on Oversight and Government Reform to languish. Among the topics it explored: Glaxo’s Avandia diabetes pill, FDA enforcement, preemption and Medicare Part D pricing. In fact, whether the committee co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1985168 Mon, 24 Nov 2008 13:23:10 +0100 1985168 http://www.medworm.com/index.php?rid=1975634&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F459737779%2F The final vote was 137-122 in favor of Henry Waxman, who currently chairs the House Government Oversight and Reform Committee and is closely allied with House Speaker Nancy Pelosi. The outcome is not a huge surprise, though, given that the California Democrat won a key preliminary vote yesterday. On Capitol Hill, the change is viewed as a referendum on the Democratic Party’s approach to energy policy, given that John Dingell is from Michigan and fiercely defends automakers. Waxman backs clean-air initiatives. The affect on pharma remains unclear. Both Waxman, 69, and Dingell, 82, who served as the House Energy & Commerce Committee’s top Democrat since 1981, have been tough on drugmakers. (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1975634 Thu, 20 Nov 2008 16:34:18 +0100 1975634 http://www.medworm.com/index.php?rid=1975637&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F459503259%2F A spokeswoman for Henry Waxman says the California Democrat has been selected by a key leadership panel to replace veteran Chairman John Dingell as head of the House Energy & Commerce Committee, which has jurisdiction over the FDA. This is only a preliminary round, though. Waxman, 69, and the 82-year-old Dingell, who has served as the committee’s top Democrat for 28 years, will square off today in a vote of rank-and-file House Democrats. But based on a 25-22 vote in the leadership panel yesterda, Waxman has to be considered the favorite to topple Dingell, the longest serving House member. Waxman, who chairs the House Government Reform and Oversight Committee, is just as likely to scrutinize pharma, given his track record, which includes railing against preemption; chastising the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1975637 Thu, 20 Nov 2008 12:13:58 +0100 1975637 http://www.medworm.com/index.php?rid=1947488&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F448466659%2F Usually, Henry Waxman (pictured left) and John Dingell expend their energy berating pharma or some other industry for alleged bad behavior. Now, though, the two seasoned pols are fighting one another over leadership of the House Energy & Commerce Committee, which Dingell, a Michigan Democrat, currently chairs. Waxman, who is the second-ranking Democrat on the E&C committee, chairs the House Government Reform and Oversight Committee, which isn’t as powerful and will probably not be as sexy now that a Democrat will again occupy the White House, The Wall Street Journal notes. So last week, Waxman, 69, sent a letter to House Democrats seeking support, writing that, while he admires Dingell, the 82-year-old lawmaker will have served as the E&C committee’s top Democrat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1947488 Mon, 10 Nov 2008 14:49:05 +0100 1947488 http://www.medworm.com/index.php?rid=1926678&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F438208230%2F The drugmaker this morning hand-delivered a letter to the Supreme Court responding to the report released two days ago by the House Committee on Oversight and Government Reform, which is chaired by California Democrat Henry Waxman (back story). And Wyeth, essentially, tells the court that the report should be dismissed, citing these reasons… First, the report is entitled to no ‘persuasive weight,’ because it was written only by the majority committee staff and was not adopted by any full committee. Next, the report actually supports Wyeth’s position about the meaning of the ‘change being effected,’ or CBE labeling regulation, which restricts the ability of drugmakers to disclose new safety risks without prior FDA approval. And finally, Wyeth asserts the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1926678 Fri, 31 Oct 2008 16:37:17 +0100 1926678 http://www.medworm.com/index.php?rid=1806485&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F395374696%2F Henry Waxman continues to have his suspicions about the FDA. In a letter today to FDA Commish Andy von Eschenbach (pictured to the left) after receiving internal FDA e-mails about agency decisions over the couple of years. His conclusion? “Political appointees at the agency may be promoting industry priorities at the expense of FDA’s core public health mission,” according to Waxman. For instance, there was an e-mail dated June 15, 2007 from Sheldon Bradshaw, who was then FDA chief counsel to Scott Danzis, who was then Bradshaw’s special assistant. Bradshaw asks Danzis to provide a list of “the guidances/regulations you are working on or would like to work on.” Bradshaw goes on to write: “I’ll send that list to the Deputy Secretary who, in turn, will send it ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1806485 Wed, 17 Sep 2008 17:16:51 +0100 1806485 http://www.medworm.com/index.php?rid=1671778&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F351607267%2F In an effort to dilute the impact of sales reps, several Senators and Congressmen today are introducing a bill that would create funding for a program to send trained pharmacists, nurses, and other health care professionals into a doctor’s office with independent data about benefits, risks, costs, and comparative effectiveness of prescription drugs, including generics. The Independent Drug Education and Outreach Act of 2008 would make it possible to fund grants or contracts through the HHS Agency for Health Care Research and Quality to develop educational materials and to send trained medical professionals to a doc’s office to discuss “unbiased information on appropriate prescribing,” according to a summary of the bill. (Here is the Senate version.) Applicants may n... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1671778 Thu, 31 Jul 2008 14:48:52 +0100 1671778 http://www.medworm.com/index.php?rid=1546981&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F320711109%2F As promised, two Democratic Congressmen have introduced the Medical Device Safety Act of 2008, which they claim will protect patients from dangerous and defective devices by explicitingly stating that FDA regulation does not trump the ability of consumers to seek damages under state law. You may recall that, last February, the US Supreme Court ruled in Riegel v. Medtronic that patients injured by defective devices can’t sue for damages in state courts if the FDA approved the marketing of the product. The court decided the 1976 Medical Devices Amendment preempted the right of patients to sue for damages in state courts over devices that receive premarket FDA approval. “This decision ignores both congressional intent and 30 years of experience in which FDA regulation and tort liabili... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1546981 Thu, 26 Jun 2008 18:24:06 +0100 1546981 http://www.medworm.com/index.php?rid=1440011&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F289358496%2F A seemingly arcane legal concept is quickly gaining a great deal of attention - and for good reason. At issue is the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining agency actions are the final word on safety and effectiveness. This fall, the Supreme Court will hear a case - which involves a Wyeth drug (here’s the back story) - and the ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. To get in front of the issue, the House Committee on Oversight and Government Reform will explore the debate. The witness includes some marquee names - actor Dennis Quaid, who is suing Baxter; former FDA commish Davi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1440011 Tue, 13 May 2008 11:00:39 +0100 1440011 http://www.medworm.com/index.php?rid=1309054&cid=t_124386_135_f&fid=35262&url=http%3A%2F%2Fsurvivinghiv.blogspot.com%2F2008%2F03%2Fimportant-information-about-nandrolone.html QUESTION FROM SOMEONE IN MY POZHEALTH AT YAHOOGROUPS.COM LIST:"I interpret this that once the current supply of the components tomake nandrolone are depleted, there will be no more access tonandrolone here in the US. Am I right or just the number ofcompounding pharmacies may continue to dwindle due to DEA pressures?Thanks everyone,Tom A"MY ANSWER:Dear TomThe ingredients to make nandrolone are not depleted. The decision from the manufacturer (Watson) to stop making nandrolone decanoate (an effective injectable medicine to treat unintentional weight loss and to increase muscle mass) was based on economics and political pressure.Watson stopped making it because:1- It is a generic CHEAP drug2- They can sell expensive Oxandrin instead. Oxandrin is approved for unintentional weight loss but cost... Nelson Vergel's HIV Blog blogs http://www.medworm.com/rss/comments.php?id=1309054 Mon, 17 Mar 2008 21:52:00 +0100 1309054 http://www.medworm.com/index.php?rid=1063012&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F193136270%2F The chairman of the House Oversight and Government Reform committee is concerned that a new FDA draft guidance about distributing journal articles will open the door to promote “potentially dangerous uses” of drugs and devices without prior FDA review and approval. The forthcoming guidance, which you can see here, represents FDA thinking on the publication and dissemination of studies on unapproved new uses of approved drugs and devices. The topic gained attention several years ago as a commercial free speech issue, and in the guidance, the FDA writes that “the public health may be advanced by healthcare professional’s receipt of medical journal articles and medical or scientific reference publications on unapproved or new uses of approved or cleared medical product... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1063012 Fri, 30 Nov 2007 20:22:33 +0100 1063012 http://www.medworm.com/index.php?rid=952288&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F170239363%2F That’s what staffers from a Democratic House panel conclude in a new report. US taxpayers and Medicare patients could have saved almost $15 billion this year if private health insurers had cut expenses for prescription drug coverage and negotiated bigger discounts, according to the report released today by the House Oversight and Government Reform Committee. The Medicare Part D benefits offered by private insurers operate with “high administrative costs, sales expenses and profits,” the report said. The conclusions were based on proprietary cost and pricing data obtained from 12 insurers that provide drug coverage to more than 18 million Medicare patients, Reuters writes. “The cost and pricing data obtained by the committee reveal that use of private insurers to del... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=952288 Mon, 15 Oct 2007 17:37:27 +0100 952288 http://www.medworm.com/index.php?rid=931295&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F165892827%2F The California Democrat, who chairs the Committee on Oversight and Government Reform in Congress, is asking OTC makers to voluntarily relabel their products with a warning not to give the drugs to anyone under 2 years old, the Associated Press reports. Although Waxman stopped short of asking the FDA to mandate an immediate label change, he did send a letter this week to a trade group representing Novartis, Johnson & Johnson and Procter & Gamble, among others, asking for voluntary label revisions. His letter comes not long after the FDA made a nonbinding recommendation that the drugs shouldn’t be taken by very young children. Current labeling directs parents to consult a doctor before administering the drugs to infants and toddlers and many doctors say they are safe to use, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=931295 Fri, 05 Oct 2007 21:25:58 +0100 931295 http://www.medworm.com/index.php?rid=848530&cid=t_124386_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F153411914%2F Lawmakers are unlikely to add generic biologics legislation to an FDA bill that’s expected to receive congressional approval this month, two key U.S. congressmen said on Thursday, reports Reuters. Generic drugmakers have been pushing legislation that would chart a specific path for the FDA to approve cheaper copycat versions of biotech meds. The chances of adding the generic biologics measure to a broad FDA bill now moving through Congress are “extremely slim,” Rep. Henry Waxman, a California Democrat, told a Generic Pharmaceutical Association conference. Rep. Frank Pallone, a New Jersey Democrat, also said it was unlikely that House and Senate negotiators could agree on an approach for generic biologics in time to include it in the FDA bill. The FDA legislation, which i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=848530 Fri, 07 Sep 2007 11:44:42 +0100 848530