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 'hamburg'. Sat, 03 Sep 2011 02:55:58 +0100 http://www.medworm.com/index.php?rid=5097093&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FB_rma9edmls%2F Last week, FDA commish Margaret Hamburg told a congressional committee that the agency may loosen conflict of interest rules that were enacted in 2008, because finding qualified experts to serve on advisory committees has become increasingly difficult (back story here). Her remarks parroted a point made three months ago by Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, who has been pushing to relax the rules, which include barring participation for any individual who has potentially conflicting financial interests totaling more than $50,000 ( you can read more here). Last year, the agency tweaked its procedures for granting waivers (see this). The effort by FDA officials to roll back the rules, which were passed after an arduous campaign to promote greater ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5097093 Thu, 04 Aug 2011 14:37:45 +0100 5097093 http://www.medworm.com/index.php?rid=5029212&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F48ruNb0tqKc%2F Six months after reviewing her operations, FDA commish Margaret Hamburg has made good on reorganizing the workload and responsibilities by hiring an outsider as a deputy commish and promoting an agency stalwart to a different deputy commish slot. The overhaul was also undertaken at the time that former deputy commish Josh Sharfstein - a close Hamburg ally - departed from the agency after less than two years on the job (see here). And so, former Dartmouth University Medical School Dean Stephen Spielberg was named to the newly created position of deputy commissioner for medical products and tobacco, while Deborah Autor, an attorney who now is director of the Center for Drug Evaluation & Research, to deputy commish for global regulatory operations and policy. “The structure of the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5029212 Thu, 14 Jul 2011 14:06:08 +0100 5029212 http://www.medworm.com/index.php?rid=4853217&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZdvfQlG4ejw%2F The ‘phantom recall’ scandal last year in which Johnson & Johnson hired contractors to yank over-the-counter meds such as Motrin from store shelves rather than conduct a proper recall prompted congressional hearings and contributed to a consent decree, among many other things. And during one hearing, the FDA agreed to review procedures that allowed the health care giant to, essentially, circumvent agency oversight (back stories here, here and here). Now, though, Darrell Issa, who chairs the House Committee on Oversight and Government Reform, which held those hearings, has written FDA commish Margaret Hamburg to say the agency has failed to take “promised and necessary corrective actions at its San Juan office.” And he complains that he encountered “great ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4853217 Mon, 23 May 2011 18:19:57 +0100 4853217 http://www.medworm.com/index.php?rid=4715019&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWxRg5kRjTGc%2F Once again, several House Democrats have introduced a bill designed to increase funding and authority for the FDA to monitor drug production. The latest legislation, however, is aimed specifically at foreign-made pharmaceuticals, given ongoing concerns about the supply chain amid several episodes that questioned foreign production of meds sold in the US. The new bill, which is called the Drug Safety Enhancement Act and was sponsored by John Dingell, a Michigan Democrat, and three of his colleagues, would provide added funding to the FDA to inspect drugs imported into the US, increase civil and criminal penalties, and increase agency inspection of overseas manufacturing to the same level of scrutiny applied to domestic facilities (to read the bill, please go here and type in HR 1483). &#822... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4715019 Thu, 14 Apr 2011 15:18:38 +0100 4715019 http://www.medworm.com/index.php?rid=4522288&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9JI7t-4bhHU%2F Last month, FDA device chief Jeff Shuren committed a diplomatic faux pas. While speaking with reporters about varying approval standards and safety issues in the US and Europe, he quoted a surgeon who supposedly said “under the EU system, the public are being used as guinea pigs.” And then he added his own two cents by saying that “we don’t use our people as guinea pigs in the US.” Not surprisingly, someone in Europe has taken exception - Paola Testori Coggi, the European Commission’s Directorate-General for Health and Consumers, wrote a letter to FDA commish Margaret Hamburg to complain. “I am deeply concerned that a senior official of the FDA should publicly discredit the regulatory system in Europe in this way,” Coggi wrote in the Feb. 18 ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4522288 Fri, 25 Feb 2011 13:56:19 +0100 4522288 http://www.medworm.com/index.php?rid=4512610&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F01Pd_tGjLqE%2F Three years after the FDA linked the Heparin scandal to contaminated supplies from China, a Congressional committee has lashed out at the agency for failing to find the culprits behind the episode and has now written FDA commish Margaret Hamburg to release all documents related to the agency investigation. You may recall that contaminated heparin made in China was linked to 81 deaths in 2007 and 2008 (back story), and the episode sparked a firestorm of criticism at the FDA for its failure to monitor medicines made there (background). “There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the (United States),&#8... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4512610 Thu, 24 Feb 2011 00:14:19 +0100 4512610 http://www.medworm.com/index.php?rid=4309849&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FscX860r0VQs%2F After less than two years on the job, FDA deputy commish Josh Sharfstein is leaving the agency to become the secretary of health and mental hygiene in Maryland, according to reports. His departure comes as the FDA is in the midst of grappling with a host of far-reaching safety and enforcement initiatives that he came, in part, to symbolize. The departure was tweeted by Congressional Quarterly’s Healthbeat last night and an FDA spokeswoman would only say that she couldn’t confirm anything. This morning, The Wall Street Journal cites unnamed government sources, as well as a spokesman for Maryland Governor Martin O’Malley who tells the paper an announcment about the post is expected tomorrow. Before arriving at the agency to work with FDA commish Margaret Hamburg, Sharfstein... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4309849 Tue, 04 Jan 2011 17:57:50 +0100 4309849 http://www.medworm.com/index.php?rid=4305105&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F---sJ6wFY7c%2F This is hardly surprising. Given the ongoing talk at the FDA about placing greater emphasis on safety, no one should be shocked that the pace of drug approvals remains modest. Last year, 21 new drugs were approved, down from 25 in 2009 and 24 in 2008. However, the latest tally is actually higher than the 18 approvals issued in 2007. As The Wall Street Journal notes, the latest approvals included a few biologics that are expected to become sizeable sellers: Amgen won approval for Prolia, which is used to treat osteoporosis in postmenopausal women; Roche’s Genentech scored with Actemra for rheumatoid arthritis; Boehringer Ingelheim received approval for Pradaxa, a new type of bloodthinner and Novartis garnered FDA endorsement for its Gilenya multiple sclerosis pill. And how can anyone ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4305105 Mon, 03 Jan 2011 13:02:45 +0100 4305105 http://www.medworm.com/index.php?rid=4152272&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyEol_ZBMUqs%2F Good morning, folks. How are you today? We are just fine, thank you. After all, the sun is shining here on the Pharmalot corporate campus, where the official mascots are chasing squirrels and two cups of stimulation are brewing. What will today bring? Hmm… One never knows, but to help you prepare, we have gathered a few interesting tidbits of information. So dig in. And we hope your day goes well… PhRMA CEO John Castellani On Elections And Health Care Reform (Politico) Merck Results For Cholesterol Pill Are Due Next Week (Bloomberg News) FDA Commish Defends Handling Of Heparin Crisis (Reuters) Glaxo Sees More Industry Consolidation (The Business Standard) Pharma Needs Lessons On Winning Trust (MedAd News) Court Is Urged To Narrow Patent-Misconduct Standard (Bloomberg News) FDA ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4152272 Wed, 10 Nov 2010 12:39:39 +0100 4152272 http://www.medworm.com/index.php?rid=4098462&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FofgMWGHYZdw%2F Today is the day that countless people - from the overweight to those overweighted in Arena Pharmaceutical stock - may learn whether the FDA will approve the drugmaker’s diet pill. Not every agency deadline is so closely watched, but this one is generating enormous attention for two reasons - diet pills have not fared well despite the rising rate of obesity and an unusual push by angry investors who believe the FDA unfairly reviewed the drug - which we were the first to report (see this). Last month, you may recall, an FDA advisory committee voted 9-to-5 that the risks of the Lorqess diet drug developed by Arena outweighed the benefits. The decision came after concerns about valvulopathy and, in particular, links to malignancies in rats at higher doses, which were revealed in FDA bri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4098462 Fri, 22 Oct 2010 12:57:50 +0100 4098462 http://www.medworm.com/index.php?rid=3999297&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fn-1LdL79IQo%2F Without question, the three-year long controversy over the GlaxoSmithKline Avandia diabetes pill has stirred passions. The debate has centered on a host of issues that have helped define the pharmaceutical industry, as well as the FDA - drug safety, the disclosure of clinical trial data, the relationships between pharma and doctors, and the ability of regulators to regulate. And so today, the FDA, more or less, struck a mid-ground: instead of withdrawing Avandia altogether or leaving it alone, the agency played Solomon and decided to continue to make the drug available but with significant restrictions on accessibility to patients (please our post here for more detail). The choice roughly mirrored what an FDA advisory panel voted to recommend last July. Meanwhile, the European Medicines Ag... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3999297 Thu, 23 Sep 2010 16:48:47 +0100 3999297 http://www.medworm.com/index.php?rid=3994340&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FI6DiTjJuE00%2F That’s right, folks. The FDA has scheduled an 11:30 am EST confernce call with FDA commish Margaret Hamburg to announced the eagerly awaited decision about what to do with the controversial Avandia diabetes pill sold by GlaxoSmithKline. A majority of FDA advisory panelists, you may recall, two months ago recommended the drug remain available, but with varying restrictions (look here). What’s also interesting is that the European Medicines Agency, which has spent much of this week reviewing Avandia, is also set to announce its decision at the same time. Such coordination is unusual and underscores the extent that regulators are becoming increasingly sensitive to safety issues and what critics say is a greater need for a more uniform approach to regulatory guidance. A quick remin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3994340 Thu, 23 Sep 2010 13:48:52 +0100 3994340 http://www.medworm.com/index.php?rid=3865462&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fq2qUgAD-wQM%2F Well, what do you expect Margaret Hamburg to say? There she is in Shanghai, touring some facility with Chinese government officials who, of course, will do their best to make sure she doesn’t catch a whiff of a contaminated active ingredient or come within 100 miles of a gray market supplier. And there is international diplomacy to consider, after all - who buys all that US government debt? Despite being labeled a paper tiger by a pair of Congressman who are angry over the lack of progress into the Heparin probe (see here), the FDA commish was all smiles as she explained her view of the relationship between her agency and its Chinese equivalent. “I leave feeling very encouraged by the partnership we’ve developed here,” Hamburg tells the Associated Press. “This... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3865462 Fri, 13 Aug 2010 11:59:18 +0100 3865462 http://www.medworm.com/index.php?rid=3767313&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPUVgYH4kPPo%2F Last year, a 7-year-old foster boy named Gabriel Myers committed suicide in Florida and, after reams of publicity and hand-wringing over the use of psychotropic medications in such children, a state task force recommended, among other things, that children never be allowed to participate in a clinical trial designed to evaluate new psychotropic meds or whether such drugs approved for adults should be given to children. The move was prompted, in part, because a Florida psychiatrist, Sohail Punjwani, who treated the boy before he committed suicide, received an FDA warning letter for failing “to protect the rights, safety and welfare” of children enrolled in clinical trials (back story). Before the suicide, the psychiatrist prescribed to kids several drugs, some of which weren’t approve... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3767313 Mon, 19 Jul 2010 13:56:21 +0100 3767313 http://www.medworm.com/index.php?rid=3746986&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-CbIiY0mVwQ%2F This report could change the Avandia game entirely. For one, if Marciniak’s view is widely held at the FDA (or it’s widely shared among its advisory committee), then we no longer have a case in which the clinical trials point one way and the observational evidence points the other way. More important, because Marciniak is a CDER reviewer, we no longer have a case in which the FDA’s ‘trialists’ are entirely at odds with its ‘observationalists.’ In other words, Marciniak’s memo may create doubt among many CDER medical reviewers who favor randomized clinical trials but who may come to doubt GSK’s credibility in running them. That kind of loss of trust can be severely destructive for a company. As far as I can tell, Marciniak’s voice is a new one in this debate, and combine... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3746986 Mon, 12 Jul 2010 13:09:05 +0100 3746986 http://www.medworm.com/index.php?rid=3740822&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiDRrKRR2FKU%2F With more than a thousand pages of memos, charts and studies decipher, there are all sorts of hints, allegations and conclusions to be found in the vast treasure trove that is the set of Avandia briefing documents posted on the FDA web site this morning. For those of you with time on your hand or skin in the game, feel free to get started here and here and here. You can read about the panel members below. The meeting, of course, is a litmus test for the FDA which, under commish Margaret Hamburg, is trying to brand itself as a public health agency. With that in mind, In a briefing for the media yesterday, FDA deputy commish Josh Sharfstein maintained “we’ll make decisions in the best interest of the public” when it comes to whether Avandia is withdrawn or allowed to remain... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3740822 Fri, 09 Jul 2010 19:13:50 +0100 3740822 http://www.medworm.com/index.php?rid=3746990&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLa0s0ITMqyY%2F What are the ethical issues the FDA faces when requiring a drugmaker to run a randomized clinical trial for an approved drug when a safety issue exists? The agency is confronting this dilemma as it evaluates the Avandia diabetes pill, which was linked to heart attacks and strokes in two large observational studies (see here and here) and will be the subject of a contentious FDA advisory committee meeting next week. To gain some guidance and political cover, FDA commish Margaret Hamburg recently asked an Institute of Medicine committee to explore this question - and four others concerning ethical and scientific issues in studying approved drugs, which will be answered in a more detailed analysis next spring. Given the Avandia debate, Glaxo is having trouble recruiting patients (see this). S... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3746990 Fri, 09 Jul 2010 13:55:06 +0100 3746990 http://www.medworm.com/index.php?rid=3740823&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLa0s0ITMqyY%2F What are the ethical issues the FDA faces when requiring a drugmaker to run a randomized clinical trial for an approved drug when a safety issue exists? The agency is confronting this dilemma as it evaluates the Avandia diabetes pill, which was linked to heart attacks and strokes in two large observational studies (see here and here) and will be the subject of a contentious FDA advisory committee meeting next week. To gain some guidance and political cover, FDA commish Margaret Hamburg recently asked an Institute of Medicine committee to explore this question - and four others concerning ethical and scientific issues in studying approved drugs, which will be answered in a more detailed analysis next spring. Given the Avandia debate, Glaxo is having trouble recruiting patients (see this). S... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3740823 Fri, 09 Jul 2010 13:55:06 +0100 3740823 http://www.medworm.com/index.php?rid=3706994&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FennOAQ5bM08%2F Just three weeks before what is certain to be a tense FDA advisory committee meeting, the study showing the Avandia diabetes pill increases the the risk of stroke, heart failure and death compared with Takeda Pharmaceutical’s Actos has been peer-reviewed and published (see this). This is the same paper that was leaked to us earlier this month (see here) and now appears online at the Journal of the American Medical Association web site. The study, which evaluated data from 227,571 Medicare patients between 2006 and 2009 with an average of 74.4 years, found there 1,746 heart attacks, of which 21.7 percent fatal; 1,052 strokes and 7.3 percent fatal; 3,307 hospitalizations for heart failure, including 2.6 percent that were fatal; and 2,562 deaths for all causes. Although the analysis sh... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3706994 Mon, 28 Jun 2010 14:18:07 +0100 3706994 http://www.medworm.com/index.php?rid=3648798&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIMny61PkBdU%2F A new observational study comparing the controversial Avandia diabetes pill found an increased risk of various cardiovascular problems compared with Actos, a similar drug but one that hasn’t raised as many concerns. Yet one co-author, FDA reviewer David Graham, recently wrote top FDA officials over concerns that agency supervisors hadn’t given clearance for the study to be submitted for publication. (You can see Graham’s email to FDA commish Margaret Hamburg further down). The May 28 draft manuscript indicates the authors reviewed records of 227,571 Medicare patients with an average age of 74.4 years who were followed for up to three years after starting either of the two pills. The results - GlaxoSmithKline’s Avandia increased the risk of stroke by 27 percent; hear... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3648798 Thu, 10 Jun 2010 16:07:11 +0100 3648798 http://www.medworm.com/index.php?rid=3652693&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIMny61PkBdU%2F A new observational study comparing the controversial Avandia diabetes pill found an increased risk of various cardiovascular problems compared with Actos, a similar drug but one that hasn’t raised as many concerns. Yet one co-author, FDA reviewer David Graham, recently wrote top FDA officials over concerns that agency supervisors hadn’t given clearance for the study to be submitted for publication. (You can see Graham’s email to FDA commish Margaret Hamburg further down). The May 28 manuscript indicates the authors reviewed records of 227,571 Medicare patients with an average age of 74.4 years who were followed for up to three years after starting either of the two pills. The results - GlaxoSmithKline’s Avandia increased the risk of stroke by 27 percent; heart fail... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3652693 Thu, 10 Jun 2010 15:33:43 +0100 3652693 http://www.medworm.com/index.php?rid=3599742&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsKMljKVmmps%2F Just two days before the House holds a hearing into the unusually large number of products recalled by Johnson & Johnson, the Senate Health, Education, Labor and Pensions (HELP) Committee wrote the FDA in search of additional info concerning actions taken by both the agency and the health care giant. “I am especially concerned because so many of the drugs at issue in this recall were intended for infants and children,” Harkin (see photo) wrote in his letter to FDA commish Margaret Hamburg. He did not indicate, however, plans to hold a hearing. The House Committee on Oversight and Government Reform will question FDA deputy commish Josh Sharfstein and Colleen Giggins, who heads J&J’s global consumer business on Thursday (see this). J&J’s McNeil unit was ci... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3599742 Tue, 25 May 2010 17:03:36 +0100 3599742 http://www.medworm.com/index.php?rid=3589040&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FW8jvepkv9ss%2F Despite a request by a fellow committee member to postpone a hearing into the Johnson & Johnson recall scandal, House Committee on Oversight and Government Reform chair Edolphus Towns, a New York Democrat, is proceeding with plans to hold the session this coming Thursday, May 27. You may recall earlier this week that Darrell Issa, the committee’s ranking member and a California Republican, asked Towns for a postponement because J&J ceo Bill Weldon is unable to atttend - he underwent back surgery the other day - and the FDA, meanwhile, has not yet completed its inspections of McNeil Consumer Healthcare facilities. J&J’s McNeil unit was cited for quality-control problems that affected about 40 over-the-counter meds for infants and children, and failed to properly follo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3589040 Sat, 22 May 2010 15:16:52 +0100 3589040 http://www.medworm.com/index.php?rid=3577623&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjN_3H3gL_f0%2F In a bid to open a window into the way it does business, the FDA has released a Transparency Report containing 21 draft proposals for public disclosure policies. This is all part of the three-phase Transparency Initiative that was launched last year. The proposals cover such areas as adverse event reports; the docket management process; enforcement priorities and actions; import procedures; inspections; product applications; recalls and warning letters. At the end of the day, the FDA hopes this process will better explain agency decisions, provide more data to doctors and patients, “illuminate” enforcement efforts and support innovation for rare diseases. How so? If the FDA explains an abandoned application for an orphan drug could represent a significant therapeutic advance, t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3577623 Wed, 19 May 2010 14:24:47 +0100 3577623 http://www.medworm.com/index.php?rid=3577628&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FukOpWgOREO4%2F What caused all those product recalls by Johnson & Johnson? What, if anything, did the FDA do about it? The House Committee on Oversight and Government Reform wants to know. And so after inviting J&J ceo Bill Weldon to testify on May 27, an ‘invitation‘ was just extended to FDA commish Margaret Hamburg. The hearing will examine the circumstances surrounding J&J’s recall of more than 40 types of infant and children’s meds made by J&J’s McNeil Consumer Healthcare, including Tylenol, Motrin and Benadryl. The episode occurred just after the FDA cited J&J for its ongoing failure to follow up reports of musty smells emanating from some products (see here and here). The committee, of course, wants to know why J&J wasn’t forced to m... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3577628 Tue, 18 May 2010 22:52:10 +0100 3577628 http://www.medworm.com/index.php?rid=3508447&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcHEwkbD7WIg%2F Is the TIDE trial going to get derailed? The FDA is already considering whether the studyl, which compares GlaxoSmithKline’s Avandia with Takeda Pharmaceutical’s Actos, should continue over concerns that it may be unethical to compare a drug with known cardiac risks with what appears to be a safer alternative (see here). The deliberations occur in the run-up to an FDA advisory committee meeting in July to review Avandia and cardiac risks. Now, some physicians are telling heartwire that the trial, which is supposed to involve thousands of patients, should be stopped, in part because informed consent forms may not reflect the most up-to-date Avandia safety info, an issue that FDA commish Margaret Hamburg alluded to in a recent letter to US Senator Chuck Grassley, who is investiga... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3508447 Tue, 27 Apr 2010 12:43:50 +0100 3508447 http://www.medworm.com/index.php?rid=3494550&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZAyqYFm0i5k%2F This is long overdue. In a bid to appear transparent, the agency is issuing a draft guidance that would expand disclosure when a conflict of interest waiver is granted to individuals who participate in its advisory committee meetings. The expanded disclosure about waivers would occur prior to committee meetings. Specifically, the FDA proposes to post online the name of the company or institution associated with the financial interest along with the type of conflict of interest. Typically, the agency redacts or omits info so that the nature of any possible conflict is difficult if not impossible to ascertain. There are 49 committees, by the way, and some 600 participants. This doesn’t mean the FDA will turn its nose at all conflicts. In a letter to agency staff, FDA commish Margaret ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3494550 Thu, 22 Apr 2010 12:17:01 +0100 3494550 http://www.medworm.com/index.php?rid=3483117&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8YlODPoiDBY%2F The FDA may halt a safety study involving patients taking GlaxoSmithKline’s Avandia diabetes pill, which could also determine whether the drug stays on the market, The Wall Street Journal reports. You may recall recent studies tied the med to an increased risk of heart attacks, and in 2007, the FDA approved a trial comparing Avandia with Takeda Pharmaceutical’s Actos, which hasn’t generated the same degree of safety concerns. But some scientists say it is unethical to compare a drug with known cardiac risks with a seemingly safer alternative, and that Avandia should be pulled from the market. For several years, the FDA pooh-poohed these concerns, but has now called in the Institute of Medicine to review the ethics of head-to-head studies, according to the Journal. In a le... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3483117 Mon, 19 Apr 2010 12:35:24 +0100 3483117 http://www.medworm.com/index.php?rid=3420757&cid=t_237269_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=3335567&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPH9ZazU-oc0%2F A hearing on drug safety is scheduled for next Wed., March 10, and will be held by the House Energy & Commerce committee’s subcommittee on Health. And the featured speaker will be deputy FDA commish Josh Sharfstein, as well as other FDA folks, according to The Pink Sheet. No particular reason was cited, but the impetus for the hearing isn’t being attributed to Avandia. You may recall the GlaxoSmithKline diabetes pill was the subject of a recent Senate Finance Committee report that found internal dissent among FDA staffers over what to do about cardiovascular risks (see here). Importation, however, is expected to be on the agenda. The hearing will be held because the committee hasn’t had any public discussion of drug safety since the FDA Commissioner Margaret Hamburg... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3335567 Fri, 05 Mar 2010 15:00:57 +0100 3335567 http://www.medworm.com/index.php?rid=3318661&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F86kVWSFgk9g%2F The increasing cry for lower health care costs usually includes an emphasis on wider use of generic drugs, but some data from the FDA suggests it will take longer for US payers and consumers to reap the benefits because approval times are lagging - creating a large backlog of Abbreviated New Drug Applications. The median NDA approval time by the agency’s Office of Generic Drugs rose about five months – to 26.70 months – in fiscal year 2009 compared with 21.65 months in fiscal year 2008. Yet the number of ANDA’s received is remaining fairly steady - 766 in fiscal year 2005, 880 in fiscal year 2007 and 859 in fiscal year 2009. As a result, a backlog is festering - from 891 in fiscal year 2005 to 1,912 in fiscal year 2010, according to OGD data presented at the recent Generic ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3318661 Mon, 01 Mar 2010 12:18:32 +0100 3318661 http://www.medworm.com/index.php?rid=3254720&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFj9Iaoy_2CU%2F To do so, the agency will use a new screening system to expedite importation of real meds and help inspectors focus their efforts on “high risk” products. Currently, customs officials examine a sliver of the 20 million shipments that reach US ports each year and that most inspections occur randomly. The new web-based system is called Predict (Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting), and assigns a risk rating to drugs and other goods based on contents, supplier and point of origin. High risk imports are flagged for inspection, The Pink Sheet notes. You can watch a video here to see how things should work. “Up to 40 per cent of the drugs (US citizens) take are imported” and “up to 80 per cent of the active pharmaceutical ingredients in those drugs... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3254720 Tue, 09 Feb 2010 13:15:08 +0100 3254720 http://www.medworm.com/index.php?rid=3244047&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJpX7aiLNLRI%2F The behind-the-scenes battle continues to rage between the FDA and a determined group of patients and investors who have agitated for nearly three years for the agency to approve the Provenge prostate cancer vaccine. Known as Care To Live, they are appealing a federal court decision denying them access to FDA documents pertaining to a series of events two years ago in which the agency unexpectedly delayed approval despite the recommendation of its own advisory panel. The group alleges undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving Richard Pazdur, the head of the oncology drugs office. The FDA has been fighting the group’s request for documents that was filed under the Fre... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3244047 Fri, 05 Feb 2010 14:33:23 +0100 3244047 http://www.medworm.com/index.php?rid=3101062&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4ElM3c_A9fo%2F The recent Senate squabbling over whether cheaper imports from Canada and elsewhere should be allowed into the US was full of intrigue. Why, for instance, did President Barack Obama flip-flop on his oft-stated campaign remarks that imports should be allowed? Was it the $80 million deal that PhRMA cut on discounts that would help pay for health care reform legislation? Meanwhile, some questioned the sudden appearance of a letter from FDA commish Margaret Hamburg, who worried aloud that her agency couldn’t guarantee the safety of meds coming into the country. Byron Dorgan, the North Dakota Democrat who fought for the importation amendment, tells The Wall Street Journal that he thinks the White House drafted her letter. Ironically, more active pharmaceutical ingredients are coming from ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3101062 Fri, 18 Dec 2009 14:11:19 +0100 3101062 http://www.medworm.com/index.php?rid=3012633&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F33K1qeHctV0%2F A determined group of patients and investors who have agitated for more than two years for the FDA to approve the Provenge prostate cancer vaccine are pressing their case to obtain undisclosed agency documents. Known as Care To Live, they are appealing a federal court decision last year denying them access to FDA documents pertaining to a series of events two years ago in which the agency unexpectedly delayed approval despite the recommendation of its own advisory panel. The group alleges undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving Richard Pazdur, the head of the oncology drugs office. The FDA has been fighting the group’s request for documents that was filed unde... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3012633 Fri, 20 Nov 2009 14:19:20 +0100 3012633 http://www.medworm.com/index.php?rid=2905108&cid=t_237269_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPqRzyV1whGA%2F The move signals an attempt by the new FDA regime, led by commish Margaret Hamburg, to reach out to friend and foe. In his role at Public Citizen, Lurie has repeatedly roughed up the agency, but Hamburg, as Forbes notes, would like the FDA to become more of an “arbiter” of public health. Lurie will be in the agency’s Office of Policy, where he will help develop strategies to facilitate medical product availability to meet critical public health needs, reporting to the Assistant Commissioner for Policy. The appointment was first reported by DrugWonks, which is run Peter Pitts, a former FDA official, a Porter Novelli pr exec and a co-founder of the Center for Medicine in the Public Interest Lurie’s appointment is one of a series of prominent additions to the FDA&#8217... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2905108 Mon, 19 Oct 2009 13:00:59 +0100 2905108 http://www.medworm.com/index.php?rid=2301661&cid=t_237269_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F03%2Ffda-lacks-credibility-says-judge-in.html BREAKING NEWS FROM "THE TAN SHEET"See also OverTheCounter Today Blog.A federal judge today ordered FDA to allow distribution of the Plan B emergency contraceptive without a prescription to 17-year-old women.Judge Edward R. Korman ordered the agency to rescind its restriction on nonprescription access to Plan B to women 18 years old and over because "no useful purpose would be served by continuing" to require that 17 year olds have prescriptions for the drug.FDA must comply with the order within 30 days. In the U.S. District Court for the Eastern District of New York, Korman also directed FDA to reconsider whether to make the drug available to women of all ages without a prescription.Korman said the requirement that the product be distributed only by pharmacists can continue.The judge ruled... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2301661 Mon, 23 Mar 2009 20:17:00 +0100 2301661 http://www.medworm.com/index.php?rid=2200623&cid=t_237269_131_f&fid=34989&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FGeneticsHealth%2F%7E3%2F3PfAqxjTbi8%2F The current Obama administration is putting plenty of attention on HEALTH, and I’m not talking about health care and insurance, although hopefully we’ll have good news on those fronts in the next four years. What I’m talking about are money and heads of offices – two factors that dictate how U.S. research in genetics and health will be conducted and approached in the next four years. This week, when President Obama signed the Economic Recovery Act, the NIH got $10 billion in funds for research, medical education and patient care. Another $19 billion went to a health information technology initiative for creating electronic medical records. In the political front, who is going to replace Daschle as candidate for the Health and Human Services Secretary? The Wall Street Journal writ... Genetics and Health blogs http://www.medworm.com/rss/comments.php?id=2200623 Fri, 20 Feb 2009 05:49:00 +0100 2200623