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- FDA Not to Restrict Pharma Makers From Promoting Unapproved Medicine Uses.
- IN A MAJOR VICTORY for drug companies, a federal judge has ruled that the government cannot restrict certain promotional activities by the pharmaceutical industry that encourage unapproved uses of their medicines. US District Judge Royce Lamb IN A...
- Research articles 1999-08-09
- FDA Seeks Advice From Blogger; Google Solves Pharma's Ad Problems
- The FDA sought the advice of John Mack, a blogger with 20,000 monthly readers who runs the Pharma Marketing Blog, on how drug companies should use the web to advertise their products. The agency usually likes to hear from lawyers, drug company executives and academics when it seeks regulatory advice....
- Blog posts 2009-11-12
- In Q2, Drug Companies Lobbied to Expand Many Government Healthcare Programs
- A look at what drug companies spent on lobbying in the second quarter of 2009 shows an interesting dichotomoy: It's a parade of selfishness that, if successful, may end up doing more to expand government-run healthcare in the U.S. than President Obama's reforms. by Jim Edwards
- Blog posts 2009-09-01
- GSK and Others See Massachusetts Showdown Over Drug-Marketing Reform
- There are two ideas floating in the world of politics to curb the way drug companies give doctors gifts and often biased information. One of them is a good idea, and one of them is a bad idea. Drug companies -- such as GlaxoSmithKline -- have chosen...
- Blog posts 2008-08-08
- Glaxo Gets an FDA Warning... With Teeth
- Well before Vytorin became a cause célèbre -- which is to say, about a year ago -- GlaxoSmithKline was the drugmaker getting slapped around by critics for downplaying or ignoring possible heart problems associated with its diabetes drug Avandia. That case, which led to new warnings on the drug's label...
- Blog posts 2008-04-12
- BNET Focus on Antidepressants: Part 2, Controversies
- While the antidepressant market is both robust and lucrative, as we saw in part 1 of this three-part series, it is also controversial. No drug category is so dogged by doubts and questions, and yet so widely prescribed, as antidepressants. The most recent major event in the...
- Blog posts 2008-10-01
- 14 Drug Companies Cited for Misleading Google Ads
- The FDA cited 14 drug companies for misleading advertising in sponsored ads among Google search results. Those cited: Biogen Idec, Sanofi Aventis, GlaxoSmithKline, Forest Laboratories, Cephalon, Bayer, Johnson & Johnson, Pfizer, Novartis , Genentech, Boehringer Ingelheim, Merck, Hoffman-LaRoche, and Eli Lilly. The citations, sent...
- Blog posts 2009-04-07
- NPR Producer: Goodwin Broke "Ironclad" Contract Over GSK Cash; Pitts Didn't Disclose Ties
- The producer of an NPR radio show has accused the show's host, Fred Goodwin, of breaking his contract by failing to disclose his ties to drug companies. The producer also denies that Peter Pitts, a former FDA official and an executive at Manning, Selvage & Lee, a...
- Blog posts 2009-03-09
- FDA to Allow "Off-Label" Unapproved Drug Promotion
- The FDA has "finalized" guidelines allowing drug companies to promote drugs for unapproved ("off-label") uses. The guidelines will allow companies to distribute peer-reviewed scientific literature discussing off-label uses. Drug companies and their right-wing stalking horse, the Washington Legal Foundation, have been pushing for this move for years....
- Blog posts 2009-01-13
- FDA Caves to Pfizer, Industry on Antibiotics Ruling
- The Food and Drug Administration has quietly withdrawn its order banning extralabel use of the antibiotic cephalosporin, so that it can "fully consider the comments" it has received on the issue. When the agency announced the order on July 3, drug companies and agriculture groups were outraged....
- Blog posts 2008-12-12
Additional Resources
- FDA Expands Use of Convera Search Technology for Drug Review and Approval Process
- VIENNA, Va. -- Convera (NASDAQ:CNVR), a leading provider of search and categorization software for enterprises and government agencies, today announced expanded use of the company's RetrievalWare search technology by approximately 2,500 scientific review staff within the Center for Drug Evaluation and Research CDER at the FDA. The FDA's CDER uses...
- Research articles 2004-06-22
- Drug Makers Gave Lobbyists an Xmas Gift -- Millions More to Lobby Obama Administration
- A New Year will bring a new president, a new FDA chief, many new drug regulations, and, possibly, health insurance reform. Mindful of the ton of major drug brands that will go off-patent in 2009, drug companies have not rested in their lobbying efforts over generics and patent issues. They...
- Blog posts 2008-12-31
- Dealing with Drug and Alcohol Abuse in the Workplace
- Drug and alcohol abuse is a serious workplace issue. Of the 16.7 million illicit drug users aged 18 or older, 12.4 million (74.3%) were employed either full or part time, according to the U.S. government. More than one in three (38%) workers between the ages of 18 and 25 are...
- Articles 2007-03-27
- Report: Company-funded studies of Pfizer epilepsy drug misleading | News from The Post-Standard -
- Report: Company-funded studies of Pfizer epilepsy drug misleading By The Associated Press November 11, 2009, 8:16PM Mark Lennihan / The Associated Press, 2009The Pfizer world headquarters in New York. Analysis of a dozen published studies testing possible new uses for a Pfizer Inc. epilepsy drug...
- News items 2009-11-11
- Man Bites Dog: Former Merck CEO Blasts High Drug Prices
- Most pharmaceutical companies insist that high drug prices are a natural consequence of the risky business of drug discovery, and that huge profits on marketed drugs are necessary to cover the costs of the 5,000 to 10,000 experimental drugs that fail for every one that succeeds. In fact, there are...
- Blog posts 2008-05-05
- FDA to Allow "Off-Label" Unapproved Drug Promotion
- The FDA has "finalized" guidelines allowing drug companies to promote drugs for unapproved ("off-label") uses. The guidelines will allow companies to distribute peer-reviewed scientific literature discussing off-label uses. Drug companies and their right-wing stalking horse, the Washington Legal Foundation, have been pushing for this move for years. They regard drug...
- News items 2009-08-07
- Pharmaceuticals: Next January, Medicare Part D will take effect, changing how the US government buys drugs and perhaps how drug companies develop them
- Pharmaceuticals: Next January, Medicare Part D will take effect, changing how the US government buys drugs and perhaps how drug companies develop them. Campbell Alliance Group estimates that the plan will make the government the purchaser of 40% of all drugs sold in the US. The plan will create even...
- Research articles 2005-10-31
- Behind Cephalon's Numbers: a Big Cancer Bet and Signs of Skepticism
- The FDA delivered to Cephalon a letter yesterday saying it would not approve expanded indications for its pain drug Fentora until the company gave it more information on how it would prevent the drug from being abused. Even though the Fentora situation is fixable, it's just the sort of headache...
- Blog posts 2008-09-16
- Some more on Tamiflu, influenza policy and drug regulation
- The BMJ has just published a cracking series of articles online, including a revised Cochrane Collaboration review, that throw out some hefty challenges to influenza policy makers, pharmaceutical companies, researchers, governments and drug regulators. The articles raise many questions about the evidence base that has been used to guide influenza...
- News items 2009-12-08
- FDA Loosens Rules for Overseas Drug Trials
- Merrill Goozner, a former Chicago Tribune reporter turned public-health advocate he heads up the Integrity in Science Project at the Center for Science in the Public Interest, notes an interesting and almost wholly overlooked Food and Drug Administration decision that may have the effect of subjecting clinical-trial volunteers in poor...
- Blog posts 2008-05-08
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