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"[P]eople acting in a group can accomplish things which no individual acting alone could even hope to bring about." - FDR
News & Analysis | REG•WATCH Blog | Press Room
Wednesday, February 20, 2008
The Food and Drug Administration is moving forward with a controversial new policy to allow pharmaceutical reps to market drugs for unapproved uses, despite objections from Congress and public health experts.
FDA doesn't just approve drugs, it approves drugs for specific uses. However, doctors can prescribe drugs for unapproved, or "off-label," uses.
Under a law that expired in 2006, pharmaceutical reps were legally able to distribute journal articles touting the benefits of off-label uses. But, according to the Associated Press, FDA maintained some regulatory oversight: "Under the expired law, companies had to submit reprints of articles to the FDA before sending them to doctors. That way, the articles' accuracy could be reviewed."
If FDA chooses to finalize this policy, which it published today as "proposed guidance," drug companies would be able to use journal articles to market off-label uses willy-nilly. The AP article continues, "Under the new proposal, drug companies don't have to submit articles."
Off-label use of drugs is big business. According to The Wall Street Journal, "[FDA] is stepping into a high-stakes business issue, because off-label uses of prescription drugs are a mainstay of the industry — an estimated 21% of drug use overall, according to a 2006 analysis published in the Archives of Internal Medicine."
According to Merrill Goozner at the GoozNews blog, the pharmaceutical lobby pushed for FDA to go forward with the policy which will be a boon for the industry:
So what was in today's proposed guidance? It pretty much gives industry everything it was looking for. It would allow drug salespersons to drop off article reprints as long as they came from a peer-reviewed journal that had a conflict-of-interest disclosure policy. Articles from industry-funded supplements would not be allowed… Note what isn't in the policy: It doesn't say that the studies of unapproved uses must be from randomized controlled clinical trials, which is the gold standard of medical research.
Rep. Henry Waxman (D-CA) caught wind of this policy last November and asked FDA to refrain from going forward. More on that here and here.
Monday, February 11, 2008
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Friday, February 08, 2008
Rep. John Dingell's Energy and Commerce Committee recently began an investigation into the use and safety of bisphenol-A, a chemical commonly found in a host of consumer products including plastic bottles. In a Feb. 6 article, ABC News reporter Justin Rood provides an update on exactly what the committee has been looking into.
According to the article, Dingell is particularly concerned with the work of scientific consultants. The article discusses one of those consultants, the Weinberg Group, which may be designing its scientific research in order to produce conclusions about bisphenol-A that downplay the negative effects of the chemical: "The Weinberg Group may play a role in arranging just the kinds of expert panels and scientific research the chemical industry points to in defense of its products, Dingell suggested."
The charges against the Weinberg Group are similar to those made against Sciences International, a contractor who the National Toxicology Program was paying to investigate the effects of bisphenol-A on reproductive health. (More on that here.) The Weinberg Group is not listed as a recipient of federal contracts or grants, according to FedSpending.org.
The scientific uncertainty surrounding bisphenol-A for years has prevented meaningful government intervention. Not only has use of the chemical gone unabated in consumer products, the public is in the dark as to which consumer products might contain bisphenol-A and what the ramifications might be.
At the very least, the public deserves to know the full set of facts about bisphenol-A and the companies who use it.
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