Healthy Skepticism Library item: 18480

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Taylor L
FDA 'must publish all safety, efficacy data from drug apps'
Pharma Times 2010 July 22
http://www.pharmatimes.com/WorldNews/article.aspx?id=18242

Full text:

The US Food and Drug Administration has been urged to make all summary safety and efficacy data from drug marketing and product applications routinely available to the public, and not just when it believes this would be in the interests of public health.

Routine release of all such data will enhance scientific innovation and discovery, according to advocacy organisation Public Citizen’s Health Research Group (HRG), responding this week to proposals by the FDA Transparency Task Force to amend agency policies on disclosure of information from product applications (which seek authorisation to conduct clinical trials on drugs or devices) and marketing applications.

To date, the agency has generally declined even to acknowledge that such applications have even been filed, much less divulge pre-approval safety or efficacy information, says the HRG. In the few cases where such disclosure has been required, actually doing so has been hampered by the combination of regulations – some requiring disclosure and others prohibiting it, it adds.

Releasing all safety and efficacy data will boost scientific innovation and discovery because scientists may be unaware that prior research has detected a lack of either safety or efficacy and may continue researching related products, “squandering time and money and going down roads already proved to be dead ends,” says the Group. Moreover, it points out that progress in science is based on the free publication of study results and on the public release of data, allowing scientists to build on the experience of others.

Implementing such a policy would not “competitively harm” manufacturers, it asserts; indeed, industry may “realise many benefits” from the release of information, including spurring new innovation and curbing duplicative efforts. The Group also points out that in its report, the Transparency Task Force had said the industry had not demonstrated that “blanket protection of aggregate information is warranted to maintain incentives for innovation.”

The FDA must also disclose raw data from clinical trials, the Group goes on. While the advent of clinicaltrials.gov, born out of the 2007 FDA Amendments Act, provides some basic information about clinical trials, companies currently only have the incentive to publish favourable trials, which can have misleading effects on researchers and the general public, it warns.

“The clinical data from one drug will rarely enable another firm to take any short-cuts or realize any savings on clinical trials of a different drug. Therefore, the release of clinical data will not cause the sponsor competitive harm,” it claims, adding that, in particular, safety data will rarely have any bearing on work on another drug, even if related, and that the courts have generally found that clinical data submitted to FDA is not confidential commercial information.

Summary safety and efficacy data for all abandoned, withdrawn or denied marketing applications should also be made available, not least because this is critical to doctors prescribing off-label uses of drugs, it adds, citing as an example the case of Pfizer’s anti-inflammatory Bextra (valdecoxib), which was withdrawn from the market in 2005. When the FDA released the medical officer’s review and other material after approving three of four uses in the New Drug Application (NDA) for Bextra, it redacted information discussing the fourth use (treatment of acute pain), the approval of which the agency had denied.

“After Bextra came on the market, it was touted in a journal article for this unapproved use, and many physicians prescribed it for that use. In response to a lawsuit filed by Public Citizen, the FDA released some of the information redacted from the medical officer’s review, which showed that the FDA had denied approval for use to treat acute pain because of safety concerns. Proactive release of the portions of the medical officer’s review addressing the unapproved use would have protected patients put at risk by this dangerous drug,” concludes the HRG.