The 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.
The release of 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 Group asserts that FDA must also disclose raw data from clinical trials. 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.
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. However, 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.