An important consideration of the transparency initiative, said Sharfstein in a press briefing, is to obtain an "appropriate
balance" between expanded disclosure and ensuring the confidentiality of trade secret information, which the task force acknowledges
is key to maintaining investment in biomedical R&D. The panel says that a company's manufacturing methods and processes and
its product formulations generally meet the trade secret definition and should remain private. But other data, such as clinical
trial results and adverse event reports, may be more appropriate for disclosure. The task force wants to consider the public
benefit withholding or releasing such information, as well as the often heavy cost of redacting trade secrets from to-be-disclosed
material. Although the FDA is not proposing to release raw data from clinical trials, as opposed to summary information, the
panel suggests that access to such information might be useful in some situations.
One factor guiding some FDA transparency proposals is the desire to harmonize US policies with those adopted by the European
Medicines Agency (EMA). The Europeans already disclose when a company files a marketing application or withdraws one, as well
as the agency's evaluation of the product. The EMA also posts its reasons for denying approval of a new product or additional
indication, similar to the FDA's proposal for releasing CR letters.
Implementing many of the FDA transparency proposals will require legislative action, as well as new rulemaking. In unveiling
these proposals, Sharfstein explained that the task force focused on what was the "right thing" to do, policy-wise, and did
not evaluate the cost or feasibility of taking such action. Now the task force will review public comments on these proposals,
which can be submitted through July 20, and conduct a legal and resource analysis for each item. Commissioner Hamburg will
make the final decision on which proposals can be adopted internally and where it makes sense to seek Congressional action
to permit more transparency in FDA decisions and documents.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, firstname.lastname@example.org