An important consideration of the transparency initiative, said Sharfstein in a May 2010 press briefing, is to obtain an "appropriate
balance" between expanded disclosure and maintaining confidentiality of trade-secret information. The task force notes that
protecting proprietary information is key to maintaining investment in biomedical research and development, and that its deliberations
need to address what information should fall under the trade-secret umbrella and what should be available to the public.
In its report, the task force notes that a company's manufacturing methods and processes and precise 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. FDA now treats most of industry-submitted information as confidential, even
if it does not fall under the trade-secret definition. The task force thus seeks to consider the public benefit in withholding
or releasing such information, as well as the often heavy cost of redacting confidential information from material to be disclosed.
Although 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 certain situations. This data may help sponsors identify new opportunities
for developing products and alert health professionals to potential safety signals.
One factor guiding some FDA transparency proposals is the desire to harmonize US disclosure policies with those adopted by
the European Medicines Agency (EMA) and other regulatory authorities. In proposing to list NDAs and to post information on
an application's status, the task force noted that EMA already discloses when a company files or withdraws a marketing application,
as well as the agency's evaluation of the product. EMA also posts its reasons for denying approval of a new product or additional
indication, similar to FDA's proposal for releasing CR letters.
Interestingly enough, EMA recently was criticized for failing to fully explain certain licensing decisions and adverse events.
The European Ombudsman took the regulatory authority to task for refusing to provide public access to safety reports, and
an article in the May 21, 2010, Lancet further challenged EMA for not explaining an approval decision. A Lancet editorial cited FDA's transparency initiative and recommended that the two authorities coordinate in this area.
Implementing many of the FDA transparency proposals will require legislative change as well as new rulemaking. In unveiling
the agency's Phase 2 proposals, Sharfstein explained that the task force focused on the "right thing" to do, policywise, and
not on the cost or feasibility of taking such action. In the coming months, the task force will review public comments on
the proposals, which will be accepted through July 20, 2010, to evaluate where disclosure may accelerate product development
and promote public health. FDA also plans to conduct a legal and resource analysis for each proposal and use the results to
decide how to move forward. Commissioner Hamburg will make the final decision on which proposals to adopt internally and which
proposals require Congressional action to revise rules that limit public access to drug information.
Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, email@example.com