More on Inspections
Transparency also is proposed on the compliance and safety front. The task force wants to indicate when FDA inspects a manufacturing
facility or clinical research site, along with whether a site visit uncovers violations or problems requiring corrective action,
or if the entity comes out clean. FDA currently makes public some inspection reports that raise important safety or regulatory
issues. Otherwise, interested parties have to request this information through the agency's freedom-of-information process,
which can take months, if not years. FDA believes that inspection results could help manufacturers achieve compliance, as
would posting untitled letters on the FDA Web site; FDA now lists more serious warning letters, and this would expand considerably
available information on company violations.
An important initiative would require regulated companies to inform FDA when they conduct a product recall. This would permit
the agency to advise the public on what is being taken off the market, the number of items involved, and cause of product
defect. The policy also would help FDA clarify which similar products are not being recalled, and when the recall is completed and terminated. Implementing this recall notice provision may require Congress
to give FDA mandatory recall authority, a change that could be accomplished by expanding proposed food safety legislation
awaiting action on Capitol Hill.
Another proposal would expand public access to adverse event reports through a more user-friendly information system. And
FDA looks to publish weekly listings of enforcement issues that are so important that the US Department of Justice is taking
the case to court.
An important consideration of the transparency initiative, said Sharfstein at a press briefing, is to obtain an "appropriate
balance" between expanded disclosure and ensuring confidentiality of trade secret information. The task force acknowledges
that protection of proprietary data is key to maintaining investment in biomedical R&D, and that a company's manufacturing
methods and product formulations are trade secrets that 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 in
withholding or releasing such information, as well as the often heavy cost of redacting trade secrets from to-be-disclosed
material. And while FDA is not proposing here to release raw data from clinical trials—as opposed to summary information—the
panel suggests that access to such information might uncover safety signals and help sponsors identify new product development
One factor guiding some FDA transparency proposals is the desire to harmonize US policies with those adopted by the European
Medicines Agency. EMA already discloses when a company files a marketing application or withdraws one, as well as the agency's
evaluation of the product. And the Europeans cite reasons for denying approval of a new product or additional indication,
similar to FDA's proposal for releasing CR letters.
Implementing many FDA transparency proposals will require legislative change. In unveiling this plan, Sharfstein explained
that the task force focused on what was the "right thing" to do, policy-wise, and not on the cost or feasibility of taking
such action. Now the panel 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 decisions on which proposals can be
adopted internally and where it makes sense to seek Congressional action.
Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at email@example.com