Opening up enforcement
A more substantive and controversial Phase 2 initiative, which was published May 21, 2010, includes 21 proposals for disclosing
regulatory documents and actions (posted on
http://www.fda.gov/ under "transparency"). In the area of field inspections of manufacturing facilities and clinical research sites, FDA wants
to list when a company is inspected and whether that site visit uncovered violations or problems requiring corrective action,
or whether the entity passed inspection. FDA currently makes public only those inspection reports that raise important safety
or regulatory issues. Otherwise, interested parties have to request this information through the Freedom of Information program,
which can take months, if not years.
The task force received fairly broad support for regular posting of inspection reports, including from some companies that
feel the information can help industry understand FDA expectations and achieve compliance. The task force suggested that inspection
results may assist manufacturers and research sponsors in selecting distributors, contractors, and other business partners.
A related idea is for FDA to provide summary information about common violations to enhance public understanding of its inspection
Manufacturer compliance status also could be clarified by posting untitled letters on the FDA website, expanding what the
agency now does with Warning Letters and with untitled letters related to biologics and drug marketing. These listings would
include a company's response to the untitled letter, if the firm desires, along with the enforcement close-out notices that
FDA recently began to make public. Despite concerns that posting all untitled letters could lead to information overload and
the idea that untitled letters are not very useful, the task force decided that these documents can alert the public to violative
practices and encourage industry compliance.
Another important change proposed in the Phase 2 document would require manufacturers to inform FDA when they initiate a product
recall so that the agency can advise the public about defective, mislabeled, or potentially harmful foods or medical products.
Because the agency has limited authority to remove violative items from the market, most product recalls are voluntary; companies
usually inform the agency of their actions, but are not required to do so.
Providing information about a recalled product, the number of items involved, and the cause of the product defect is central
to protecting public health, the task force states. At the same time, FDA wants to be able to clarify which similar products
are not being recalled and when the recall (including the removal from market or destruction of affected products) has been completed,
thus eliminating the potential for danger.
Implementing this type of recall notice provision may require that Congress give FDA mandatory recall authority, as proposed
in food-safety legislation awaiting action on Capitol Hill. The recent massive recall of children's cold medicines by Johnson
& Johnson's (New Brunswick, NJ) McNeil subsidiary has bolstered support in Congress for granting FDA recall authority over
drugs and medical products, along with other enforcement powers.
Several additional transparency proposals could enhance public access to information about product safety and agency enforcement
priorities. One initiative would expand the availability of adverse event reports by establishing a user-friendly system that
makes it easy to search for safety reports on specific products. FDA also proposes in its Phase 2 document to publish weekly
listings of high-level enforcement issues (i.e., those events that require involvement of the US Department of Justice). Posting
agency work plans after five years is suggested as a way to convey FDA enforcement priorities without providing information
that can help noncompliant entities avoid detection.