OPENING THE BLACK BOX
Most significant for pharmaceutical and biotech companies is the FDA initiative to provide the public with more information on field inspections, product recalls, and the status of drug development and market applications. The agency's Transparency Task Force suggests that broader disclosure about FDA activities will build public confidence in its decisions. In announcing the program in June 2009, Commissioner Margaret Hamburg emphasized the need to dispel the FDA's "black box" image by expanding its ability to explain agency rules and processes.Under the leadership of Principal Deputy Commissioner Joshua Sharfstein, the task force released Phase 1 of the initiative in January, which established an Internet-based "FDA basics" course to promote public understanding of FDA processes and policies. Phase 2 was unveiled May 21, 2010, offering 21 proposals for disclosing regulatory documents and actions. Some are quite far-reaching and will require Congressional action to implement. Phase 3, which should be released this summer, will propose ways for the FDA to improve communications with regulated companies, namely by streamlining guidance development and increasing meetings with sponsors.
To better explain its enforcement activities, the FDA proposes to make public when it inspects a manufacturing facility or clinical research site. The task force wants such listings to indicate whether a site visit uncovers violations or problems requiring corrective action, or if the entity comes out clean. Manufacturer compliance status also could be clarified by posting untitled letters on the FDA web site, expanding what the agency now does with warning letters and with untitled letters related to biologics and drug marketing.
An important initiative would require manufacturers to inform the FDA when they conduct a product recall so that the agency can advise the public on the number of items involved and the cause of the product defect. At the same time, the FDA wants to be able to clarify which similar products are not being recalled and when the recall is completed and terminated. Implementing this recall notice provision may require that Congress give the FDA mandatory recall authority, as proposed in food safety legislation awaiting action on Capitol.
Another proposal would expand public access to adverse event reports through more user-friendly information system. The FDA also seeks to publish weekly listings of enforcement issues that are so important that the US Department of Justice is taking the issue to court.