Jill Wechsler
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Transparency is the new mantra shaping biomedical research, production, regulation, and marketing. The US Food and Drug Administration
and the National Institutes of Health (NIH) are requiring more disclosure of financial relationships between the industry
and scientists and physicians. A new FDA-track program will issue regular reports on the work and performance of 100 agency
offices. Health reform legislation authorizes public access to more extensive information on health-related activities, including
formulary listings, out-of-pocket costs, and payments from pharmaceutical companies to health professionals. Some members
of Congress would like to go further and require public disclosure of prices charged for pharmaceuticals, as well as for hospital
care and doctor visits.
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.
