Jill Wechsler
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Transparency is the new mantra shaping drug research, regulation, and marketing. Healthcare reform legislation provides more
public information on a host of health-related activities, including formulary listings, out-of-pocket costs, and comparative
assessments. The new law, as well as FDA and the National Institutes of Health (NIH), seek to shed more "sunshine" on the
financial relationships between industry, and scientists and physicians. Some members of Congress would like to go further
and mandate broader disclosure of drug prices, as well as hospital and doctor rates, (See "Price Transparency".)
Opening the Black Box
New Push to Showcase Price Data
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FDA also has launched a comprehensive Transparency Initiative to build public confidence in agency decisions by revealing
more about its policies and practices. Internally, an FDA-Track program will report regularly on the performance of 100 agency
offices to improve management, while also emphasizing the breadth of the agency's responsibilities and accomplishments.
More significant for industry, FDA's Transparency Task Force proposes extensive disclosure of information on field inspections,
product recalls, and the status of drug development and market applications. In announcing the program in June 2009, FDA Commissioner
Margaret Hamburg stressed the need to dispel the agency's " black box" image by expanding its ability to explain its rules
and processes. Under the leadership of principal deputy commissioner Joshua Sharfstein, the task force unveiled phase one
of the initiative in January, which established a Web-based "FDA Basics" course on agency activities. Phase three, due this
summer, will propose ways to improve how FDA communicates with regulated companies, primarily by streamlining guidance development
and increasing meetings with sponsors.
Much more substantive is phase two, which was published May 21, 2010, and offers 21 proposals for disclosing regulatory documents
and actions. Some are quite far-reaching and will require Congressional action to implement.
Most controversial is whether FDA should drop its long-held policy against releasing information on the status and substance
of investigational products. The task force proposes that FDA disclose when a company seeks permission to launch clinical
trials or to bring to market a new drug, biologic, animal drug, or medical device. FDA also wants to announce when such applications
are withdrawn, rejected, or delayed. The agency also wants to release Complete Response (CR) letters explaining why it is
not approving a product, as well as what the sponsor needs to do to get to market.
Pharma companies often elect to announce when they file an IND (investigational new drug application) or a license application
to demonstrate that a development project is moving forward or to comply with financial reporting rules. The FDA Amendments
Act, moreover, requires manufacturers to post information about ongoing clinical trials and their results on ClinicalTrials.gov/, and dossiers on some products are posted as part of FDA advisory committee deliberations. But FDA itself only announces
when it approves a new product.
That would change considerably under the task force proposal for FDA to disclose IND filings, including name of sponsor, date
of application and anticipated indication and trade name. The agency also would indicate when an IND is placed on clinical
hold or is terminated or withdrawn. Similarly, FDA would indicate when a company files a market application or efficacy supplement,
as well as when such applications are withdrawn or abandoned. Related to this, the task force wants FDA to be able to explain
that when a sponsor abandons or withdraws an application for an orphan drug due to internal business reasons, safety concerns,
or regulatory issues should not deter another party from developing that needed therapy.
A significant, and controversial, proposal is for FDA to release refuse-to-file notices and CR or not-approvable letters.
Sponsors often will issue a summary of a CR letter and a scenario for reaching the market in the future. But FDA wants to
provide full explanations of its delay decisions, and investors and consumers want to see those statements.
However, the transparency panel decided not to seek disclosure of refusal or CR letters to generics drug manufacturers, or
for manufacturing and labeling supplements; these contain considerable trade secret information that is considered less crucial
to drug development.
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