Congress to Scrutinize FDA Rules, Research Policies - FDA prepares for top-level changes while promoting transparency and product safety - BioPharm International


Congress to Scrutinize FDA Rules, Research Policies
FDA prepares for top-level changes while promoting transparency and product safety

BioPharm International
Volume 24, Issue 2, pp. 16-17


One of Sharfstein's last activities at FDA was to unveil the third phase of the agency's transparency initiative, which he headed as chair of the agency's Transparency Task Force. Launched in June 2009, the program has established an FDA Basics web page with broad information on agency operations and policies, plus an FDA-TRACK program that measures the performances and accomplishments of agency offices. This latest transparency segment aims to provide manufacturers with useful information on relevant agency policies and procedures. The FDA will post more information on key staffers and meeting presentations; will provide a system to answer sponsor questions quickly; and will clarify agency review processes and procedures for developing new guidances and regulations. The agency also seeks comments on a few more difficult draft proposals, such as whether to set specific timelines for guidance development and how to handle requests from manufacturers to appeal agency decisions.

Of particular interest are two industry proposals that the FDA is rejecting. There will be no binding advisory opinions in response to specific requests from sponsors for clearer decisions on proposed promotional and scientific exchange practices. The FDA says that it will continue to provide its view on whether promotional pieces for drugs and biologics meet regulatory standards before dissemination, but retains the right to change its opinion later on. The FDA also won't commit to notifying companies in advance of publicly disclosing information about the safety of a regulated product. The Center for Drug Evaluation and Research aims to notify sponsors at least 24 hours in advance of posting emerging drug safety information, but says it may not always be able to do so.

Sharfstein, moreover, is leaving the FDA without resolving the most contentious issues under review by the Transparency Task Force. A May (2010) report on phase two of the initiative sought comments on proposals to make public a broad range of confidential manufacturer information, such as when a company files an investigational application and whether that application is put on hold, withdrawn, or terminated (see BioPharm International, Regulatory Beat, July 2010). The FDA also is considering if it should disclose when a firm submits a market application for a new drug, biologic, generic drug, or medical device, and if such applications are withdrawn or abandoned. Most controversial is whether the FDA should make public refuse-to-file or complete response letters, and if the agency should disclose more information from adverse event reports, import evaluations, plant inspections, and product recalls.

Those issues raise "very interesting legal issues" and additional resource requirements, Sharfstein explained at his last FDA media briefing. Agency teams are assessing dozens of comments on these proposals, but resolution is not expected anytime soon.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,

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