One of Sharfstein's last activities at FDA was to unveil the third phase of the agency's transparency initiative, a program
he headed as chair of the agency's Transparency Task Force. Launched in June 2009, the initiative first created an FDA Basics
webpage that presents general information on agency operations and public health policies. Next came an FDA-TRACK program
to provide the public with measures of the performance and accomplishments of agency offices and regulatory activities.
This latest segment of the project aims to provide regulated companies with useful information on FDA policies and procedures.
Some of this will be on the agency's newly launched FDA Industy Basics webpage. In addition, FDA intends to post more information
on key staffers and meeting presentations, provide a system to answer industry questions quickly, and clarify agency review
processes as well as its system for developing new guidances and regulations. FDA also seeks comments on several draft proposals
that are more complex and difficult, such as whether to set specific timelines for guidance development and how to handle
sponsor requests to appeal agency decisions.
More significant for industry is FDA's rejection of two other transparency initiative proposals. The agency decided it will
not issue binding advisory opinions on the legality of certain marketing and information practices by companies, as sought
by industry, similar to practices of the HHS inspector general and the Federal Trade Commission. FDA says that, instead, it
will continue to provide advice on whether promotional pieces for drugs meet regulatory standards prior to dissemination,
but retain the right to change its opinion later on. Issuing binding advisory opinions "may place inappropriate restrictions
on FDA's ability to respond to emerging issues to best protect and promote the public health," the agency stated in its January
2011 report, "Improving Transparency to Regulated Industry."
FDA also will not commit to notifying companies before publicly disclosing information about the safety of a regulated product.
The agency will try to discuss emerging quality problems with the manufacturer, and the Center for Drug Evaluation and Research
(CDER) will aim to notify sponsors at least 24 hours in advance of plans to post drug-safety information. However, FDA may
post information about a safety issue before consulting with the manufacturer if it feels it is necessary to do so to protect
Sharfstein is leaving FDA without resolving the most contentious disclosure proposals issued in its phase-two transparency
report, which was issued in May 2010 (see Pharmaceutical Technology's July 2010 Washington Report column). Specifically, the transparency task force continues to evaluate dozens of comments on
whether FDA should make public a broad range of confidential regulatory information, such as when a manufacturer files an
investigational application and whether such an application is put on hold, withdrawn, or terminated. A key issue is whether
to disclose when a company submits a market application for a new drug, biologic, generic drug or medical device, or when
that application is withdrawn or abandoned by the sponsor at a later date. Also in question is whether the agency should make
public refuse-to-file or complete response letters. FDA is considering expanded disclosure of information from adverse-event
reports, evaluations of imports, plant inspection reports, and product recalls as well.
These issues raise "very interesting legal issues" as well as additional resource requirements, Sharfstein explained at his
last FDA media briefing. Agency teams are assessing multiple comments on these proposals, and the review is "on track," but
resolution is not expected anytime soon.