FDA Drug Safety Bulletin Being Considered To “Streamline” Communication

Implementation of an FDA standard drug safety bulletin will be one area of focus for the agency's new Associate Director for Safety Policy & Communication Paul Seligman.

The bulletin would be distributed to the public on a regular basis, Seligman said April 18 during a press conference at the agency's 2006 Science Forum.

FDA said in November that the goal of the new position is to bolster the public's perception of the agency (¹ 'The Tan Sheet' Nov. 7, 2005, In Brief).

Seligman previously was director of the Office of Pharmacoepidemiology & Statistical Science, which is being eliminated as part of a reorganization of the center's drug safety activities.

"One of the areas we've been working on now is creating...a safety bulletin or adverse event reporting system bulletin that's used as a regular means for communicating important safety information to practitioners as well as the general public," Seligman said.

"Many of the forms that we use, for example, are things that communicate labeling changes, like public health advisories...We're going to look very closely at all the various pieces that we have now and see whether there might be an opportunity for consolidation or streamlining" drug safety communications, he added.

FDA Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb said in December that the agency was considering a regular report similar to the Centers for Disease Control & Prevention's Morbidity & Mortality Weekly Report (² (Also see "“Drug Watch” Sent Back To The Drawing Board; FDA Turning To MedWatch?" - Pink Sheet, 19 Dec, 2005.), p. 7).

Another FDA proposal for communicating safety issues to the public, Drug Watch, has been widely criticized. The website, which would describe emerging safety concerns to the public about marketed drugs, has raised concerns among sponsors who feel unsubstantiated drug safety information should not be released before FDA has fully evaluated its significance.

The Consumer Healthcare Products Association noted in comments to the agency that the website would likely "confuse and alarm the public" since the information could be incomplete or inaccurate (³ (Also see "FDA Drug Watch System May "Confuse" Consumers In Proposed Form - CHPA" - Pink Sheet, 15 Aug, 2005.), p. 3).

According to CDER Director Steven Galson, Drug Watch "hasn't been scrapped. We've collected all the public comments and are working through the different options for it moving forward. We haven't made any final decisions."

Seligman's responsibilities will include oversight of the Drug Safety Oversight Board and the MedWatch program, as well as the development of CDER-wide drug safety policies, including drug safety communications.

He will also "play a significant role in implementing recommendations from external organizations, such as the Institute of Medicine and the Government Accountability Office," the agency said.

Seligman indicated that the agency was considering revising its policy regarding releasing information from Drug Safety Oversight Board meetings.

"I've heard loud and clear in a variety of forums, including our own Drug Safety & Risk Management Advisory Committee, a desire for greater transparency in some of the internal decisions that we engage in," he said.

We will look "carefully and closely" at how the DSOB can "improve the flow of information," he added.

FDA also is considering appointing a government ethicist to the DSOB, as suggested by the agency's Science Board Chairman Kenneth Shine on March 31, Seligman said.

Seligman also noted he would focus on implementing a tracking system for drug safety reviews to ensure that reports, submitted to the Office of New Drugs, are evaluated and acted upon.

Seligman's office will include a staff of approximately eight. He will report directly to Galson.

[Editor's note: This story was contributed by " ⁴ The Pink Sheet ," your source for prescription drug news. For more information call 1-800-332-2181.]