CDER Abandons “Drug Watch” Program To Communicate Safety In Favor Of Asterisk

FDA issues final guidance describing its approach to communicating drug safety information, including emerging information, to the public.

FDA will notify drug sponsors that emerging drug safety data will be posted on the Center for Drug Evaluation and Research Web site at least 24 hours before the information is communicated, the agency says in a final guidance issued March 2 outlining how FDA plans to communicate drug safety information to the public.

"Today's document captures the evolution of our thinking since the initial issuance of the draft guidance in May 2005," CDER's Associate Director for Safety Policy and Communication Paul Seligman stated during a same-day press briefing on the guidance.

"The feedback we have received to date from patients, providers, as well as from staff internally at CDER ... has been uniformly positive and in strong support of the need to get out emerging information in a timely, fair, balanced and impartial way," he said.

The final guidance, however, does diverge from the draft guidance in the way FDA plans to communicate this emerging information to the public. Instead of the previously proposed Drug Watch Web site, the agency has launched a Drug-Specific Information Web site under the CDER home page, which will contain information about drugs that are the subject of a public health advisory or an alert. Drugs that are the topic of an active FDA safety alert are identified with a red asterisk.

The agency's draft guidance included plans to develop a Drug Watch Web site to list drugs it considered as having significant emerging risks (¹ (Also see "FDA "Drug Watch" Website To Include Three Categories Of Safety Information" - Pink Sheet, 5 May, 2005.)). The concept had been criticized however, and more recently, its fate appeared to be in question (² (Also see "Drug Safety Concerns Could Affect Early Review Stages, FDA's Gottlieb Says" - Pink Sheet, 11 Sep, 2006.)).

"A concern expressed by some who commented on the May 2005 draft was the use of the proposed 'Drug Watch' name for this initiative, and the potential to confuse it with the long-standing MedWatch program," Seligman said.

As far as the decision to use a red asterisk to communicate safety information, the FDAer said, "I feel strongly that such an approach readily achieves our goal, alerting those who need to know that a drug has recent safety information that should be considered in making prescribing and use decisions."

The Index to Drug-Specific Information Web page will provide the most current safety information accessible to the public. FDA will update the information "on a periodic basis to reflect new information that becomes available," according to the guidance.

"We intend to update alerts on patient information sheets and health care professional sheets to describe new information relevant to the emerging drug safety issue, or remove alerts after the emerging safety issue is addressed," the document says.

Although the guidance explains the agency's intention to notify sponsors before such information is posted online, the document notes, "Our communication of emerging drug safety information is intended to represent FDA's independent analysis of emerging information and FDA's scientific judgment as to the appropriate communication of this emerging drug safety information to the public."

The final guidance further outlines the kinds of drug safety information the agency will communicate, how it evaluates drug safety information, and the different methods of communication it uses - from labeling to public health advisories.

The document is part of a broader drug safety program at FDA, which began in November 2004 following the withdrawal of Vioxx from the market. Since February 2005 CDER has issued 86 health care professional sheets, 79 patient information sheets and 54 public advisories, according to Seligman.

The initiative also included an independent study by the Institute of Medicine evaluating the drug safety system. That report was issued in September (³ (Also see "Sweeping Changes At CDER Recommended In IoM Drug Safety Report" - Pink Sheet, 22 Sep, 2006.)). In response to the report, FDA recently formed a new Advisory Committee on Risk Communication.

Seligman also said FDA plans to launch a drug safety bulletin to be distributed to the public this summer. The agency had already announced plans to create the safety bulletin as a regular means for communicating drug safety information (⁴ (Also see "Drug Safety Bulletin Being Considered By FDA" - Pink Sheet, 18 Apr, 2006.)).

- Jessica Merrill ([email protected])