FDA's quarterly report that lists potential signals of serious risks for drugs is similar in design to a program that the agency proposed and then withdrew following industry criticism.

The new ¹ quarterly report, announced and posted on FDA's Web site Sept. 5, is in direct response to a provision (§ 921) in the FDA Amendments Act of 2007.

"There may be events on this list that you haven't heard about ... because we're putting these out even earlier than some of our other early communications," Office of Surveillance and Epidemiology Director Gerald Dal Pan said during a Sept. 5 briefing in Washington, D.C. describing the new site.

Among the potential drug safety issues that appear to have been disclosed for the first time is Purple Glove syndrome associated with Pfizer's anti-epileptic Dilantin (phenytoin injection). The initial posting covers the first quarter of the year and includes 20 drugs (see chart: " ² Autumn Harvest Of Winter AERS: FDA Investigates 20 Potential Risks ").

Some of the adverse event issues have already been made public such as possible association of fungal infection with tumor necrosis factor blockers.

The thrust behind the Web site, Dal Pan said, "is we're telling the public really at the earliest stage what it is we're working on."

"The public has told us over the last few years we want to know what's going on, we want to know what you're working on, and this is in response to that," Dal Pan said.

FDA explained that "for a drug to appear on this report, an FDA reviewer will have determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug."

The Ghost of Drug Watch Past

The report is highly analogous to the Drug Watch project FDA abandoned in the face of industry criticism.

As in the proposed Drug Watch site, the drugs listed are identified during each quarter by FDA staff as warranting further review.

Industry originally slammed the Drug Watch site, which would have provided FDA with a means to communicate information to the public before the agency reached any conclusions (³ Also see "Drug Safety Concerns Could Affect Early Review Stages, FDA's Gottlieb Says" - Pink Sheet, 11 September, 2006.).

At the time, Pharmaceutical Research and Manufacturers of America Chief Medical Officer Paul Antony said the information would be difficult to retract, and the public was unlikely to absorb updates or corrections (⁴ Also see "FDA “Drug Watch” Early Warnings Will Have Lasting Negative Effect, PhRMA Says" - Pink Sheet, 7 June, 2005.).

Drug Watch also had sparked concerns in industry that FDA was trading the issuance of reliable data for transparency (⁵ Also see "FDA To Continue Providing Emerging Safety Info, But Not Through Drug Watch" - Pink Sheet, 2 April, 2007., p. 25).

PhRMA said its key concern with the current report is "to make sure that patients do not inappropriately discontinue therapy without discussing the benefits and risks with their physician."

"What's more, the FDA needs to strive for communications that include the full context of the medication's benefits and risks in order for health care providers to have a thorough understanding of the new information," PhRMA said.

Paul Seligman, associate director of Safety Policy and Communication for CDER, acknowledged during the briefing that "this is the first time we're posting this. I will be the first to admit that there's some work and refinements that need to be done on this table."

However, Seligman noted that the agency does not expect the site to include the number of adverse events reported, anything about the seriousness or the nature of the safety signal, or links to previous safety announcements.

Even as FDA looks to develop a Sentinel system that would mine medical claims databases (see ⁶ [A#00700360002]), AERS is a growing resource for the agency. Consumer reporting has skyrocketed, driving a steady growth in AERS database submissions (⁷ Also see "Adverse Event Reporting Soars As Consumer Submissions Pass Physicians" - Pink Sheet, 23 June, 2008., p. 17). Seligman said he hopes the report will stimulate health care providers and consumers to provide additional AERs.

The agency hopes to post the second quarter report in the comings weeks, Seligman said.

- Becky Jungbauer (r.jungbauer@elsevier.com)

FDA List Of Potential Safety Signals Has 3 Pfizer Drugs, Echoes Drug Watch Site

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