Measure for Measure

  • by: |
  • 06/19/2006

Here’s an interesting and provocative story. Please note that one point I made to this reporter (not entirely represented in the final piece) was that RMPs play a very important role — but that they must be joined by other more innovative and inclusive programs.

Gottlieb Speech Signals a Sea Change in FDA Drug Safety Strategy, Advocate Says

Stephen Langel
Drug Industry Daily, June 19, 2006

A senior FDA official’s speech urging the agency to pull back from requiring risk management plans as a part of the drug approval process signals a major change in the FDA’s thinking on drug safety, an industry observer says.

Scott Gottlieb, the agency’s deputy commissioner for medical and scientific affairs, announced in a June 12 speech before the American Medical Association that risk management plans (RMPs), while important in some instances, may be too prevalent. As the requirement for RMPs becomes more pervasive, the burdens could become too much for physicians and their patients, he added. “I worry about the future,” Gottlieb said.

Instead, the agency should look to a more collaborative approach, placing more responsibility on the medical community’s shoulders to ensure that medicines are used correctly, Gottlieb said.

“I believe some of the same safety goals embodied in the RMPs could be achieved if we had more ability to collaborate more closely and effectively with physician organizations,” he added.

This announcement shows that the agency has realized that there is a better way to enhance drug safety than requiring RMPs, Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, told DID. This speech is a “very clear signal to people within the agency” that a change is necessary, he added. Drug safety “cannot be viewed as a punitive measure.”

Up to now the agency has used RMPs to show that they are doing something about drug safety, but these plans are an empty measure of success, he said. Gottlieb’s speech shows the agency is ready to stop “hiding behind” RMPs and take a better approach, Pitts added. Because doctors have the final say over their patients’ use of drugs, they must be more involved in the drug safety process. It is “crucial” for the collaboration that Gottlieb spoke about to take place, he said.

This speech may have been timed to coincide with ongoing Prescription Drug User Fee Act (PDUFA) negotiations and a growing call in Congress for a new FDA office to handle drug safety, Pitts said.

PDUFA is a vehicle for the agency to receive much of its funding, but that funding is tied to the FDA meeting specific performance goals. The speech may be a signal to Congress that the amount of RMPs the agency requires should not be used as a performance measure, Pitts said.

RMP meetings between the FDA and industry are considered part of the current PDUFA process. Congress must reauthorize PDUFA by Oct. 1, 2007.

The agency may also be using this concern about RMPs to head off lawmakers’ efforts to establish a new FDA drug safety office, by arguing that more collaboration, rather than further prescriptive approaches, is the right way
to go to increase safety, Pitts added.

But another industry source does not believe Gottlieb’s comments necessarily represent a new agency position. Gottlieb discussed many topics during the speech, including a balanced view about the importance and drawbacks of RMPs, Sara Radcliffe, the Biotechnology Industry Organization’s managing director of science and regulatory affairs said. Arguing that the portion of Gottlieb’s speech where he states his concerns with RMPs represents a change in the FDA’s view may be “reading too much into it,” she added.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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