By an overwhelming 93-1 margin, the Senate today passed the Food and Drug Administration Revitalization Act, sponsored by Senate HELP Committee chair Edward Kennedy (D-MA) and HELP ranking member Michael Enzi (R-WY). In addition to authorizing substantial new resources for the FDA through user fees and appropriations, “the bill establishes a system of active surveillance for drugs already on the market, and explicitly gives the FDA new authority through Risk Evaluation and Mitigation Strategies (REMS) to respond quickly and appropriately when previously unknown risks arise,” Enzi said in a press release.

At a May 8 National Press Club briefing sponsored by Health Affairs, former FDA commissioner and CMS administrator Mark McClellan praised the bill, calling it “the biggest set of changes in post-market drug regulations since at least 1962.” McClellan said that the FDA would “be doing no less than entering a new era” when a version of the legislation eventually clears Congress and is signed by the president.

The briefing marked the release of Health Affairs’ May/June issue, a thematic volume on managing risks and benefits in health care titled “The Shifting Benefit-Risk Landscape” and supported by an unrestricted educational grant from Johnson and Johnson.

McClellan said that the tug-of-war between prescription drug safety and access concerns would go on even after Kennedy-Enzi becomes law. In fact, McClellan predicted “a new phase in the pendulum swing” back towards access concerns. The FDA “is constantly criticized from both sides,” he said, on the one hand for providing too many restrictions on access to new drugs, and on the other hand for not being aggressive enough in ensuring drug safety. The widely publicized problems with Vioxx and depression medications helped spark a surge in public and congressional concerns about safety. However, “I think you’re probably going to see after this more of that pendulum swing coming back” towards access worries, said McClellan.

McClellan also cited the evolution of Kennedy-Enzi’s language authorizing REMS as an example of the interplay between safety and access concerns. Under the initial legislative language, he said, REMS “might have used in a very broad set of circumstances,” including for drugs with no special safety problems where the REMS might have caused more problems than they solved. McClellan said that many observers raised concerns about this language, and he cited Scott Gottlieb’s article in the new Health Affairs issue as an example. (See also responses to Gottlieb’s article by Kennedy and Enzi and by David Meltzer of the University of Chicago, who has served on the Institute of Medicine drug safety committee.)

Now, however, said McClellan, Kennedy-Enzi’s REMS provisions have evolved to the point where REMS would be applied only in cases “where there is specific significant identifiable risk” and where the use of a REMS “would make it possible for the FDA to approve a drug” that “might not get to market otherwise.”

Tags: Pharma