FDA's Approvable Problem - Pharmaceutical Executive


FDA's Approvable Problem

Pharmaceutical Executive

Fortunately, there's cause for optimism. "FDA is reaching out to pharma on a regular basis, asking for more open interactions," Russ Somma said. "And a number of companies have gotten together to work with the agency on different issues," such as the consortia for biomarker R&D in cancer, cardiovascular disease.

Unrealistic Hopes, Unintended Consequences

Yet whether the new safety regime will—or even can—produce safer drugs remains to be seen. Many people inside pharma, including scientists, argue that the status quo doesn't need fixing. "In the vast majority of cases, when we find adverse events after approval, the benefit/risk ratio of the drug doesn't change. That means the system is working," Pfizer's Gretchen Dieck said. "In a very few cases, like Vioxx, it does change—but then everyone throws up their hands and says, FDA is broken!"

Tuft's Chris Milne marshals statistics to back Dieck up. "Withdrawals of drugs happen in a cluster—every three to five years," he said. "But the actual rate of withdrawals is consistent over time at 3 percent." In other words, faster drug approvals seem not to result in riskier drugs.

Likewise, there's considerable skepticism over whether the safety profile of drugs can be significantly improved—pending the advent of disease markers and personalized medicine. What needs fixing, from this point of view, is the uninformed—and, therefore, unrealistic—expectations of us consumers, not to mention our politicians.

"We need to do a better job as a society in communicating that just because a drug is FDA approved doesn't mean it is totally safe," said FDA's Jenkins. "What people really have to be thinking about is, What is an acceptable risk for the real benefits?" In that light, it's ironic that the prolonged post-Vioxx public drubbing of pharma and FDA may have only further raised false hopes about drug safety.

"You had congressmen who know little about safety or the drug approval process second-guessing FDA and proposing legislation for FDA," Dieck said.

The main thrust of PDUFA IV, of course, is to beef up safety monitoring without slowing down approvals. The legislation gives FDA more muscle to hold drugmakers accountable for better—or, at least, more extensive—data collection and reporting before and after approval. To the extent that it formalizes the demands for increased detection of safety signals that are currently resulting in approvable letters, PDUFA will, at the very least, likely remove the element of surprise from the process, limiting the disruption of launches, and, projections.

It may be too much to hope for that the PDUFA safety reforms will serve to restore public trust in FDA—and, by extension, Big Pharma, which strongly and visibly supported the legislation. Recent polls suggest that the tide has turned and public opinion is growing more favorable. But many people interviewed for this article voiced fears about how the agency will fare when—not if—the next Vioxx happens.

"The increased burdens on FDA require much greater resources to implement properly," said APCO Worldwide's Wayne Pines. "Congress holds the agency responsible, and if it doesn't get more money, it may not be able to meet expectations—and that could have very troubling consequences." Pines is president of the new nonprofit FDA Alliance, which is lobbying Congress to adequately fund the agency to the tune of $2 billion. (For more information, see http:// http://www.strengthenfda.org/.)

Given that several influential congressmen are advocating something very much like tearing FDA down and starting over, the troubling consequences aren't hard to imagine. But even without another Vioxx, politics will always intrude. Next year's presidential election escalates the sense of uncertainty about the agency's agenda—and whether the pendulum will keep moving toward drug safety or begin tacking in the direction of speedier approvals.


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