FDA again faces search for leader

Drug Store News,  Oct 10, 2005  by Michael Johnsen

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WASHINGTON -- No matter which school of thought you ascribe to in explaining why Lester Crawford abruptly resigned as commissioner of the Food and Drug Administration after only two months--whether it be the rigors of the job, unrelenting criticism over the agency's handling of Plan B and Vioxx or possible heretofore undisclosed financial holdings that may represent a potential conflict of interests--at the end of the day, the FDA is once again without a leader.

And that's a problem for the pharmaceutical industry. The last time the FDA was without a leader for an extended period of time, the industry complained that drug development slowed and many new drug applications were rejected by an overly cautious agency--an agency that approached every decision with conservatism.

Of course, operating under the direction of an acting commissioner has more often represented the status quo than not under the Bush administration. The agency has had a full-time commissioner for only about 18 months out of the four and a half years that President George W. Bush has been in office.

But today, that lack of accountable leadership comes at a crucial time for the agency. The FDA has suffered significant blows to its credibility--first by way of the Vioxx debacle and the ensuing debate that called into question the long-term safety of everything from cox-2 inhibitors to both prescription-only and over-the-counter nonsteroidal anti-inflammatory drugs like Mobic or Aleve.

Many critics have questioned the agency's loyalty to the public versus a loyalty to the very pharmaceutical industry it's been charged to regulate--manufacturers pay prescription drug user fees in exchange for a more timely approval process.

"In recent years, the FDA has demonstrated a too-cozy relationship with the pharmaceutical industry and an attitude of shielding rather than disclosing information," noted frequent FDA critic Sen. Chuck Grassley, R-Iowa, in a statement issued the day of Crawford's resignation. "The opportunity to name a new commissioner is a chance to take the agency in a necessary new direction. Now is the time to reform the FDA's culture and reassert that the agency's top priority is what's good for John Q. Public when it comes to reviewing drugs in the marketplace and making new miracle medicines available. FDA scientists and employees are by and large hard-working and committed to fulfilling the agency's mission. They deserve a commissioner who will reinvigorate the agency."

There also is question of the agency's loyalty to the public versus the administration that nominates the agency's leadership. The Bush administration skews conservative, understandably, and is said to oppose OTC availability of the emergency contraceptive Plan B. It was the reluctance of the FDA to issue a final ruling on the Plan B switch application that held up, in part, Crawford's confirmation process in the first place. Thus far, the agency had bucked the recommendation of its advisory committees in declining OTC approval for Plan B last year and had broken a promise made by Health and Human Services Secretary Michael Leavitt that the issue would be settled by Sept. 1. "Under [Crawford's] watch, the agency faced scrutiny over its response to various crises: [including] the failure to adequately separate science from what can only be seen as ideology-driven decision making," stated Sen. Hillary Clinton, D-N.Y., a staunch Crawford opponent.

Direct-to-consumer advertising has similarly come under fire, with critics charging that DTC advertising of newly approved pharmaceuticals with no post-marketing track record held the potential to exasperate potential drug safety issues with a fast uptake in trial.

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