In 1,2 Punch, Deputy Director of FDA and Leading Advocate on FDA's Tobacco Products Scientific Advisory Panel Resign

Shortly before the New Year, Dr. Greg Connolly - a member of the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) - resigned from the panel. Yesterday, Dr. Joshua Sharfstein - the Deputy Commissioner of the FDA - resigned, according to an article in the Wall Street Journal.

It is unlikely that this sudden gap in the FDA will be filled by individuals who are stronger advocates for drug safety and for tobacco control than Drs. Connolly and Sharfstein. Both are strong public health advocates who fought tooth and nails against deceptive or fraudulent practices of the tobacco and pharmaceutical industries.

According to the article: "The Food and Drug Administration's No. 2 official is leaving the agency after a busy 21-month tenure that included clashes with drug and device makers over tougher regulation. Deputy Commissioner Joshua Sharfstein, 41 years old, is taking the top public-health job for the state of Maryland, a spokesman for Maryland's governor said, with an announcement scheduled for Wednesday. The FDA is losing a regulator who has pushed for a greater emphasis on drug safety. For example, he helped bring about an unusual review of the diabetes drug Avandia last year that resulted in much tighter curbs on its use. The departure could have an effect on the FDA's coming release of new guidelines on medical-device approvals. Any significant restrictions will likely cause a backlash in the device industry, which has allies among Republican House leaders." ...

"After arriving in late March 2009, when he briefly served as acting commissioner, Dr. Sharfstein took on the FDA's device division, where a device for knee surgery had been cleared in late 2008 over the repeated objections of a half-dozen FDA scientists and managers. His review, prompted by articles in The Wall Street Journal in 2009, led to the FDA's announcement that it planned to revoke the approval of the knee device. The FDA also said it would likely toughen guidelines for an abbreviated device-approval process that is popular with the industry."

"Under Dr. Hamburg and Dr. Sharfstein, the agency is issuing more warning letters over manufacturing and marketing violations, while largely stopping the practice of letting companies spend months negotiating the content of these letters, according to industry lobbyists in Washington. Another change that has alarmed the industry is the focus by the FDA on punishing individual executives and corporate lawyers, not just companies, over alleged wrongdoing. In November, a former lawyer for GlaxoSmithKline PLC was indicted in a Justice Department and FDA investigation into Glaxo marketing practices. The company has said it was cooperating with the government. The lawyer has pleaded not guilty."

"Dr. Sharfstein's review of Avandia, the troubled diabetes drug, opened a rift with the longtime head of the FDA's drug division, Janet Woodcock, who had defended the drug as a useful option for patients. The sides came to a truce in September, with restrictions that all but ended new prescriptions of the drug while allowing patients still on it to continue to use it."

The Rest of the Story

It is not clear why Dr. Connolly and Dr. Sharfstein have resigned from their respective positions, as neither has spoken publicly about the reasons for their resignations. However, for individuals who are as dedicated and principled as Dr. Connolly and Dr. Sharfstein, it is common for these types of resignations to occur as a result of frustration due to political interference with science-based decision-making.

The state of Maryland is lucky to have a state health commissioner with as much expertise, dedication, and character as Dr. Sharfstein. The FDA's loss will certainly be the state of Maryland's gain.

In the mean time, one must wonder what is going on at the Agency if it is unable to retain individuals of the kind of experience, expertise, and character as Drs. Connolly and Sharfstein. The FDA has already come under scrutiny because of the perception of widespread political interference in agency decision-making and because of failures in its ability to handle even its existing responsibilities. I can only imagine the circumstances that would have led to the departure of these two fine individuals.