The more things change, the more things stay the same

The news that FDA Deputy Commissioner Joshua Sharfstein is resigning is yet another example, in our opinion, of how reforms to the food, drug, and dietary supplements in the country are insufferably impeded by lobbyists and special interest.

Mr. Sharfstein has been the most proactive of any FDA official in recent memory in protecting the consumer (which is his job by the way) instead of special interests. He will not likely share his reasoning for resigning for decades (like Dr. Michael Kessler did in his book) because he wants to make a living. One can postulate that the change in the political climate made Mr. Sharfstein a pariah and he did not want to spend the next two years fighting Congress.

In his short 21 month tenure, he took on the Big Pharma, the dietary supplement industry (to root out tainted supplement manufacturers), and Big Food, with safety of the consumer being the main goal. We have followed the FDA very closely since 1985 and have never seen such positive action as we did under Sharfsetin (and to a lesser degree FDA Commissioner Margaret Hamburg).

It is possible that with the passage of the Food Safety Modernization Act, Mr. Sharfstein felt that he accomplished his main goal. In our opinion, with new House reps already looking into why certain drugs were pulled off the market and why drug approvals are at their lowest levels in years, Sharfstein probably saw the writing on the wall.

It is our hope that Commissioner Hamburg will assure that the progress Mr. Sharfstein made was not made in vain and that his successor will be of a similar ilk. How confident are we that this will occur? If we take past history into account, not very.