Califf's Plans May Be Tempered By Election

Wayne Pines is president of healthcare and regulatory ­services at APCO Worldwide.
Wayne Pines is president of healthcare and regulatory ­services at APCO Worldwide.

FDA Commissioner Robert has two plans for what he wants to achieve during his tenure. One is long-term. The other ends in early 2017.

Califf is a realist and acknowledges that he has a good chance of being replaced next year. Donald Trump certainly will clean house of Obama appointees. Hillary Clinton may keep some Obama appointees, but will be pressured to replace high profile appointees such as the FDA commissioner. She will make this change perhaps not immediately, but sometime in the spring.

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What can marketers expect from Califf's remaining time?

His first priority is to hire. It is well known that the FDA has hundreds of vacancies. Government personnel/salary/recruitment procedures make simple hiring a daunting task. His recent predecessors have been unable to accomplish this basic task.

Another priority is legislation establishing new user fees for medical products. That legislation needs to be passed by next summer. The easy part is deciding what the actual user fees will be. But other major legislative provisions will be added, and they always are hard fought.

The top policy issue for marketers is how the FDA regulates product communications. This is also on Califf's list, but further down.

See also: Speeding up FDA Approvals Calls for Pause

Recent legal decisions questioning the FDA's regulatory authority cry out for modernizing the FDA's policies. In particular, there is pressure from many sources for the FDA to define how companies can communicate economic and other information to payers, as well as information about new drugs. Tying companies' hands through a lack of explicit policy no longer is acceptable to any stakeholder.

Califf said privately that he wants to advance the “off-label” issue. Drug and device marketers desperately need guidance. For Califf, the question is: Is there time? Can he create a consensus at the end of an administration?

Unfortunately, the smart betting is that his tenure will end without resolution of this key issue. We'll need to wait for the new FDA team next year.

Wayne Pines is president of healthcare and regulatory ­services at APCO Worldwide. He also is a member of the board of directors for the Alliance for a Stronger FDA.