Considerations for a New FDA Commissioner

February 26, 2016

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The Senate, in an 89-4 vote, confirmed Dr. Robert Califf as the new Commissioner for the Food and Drug Administration, which oversees the regulation of about one-fourth of the U.S. economy. With several “Holds” put on the nomination by more than a few members, including Senators Manchin, Markey, Murkowski and Sanders the question was whether or not he would be confirmed. Now the question is more like “what happens next?”

The FDA that Commissioner Califf arrives at is quite different from that of his predecessor Dr. Margaret Hamburg, who served as Commissioner from 2009-2015. Dr. Hamburg came onto the FDA scene after the agency had suffered a number of high profile setbacks – a perceived sluggishness in acting on the public health issues defined by the high profile withdrawals of drugs and questions of safety across many therapeutic categories. That span of time is perhaps best characterized by a survey from 2004 that showed that two-thirds of FDA scientists lacked confidence in FDA’s monitoring of prescription drug safety.

Taking over an agency that is dealing with these kinds of setbacks is certainly one kind of challenge. But assuming the helm of an agency that is doing well may be entirely another.

Today, the situation at the FDA is quite different than it was when Dr. Califf’s predecessor became Commissioner. While the years 2006-2009 saw an average of 22 new molecular entities (NMEs) approved each year, from 2009 -2015 the average number approved rose to 28, with the last two years seeing a significant increase in approvals to 41 and 45 respectively. While good news, that also is a challenge for a new commissioner – it is a track record that will have to be kept up. There will be a continued demand for FDA to approve pipelines not only at a good velocity, but with assurances that the products have been adequately assessed.

And it is not just the size of the pipeline, but what is in it. The approvals in the past year have seen sizeable increases in the number of drugs aimed at rare diseases and a large number are treating serious conditions such as cancer.

Beyond the target conditions, it is also the types of drugs that are now being considered. In recent years there are not only new biologics, but under Dr. Califf’s tenure, many stakeholders will be looking to the FDA to complete the regulatory issues associated with biosimilars to create greater clarity in the environment.

During the confirmation process, Dr. Califf saw many concerns expressed – from his associations with industry to the labeling of genetically modified foods. His challenge will not only be in addressing critics, but in maintaining the output of the agency while not taking the agency’s eye off the ball of safety – all during a time when treatments and the practice of medicine are becoming increasingly complex.