Life Science Compliance Update

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January 19, 2017

Interim FDA Commissioner Announced

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Dr. Robert Califf’s tenure as commissioner of the United States Food and Drug Administration (FDA) is slated to come to an end ahead of the January 20th inauguration of Donald Trump as president. Deputy commissioner Dr. Stephen Ostroff is expected to take over on an interim basis after the inauguration. Ostroff has previously been acting commissioner – from April 2015 to February 2016 he served as acting commissioner. Once Califf was sworn in, Ostroff became the FDA’s deputy commissioner for foods and veterinary medicine.

Califf Permanent Replacement

Scott Gottlieb

The leading candidate to replace Califf is said to be Dr. Scott Gottlieb, an Obamacare opponent who’s also a former deputy commissioner at the federal safety watchdog. Gottlieb, currently a fellow at the American Enterprise Institute, is also an assistant professor at the New York University School of Medicine and a former practicing physician and hospitalist.

While at the FDA, Gottlieb served as a senior advisor for medical technology, director of medical policy development and deputy commissioner for medical and scientific affairs. Before that, he was a senior policy advisor at the Centers for Medicare & Medicaid Services (CMS).

Jim O’Neill

Mr. Trump is also expected to be considering Jim O’Neill, a libertarian and Silicon Valley investor with no medical experience (a fact that has some healthcare experts concerned). O’Neill has also previously made controversial statements about the federal safety watchdog, including when he said the FDA should no longer evaluate whether medical devices or drugs are effective when considering them for approval. That 2014 statement was viewed harshly by experts, with some thinking that it demonstrates O’Neill’s lack of medical experience and the problems that come with that.

Peter Pitts, a former FDA associate commissioner under President George W. Bush, said it’s nearly impossible to separate safety and efficacy when considering pharmaceuticals. “People need to understand that safety doesn’t exist without the balance of risk,” Pitts noted while explaining “every drug has risks,” providing the example of side effects that might be acceptable for lung cancer drugs, but not aspirin.

Experts have also expressed shock and concern over O’Neill’s interest in anti-aging products, and his claim that immortality could be a possibility within the next forty years. O’Neill has said, “You can tell a lot about an era by listening to what people whine about. If we invest wisely in life extension technologies, in 40 years, we’ll all be able to annoy our friends with complaints like ‘immortality almost never works.’”

O’Neill has also made suggestions that donors should be permitted to be paid to donate their organs, a concept largely rejected by healthcare experts.

O’Neill also served as principal associate deputy secretary of the Health & Human Services Department under Bush 43. In that position, he was responsible for the FDA, the National Institutes of Health, the Agency for Healthcare Research and Quality, the Office of Public Health and Science, the Biomedical Advanced Research and Development Authority, and global health.

Such experience prompted Dr. Michael Carome, director of Public Citizen’s health research group, to say, “He is stunningly unqualified in terms of his understanding of medicine.” However, Carome also noted that he was “just stunned” when he heard Mr. Trump was considering O’Neill as FDA chief.

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