Who Will Lead the FDA?

Moments after the president’s address to Congress concluded on Tuesday night, Vox ran the following headline: “The president is serious about dismantling the FDA to usher in more medical ‘miracles.’ That’s wrong.”

Unsurprisingly, Vox‘s conclusion is what’s wrong. But if the writer, Julia Belluz, is correct about Donald Trump’s intention to transform the FDA, it could indeed usher in a new era of extraordinary medical innovation, sharply reduced medical costs, and a greater quality of life.

Americans should embrace FDA reform—the agency simply does not operate well in an age of personalized, IPhone-like medical technology. While the FDA is often left out of discussions on health care costs, it is one of the leading drivers of high drug prices, and quite literally prevents patient access to important treatments by blocking drugs and medical devices from entering the market. It was heartening to see the president acknowledge the role that this frequently overlooked and sadly outdated agency plays in the health system.

But questions remain as to who will steer the FDA—and in which direction. Below is a list of possible candidates for FDA commissioner, and which reforms they might pursue:

Jim O’Neill: A Silicon Valley investor and associate of Peter Thiel, O’Neill may be the greatest “outsider” of all of Trump’s potential picks. O’Neill has also advocated for perhaps the greatest overhaul of the FDA by bringing it back to something resembling its earlier mission: Simply holding it accountable for drug safety, rather than demanding detailed, lengthy studies—often taking upwards of 12 years and costing billions of dollars—to prove the efficacy of drugs. This would no doubt be transformative, saving time and money and overhauling the medical marketplace as we know it today.

-Scott Gottlieb, MD: A former FDA deputy commissioner, Gottlieb has been writing about the FDA for years, and would bring a unique understanding of the FDA’s culture along with a slew of detailed proposals for reform. Gottlieb may not fit into the “outsider” mold of the Trump administration, but this could be an asset.

Gottlieb’s ideas include restructuring the agency so that employees who are responsible for reviewing drugs are separate from those responsible for approving or rejecting them. The reviewers would present their findings to another branch of the FDA, which would then make an up-or-down decision within a reasonable timeframe regarding the drugs or medical devices in question. Gottlieb believes this diffusion of responsibility would alleviate the pressure FDA reviewers feel to make the correct decision on whether medical products should be introduced to the market, which leads them to drag their feet and avoid the decision altogether.

Gottlieb’s proposal addresses one of the central criticisms of the FDA: It takes far too long, and costs far too much, to bring drugs to market. Gottlieb has also suggested removing the placebo requirement from drug trials for well-documented, serious illnesses—in other words, people who are ill should not be required to take “sugar pills” during trials for potentially lifesaving medicines. These and other suggestions could convert the FDA into a more efficient and humane agency.

-Joseph Gulfo, MD: Like Gottlieb, Gulfo is a medical doctor, an important qualification since physicians are frequently the target of restrictive FDA regulations. And like Gottlieb, Gulfo has written extensively in the Wall Street Journal and elsewhere about the FDA, though his prescriptions tend to be more dramatic.

For over a decade, the FDA has been attempting to prevent doctors and pharmaceutical companies from promoting “off-label” use of drugs—that is, recommending drugs for uses other than those which the FDA has approved. This has led to wasted time and legal resources and unnecessary heartache; doctors are accustomed to prescribing safe drugs for a variety of purposes, whether or not the FDA gives them its blessing. The FDA’s repeated attempts to place “gag rules” on doctors have been struck down by courts, but not without cost (see the tragic story of Dr. Peter Gleason, whose medical license was revoked after he promoted the safe, off-label use of a particular drug, and who committed suicide after being hounded by the FDA).

Gulfo is determined to battle this particular FDA practice: Writing in the Wall Street Journal in March 2016, he claimed that “[M]ore court cases undoubtedly will be coming if the FDA does not take the lead in ironing out a better policy about promoting off-label uses of approved drugs, consistent with the First Amendment. If it doesn’t, the courts will.”

Gulfo suggests that rather than continue to fight off-label use, the FDA should accept it as part of the process of expanding medical knowledge. If the FDA encouraged physicians to provide medicines that work for their patients, learned from those practices, and integrated them into their own medical databases, the relationship between the FDA, doctors, and pharmaceutical representatives could become far less hostile and more collegial. This might mean greater medical knowledge would be available to everyone, and better care would be available for patients as well.

-Sally Satel, MD: Satel, a psychiatrist and American Enterprise Institute scholar, has repeatedly criticized the FDA, particularly for its regulations on vaping products, which she claims struck “a dangerous blow to the health of about 37 million adult smokers.” She has long decried similar mandates, and her approach tends to be that of the careful reformer. For example, she encouraged the FDA to provide safety guidelines for e-cigarettes and other precautions even as she opposed their “[e]xpensive, time-consuming, and often vague” rules regarding vaping.

Each of these potential commissioners could revolutionize the way the FDA operates, and subsequently the U.S. healthcare system as a whole. Freeing the market to allow a greater variety of safe medicines and devices to reach patients could usher in, as the Vox writer wrote, medical miracles.

Devorah Goldman is an assistant editor at National Affairs.

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