Opinion

The Upcoming Election and the FDA: The First 100 Days

The Food and Drug Administration regulates 20 cents out of every dollar spent by American consumers on products, though, despite their relevance to the economy and their impact on the health of every American, the FDA is generally not high on Washington’s political radar.

So when a new administration arrives on Jan. 20, 2017, the issues that the FDA deals with daily — new drug and device approvals, food safety, etc. — will not be at the top of their agenda. FDA employees will report to work on Jan. 21 and do their job.

This doesn’t mean there won’t be changes at the Agency — there will be regardless of who is elected. Therefore, what will those issues be in the first 100 days?

Commissioner:

It is conceivable, but not likely, that current Commissioner Robert Califf will be asked to stay on. His chances of sticking around are directly linked to the new Administration remaining Democratic, as Dr. Califf was appointed earlier this year. The likeliest scenarios, however, are that Dr. Califf will be asked like all political appointees to resign, so the new administration can appoint its own commissioner, or he will be asked to stay on for just a few months while a new commissioner is identified for appointment.

If asked, Dr. Califf has support to stay on in either a temporary or permanent capacity as he is perceived to be doing a good job in leading the agency and setting priorities.

Historically, it has taken several months to identify a new commissioner, and then a few more months to navigate the confirmation process. So a new commissioner is not likely to be in place before the end of spring, 2017, at the earliest.

If Dr. Califf leaves on Jan. 21, there will be need for an acting commissioner. The likeliest choice would be Stephen Ostroff who is currently deputy commissioner over the food program but served as acting commissioner before Dr. Califf was confirmed. He knows the job.

Who will be the next commissioner, if Dr. Califf is asked to move on? There is no way to predict this. The selection will be made either by the White House or by the new secretary of Health and Human Services and more likely through a consultation of the two. The Clinton team has numerous contacts within the academic and FDA worlds while the Trump team has fewer of such connections.

How important is the commissioner these days? The commissioner focuses on setting agency priorities, broad policies, budget matters, legislative initiatives, and similar matters. He or she has less direct involvement in product approvals, recalls, and other matters that affect the marketplace more directly.

Of course, the Commissioner is not the only political appointee at FDA. Some of the top staff also are likely to move on. But the vast majority of employees, and virtually all those involved in product decisions and direct public health issues, are not political and not expected to be affected by the election.

User fee legislation:

Every five years since 1992, there has been legislation to set user fees for product reviews and approvals. The legislation also establishes new priorities and new responsibilities for the agency.

The process is well under way for the 2017 version of the legislation. The FDA has met with affected industries, patients and other stakeholders. The FDA has issued a document with some of the commitments it wants to make — such as for greater involvement for patients in the medical product approval process.

The legislation must be enacted by Congress and signed by the new president by late spring or early summer for the FDA to continue to function without interruption. Under normal circumstances there’s no question that the legislation will be enacted in time. However, the past few years are anything but normal.

During the process of writing the legislation, stakeholders will seek to add their own provisions to the House and Senate bills. A top priority of the agency in the first 100 days of the new administration, and the new Congress, will be to navigate acceptable legislation through the process and emerge with a bill that addresses the major concerns of stakeholders.

There will be pushback from the FDA on one critical matter: adding new responsibilities to the FDA without adding commensurate money to carry them out. To do otherwise makes for a bad legislative outcome. While there is consensus on that point, for legislators the more common outcome has been to fail to adequately fund FDA, forcing the agency to prioritize public health responsibilities. The agency’s leadership will need to carry this message forward as the user fee legislation advances during the early months of the new administration.

Crisis management:

Everything the FDA does touches people — their health and safety — but sometimes there are failures; a contaminated food that harms many people; the withdrawal of a drug due to unexpected side effects. FDA is often judged by how successfully it handles crises, which in reality constitute a small percentage of its work, but which make the news.

What the FDA must do, in the waning days of the current Administration and in the first days of a new one, is to handle any crisis calmly, quickly, responsibly and transparently. During the final or opening days of an administration, how crises are handled tends to be scrutinized more than in other periods, and can be magnified.

In the first 100 days of the next administration this is what to watch for at the FDA — new leadership, new user fee legislation, and crisis management. Importantly, FDA is a stable, mature agency that reaches consensus decisions on critical matters of public health. So no matter who is in the White House, that legacy and sense of mission, responsibility and focus on the best interests of the consumer/patient will remain.

 

Wayne Pines is the president of health care for APCO Worldwide, and former associate commissioner of the U.S. Food and Drug Administration.

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