November 30, 2016 at 5:00 am ET
The media are engaged in active speculation about how Donald Trump will govern. Having gone through many transitions, seeing this process both from inside the government and outside, I know that speculation in the weeks after the election has little to do with what actually happens once a new president and his team take over. In the case of the Food and Drug Administration, a tiny agency by federal measurements but one with vast responsibilities, speculation at this point has had little bearing on what the future holds in store.
When the Trump administration turns its attention to FDA – which likely will be after after the inauguration — there are six things that I hope are taken into account:
The basic mission of FDA is not political
FDA is a regulatory agency. Regulatory agencies are often viewed in negative terms, either for being too restrictive or too lenient. However, the FDA should be viewed differently. Its mission is universally viewed as valuable and necessary: to assure that our food and cosmetic supplies are safe, and that the drugs and medical devices are safe and work. Who would want anything less? There may be debate about some specific policies, and about how best to regulate, but there should be none about the need for and value of the FDA’s basic mission.
The FDA should not be viewed in a partisan political context, but rather as an agency whose basic mission is so fundamental to society that it should be protected from partisan politics. The current commissioner, Robert Califf, himself a political appointee, made that very point a few weeks ago when he explained why he deferred to a non-political staffer to decide whether to approve a new drug for Duchenne muscular dystrophy. Califf said scientific decisions such as drug approvals should not be made by political appointees but rather by a staff that must be nonpartisan and apolitical.
The drug approval process is working
Starting in 1993, when the FDA was initially authorized to charge drug companies for applications, there have been dozens of changes to the drug approval process (and almost as many to the device approval process, which also involves a fee for applications). Drug and device companies may sometimes complain about specific adverse decisions, but they are relatively few compared to the number of applications being processed. A breakthrough new drug or device can be approved in just a few months. The drug and device approval processes are now relatively transparent, consistent with the need to protect legitimate trade secrets. Legislation before Congress (the 21st Century Cures Act) would tweak the system still more.
The Trump “Contract with the American Voter” has one reference to the FDA: “Reforms will also include cutting the red tape at the FDA: there are over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.” The reference to 4,000 drugs is to generic drugs that have been backlogged at the FDA for years. There has been an effort to approve these drugs quickly; the barrier has not been intent or commitment, but rather an inability to hire enough people to review them.
Don’t involve the FDA in drug prices
The pharma-related issue that has been on the front pages, the price of drugs, is not an FDA issue. As the new administration seeks to replace the Affordable Care Act and save money on health care costs, it’s not a good idea to involve the FDA in drug pricing or other matters involving cost. That’s not FDA’s job and making it so could cause conflicts. The FDA should not be asked to consider the cost of a drug or device in deciding whether to approve it as safe and effective.
A hiring freeze would disproportionally affect the FDA
Hiring freezes are common during transitions. They are designed to send a signal to the public that the administration is serious about controlling federal spending. The FDA’s single most challenging problem has been an inability to hire. There are 700-plus vacancies in the Drug Center alone. The reasons include a slow hiring process, low salaries compared to what the private sector pays for similar talent, and the need for highly educated professionals. A new administration would only cause delays in product approvals and enforcement actions by placing a hiring freeze on the agency.
The FDA needs more money
The FDA has been notoriously underfunded for many years. There is consensus about this within all the stakeholder communities involved with FDA regulation – industry, consumer and patient groups, and professional societies. It seems as if each Congress passes new laws that the FDA is supposed to enforce but money is seldom if ever forthcoming. When the new administration considers its first budget, it should regard adequate funding of the FDA as a priority.
The FDA needs stable leadership
Over the years, the FDA has been without a permanent commissioner for months at a time. This lapse causes delays in making critical policy decisions. It denies the FDA a confident voice within the administration on budget negotiations and before Congress. A new commissioner usually is not named until months into a new administration, and the confirmation process causes further delays. The new administration should name someone quickly to head the agency that regulates products that account for 20 percent of consumer spending in the U.S. (The current presumption is that Califf, the current commissioner, will be replaced, but there would be support among many if not most stakeholders if he stayed on into the next administration.)
Wayne Pines is president of health care at APCO Worldwide and former associate commissioner of the FDA.
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