Member Article

A change in administrations from Republican to Democratic usually ushers in increased enforcement, regulation and strategic initiatives. Most of the Trump regulations and initiatives will likely be scrapped where possible. They will be replaced by rules and guidance documents that have been held in abeyance during the previous administration, as well as numerous new initiatives. The following is a brief, top-line assessment of the changes we can expect over the next four years particularly in regard to enforcement activity, pandemic countermeasures, medical devices, pharmaceuticals and biologics, food and dietary supplements and cannabis.

Leadership

Biden’s first objective is the selection of a new commissioner. Dr. Janet Woodcock holds the position on an interim basis and is a candidate for the permanent appointment, along with former Deputy Commissioner Dr. Joshua Sharfstein. The choice is especially important given the desire to chart a new course for the agency. Biden and the new commissioner will want to fill a number of political positions, in order to put a stamp on the agency. There will be decisions to make on overall hiring, given the number of open positions around the agency. The new team will have a host of issues to address in all of the regulatory areas under the FDA’s umbrella.

Enforcement Activity

Warning letters in all areas were dramatically down over the past administration. That will likely change. District Offices are expected to regain the level of authority and responsibility characteristic of that during the Obama years. We expect more Warning Letters and inspections, and perhaps even more stringent activity, such as Consent Decrees and criminal enforcement in cases of egregious conduct. We also expect to see the release of additional Guidance Documents in a variety of areas.

Pandemic Countermeasures

Look for more Emergency Use Authorizations (EUAs) as well as more stringent regulatory scrutiny of existing and new COVID therapies. There is likely to be more collaboration between the FDA and other agencies as part of a government-wide effort to end the COVID-19 pandemic.

Medical Devices

One of the first priorities will be the negotiations between Congress and the White House regarding the Medical Products User Fees, which are already in progress. Enforcement is likely to increase from the lower levels during the Trump administration. Actions were down over the past several years. A number of actions initiated by the previous administration will be lifted, especially the regulatory reform mandate. There will be changes in personnel as Trump appointees are moved out of their positions. Digital health will also be on the front burner at CDRH.

It is expected that the FDA will regain some control over Lab Developed Tests (LDTs). HHS had, in the waning days of the Trump administration, asserted control over LDTs. That is likely to change under the new administration.

Pharmaceuticals and Biologics

Expect a push by the administration for more generic drug approvals. The same goes for biosimilars. In addition, Biden is likely to clear a path for importation of drugs from Canada.

Regenerative medicine is expected to be front and center, and the FDA is likely to move forward with increased regulation, as well as seek additional funding to support this initiative. We expect more efforts to address less common diseases. In addition, CDER will push more innovative approaches to clinical trials as well as other areas. Enforcement of GMPs will increase, as will be the case in all of the industries regulated by the agency.

Food and Dietary Supplements

There are several initiatives underway at the Center for Food Safety and Applied Nutrition. One project that will almost certainly remain in effect is the New Era of Smarter Food Safety initiative. A long-awaited decision on the definition of “healthy” may finally come to fruition. The absence of an FDA definition of healthy has complicated litigation around the country on these issues.

On the dietary supplement side, there may be a push from both the White House and Congress to revamp the Dietary Supplement Health Education Act (DSHEA) to give FDA more authority in regulating supplements.

Cannabis

The outlook for the legalization of marijuana has dimmed with opposition from a number of Republican senators. The FDA is likely to move ahead (slowly) on regulations for CBD. The FDA would probably prefer to resolve the issue of cannabis regulation through legislation.

Concluding Observations

The new FDA team will probably renew cooperation with non-governmental organizations (NGOs) and it is expected that Warning Letters and inspections will increase. The industry, in general, should expect the role of the FDA to be more aligned to the way it operated under the Obama and Clinton Administrations.

If you have any questions or would like additional information, please contact Mark Mansour ([email protected] or 202-906-8691) or your Dykema relationship attorney.

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