Biden Presidency Unlikely to Interfere in COVID Vaccine Approvals

The bitterly fought U.S. presidential battle may drag on for some time if the results are contested, but should Democrat Joe Biden emerge victorious, his administration is expected to take a more hands-off approach to the FDA on COVID-19 vaccines and therapeutics.

President Trump has challenged top health officials throughout the pandemic and sought to override the FDA on its guidance on Emergency Use Authorizations for vaccines, claiming that the agency delayed vaccine and therapeutic approvals for political reasons.

Most recently, the president hinted at a pre-election rally that he may fire Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases and a prominent leader in the U.S. coronavirus response, after the election.

Biden has claimed that he would handle the pandemic and the experts guiding the country through it differently than Trump has. He has pledged that he would not interfere with or question the work of the FDA and other public health officials.

On the issue of drug pricing, analysts Rick Weissenstein and Eric Assaraf of the New York-based financial services firm Cowen predict that a Trump re-election would likely consist of more executive orders and Medicare pilot programs for lowering drug prices.

The analysts say that the more aggressive drug-pricing approaches Biden has pushed, such as limiting the launch prices of new specialty drugs that don’t face competition, aren’t likely to come to fruition with a Republican-controlled Senate.

Biden has also said that he wants to allow drug imports, set limits for drug price increases based on inflation, allow Medicare to legally negotiate lower drug prices and kill the tax breaks pharma companies get for advertisement spending. He has also expressed interest in forming an independent drug price assessment group that would hammer out prices for new and existing drugs.

“Biden could provide an environment for incrementally more pricing pressure on drug companies if he is elected, but we don’t expect any major changes,” investment firm Morningstar said.

Trump said drug pricing was a key issue for his administration’s first term. Among the efforts he pushed were his “most favored nations” executive order that links Medicare Part B and D prices to lower prices in other countries; a drug importation executive order that some states hope to implement; reform via executive order for how discounts are negotiated by pharmacy benefit managers and sent on to Medicare beneficiaries; and a proposal that would force hospitals to give discounts on insulin and EpiPen.

Those proposals were criticized as having little potential for impact due to a lack of detail and the fact that many of them were in the form of executive orders rather than legislative initiatives.

“I think, in the drug area, you really can’t do a lot without legislation. Doing things through regulation, it’s really not clear whether you have the authority,” said Paul Ginsburg, director of the USC-Brookings Schaeffer Initiative for Health Policy. “In a sense, you’re likely to get sued by the manufacturers to block the approaches you want to put in, which means it could take years to get something launched, whereas with legislation, you’re establishing a clear statutory basis for doing things.”

Whoever prevails in the election, the COVID-19 pandemic will remain a strong focus for the foreseeable future, so it is uncertain how much attention drug pricing legislation will get in a divided Congress, experts say.

Walid Gellad, director of the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing, said: “There will be discussion about pricing in the context of COVID, but I don’t see a larger push given the election will be behind us,” he said. — James Miessler