Ex-HHS Aide Says Overton Pressured Makary Over Vaccine Approval

Former senior HHS adviser Calley Means has accused FDA commissioner nominee Heidi Overton of pressuring former commissioner Marty Makary to approve Moderna's mRNA influenza vaccine despite his scientific objections, alleging that she conditioned assistance on other policy matters on his willingness to approve the product.

Means resigned 10/22, citing frustration with White House delays in implementing the Make America Healthy Again agenda and alleging that senior administration officials were allowing corporate interests to obstruct health policy reforms.

In an 11/8 CBS News Face the Nation interview, Means, the former top adviser to HHS secretary Robert F. Kennedy Jr., said he personally witnessed the vaccine-related exchange. Means alleged that Overton told him and Makary during a meeting that she could not help Makary unless he approved an mRNA influenza vaccine that he believed should not receive approval.

The vaccine, Moderna's mFLUSIVA, was approved in August for adults ages 50 and older, becoming the first mRNA influenza vaccine approved in the U.S. FDA had initially refused to consider Moderna's application earlier in the year before reversing course (see earlier story).

Means separately accused Overton of helping develop a more permissive FDA approach to flavored electronic cigarettes following Makary's resignation. He alleged that former White House chief of staff Susie Wiles and deputy chief of staff James Blair repeatedly pressured HHS and FDA to accommodate the vaping industry, despite objections from Makary.

Makary, in a statement to CBS, said tobacco industry representatives had used their administration connections to pressure him to approve fruit-flavored vaping products, but that he refused.

Blair disputed Means' allegations, saying his responsibility was to ensure FDA processed nicotine product applications according to statutory deadlines, not to advocate approval of particular products.

Means also alleged that lobbying interests influenced administration decisions involving kratom products and other health policies.

The accusations come as Overton is awaiting further Senate consideration of her nomination to lead FDA. The White House domestic policy adviser was nominated in August, appeared before the Senate Health, Education, Labor and Pensions Committee 9/24, but has not received a committee vote. Her nomination faced uncertainty even before the recent midterm elections, with several Republican senators expressing concerns about vaccine policy and access to the abortion drug mifepristone (see earlier story).

Means said Overton had been a major obstacle to the administration's Make America Healthy Again agenda and questioned her suitability to lead the agency.

A spokesman for Overton defended her qualifications, telling CBS that two former FDA commissioners disagreed with Means' assessment.

The interview raises questions about political involvement in FDA product reviews and regulatory decision-making, although CBS did not establish that improper pressure determined any agency approval decision.