Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Axios, in “How RFK Jr. Could Threaten Vaccine Markets,” by Caitlin Owens.
Following is an excerpt:
The not-so-slow drip of vaccine-unfriendly news coming from the Trump administration poses the longer-term question of just how much drugmakers would be willing to take before they decide the historically fragile market is too volatile to participate in.
Why it matters: The availability of vaccines in the U.S. isn't just dependent on whether the federal government has approved them; manufacturers have to be willing to continue making and selling them.
Actions taken by the Trump administration — including HHS Secretary Robert F. Kennedy Jr., a longtime vaccine critic — could ultimately convince drug companies that the market is too risky to enter or remain in, either because of depressed demand or an increased threat of litigation.
"It's a fragile market and it's not something we can take for granted, and it is a market we have seen drastically threatened before," said Richard Hughes, a professor of vaccine law at George Washington University and a partner at Epstein, Becker & Green. …
The big picture: The steady flow of vaccine news from HHS since Kennedy took office has been interpreted by many experts as an ominous sign of what's to come. But none of the major policy changes feared when Kennedy was first nominated have occurred — yet.
And some may never. Kennedy has explicitly vowed not to revoke the approval of the polio vaccine, for example (although he dodged saying the same about all vaccines).
But a government-endorsed study — no matter how poorly conducted — that concludes certain vaccines cause autism would mark a major escalation in terms of government actions with the potential to harm vaccine uptake.
Vaccine hesitancy itself can be bad for vaccine markets. Case in point: Moderna's struggle to succeed financially after the demand for COVID vaccines slumped post-pandemic.
"When uptake drops — which we want high uptake for herd immunity, public heath — but that has a revenue effect as well," Hughes said.
Another major policy grenade with potentially even more significance would be if Kennedy began to chip away at vaccine makers' federal liability protections, which have been fiercely criticized by Kennedy allies, including the anti-vaccine organization he founded.
Sources close to HHS expect the agency is interested in reforms to the federal Vaccine Injury Compensation Program (VICP), which was established under a law passed by Congress in 1986 in response to the threat of vaccine lawsuits leading to shortages.
The VICP is essentially an alternative legal system for resolving vaccine injury cases. Successful plaintiffs win money from the U.S. government, not vaccine manufacturers.
Weakening or removing liability protections for certain vaccines could be the thing that makes manufacturers contemplate leaving the market, experts say — or at least causes them to significantly raise prices. …
Of course, a big unknown is whether the White House would greenlight such a controversial move.
What they're saying: Kennedy was asked during the confirmation process what changes he's contemplating making to the VICP.
Kennedy allies in the past, as well as Kennedy himself, have argued the program takes away manufacturers' incentive to make vaccines safe.
In Kennedy's written response to senators during his confirmation process, he avoided answering the question.
"I will do nothing as HHS secretary that makes it difficult or discourages people from taking vaccines. As I testified to the Committee, I am not anti-vaccination. I support transparency and sound data for vaccines," he wrote.
Yes, but: A much more straightforward way to disrupt the vaccine market would be to simply cancel government contracts with manufacturers.
"That's probably one of the most directly impactful levers that he has," Hughes said.
"You take companies that have much smaller portfolios and a research and development pipeline ... these are companies that are very much put at risk when contracts get canceled" or the threat of liability increases, he added.
