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 The Washington Post, in “Trump’s FDA Nominee Grilled on Vaccine Meeting, Agency Staffing,” by Rachel Roubein. (Read the full version - subscription required.)
Following is an excerpt:
President Donald Trump’s nominee to lead the Food and Drug Administration was grilled Thursday over whether he would reverse course on several actions the administration has taken in recent weeks that have alarmed Democrats and public health experts — and even garnered concern from some Republicans.
Marty Makary, a Johns Hopkins surgeon and former Fox News contributor, said during his confirmation hearing that he would perform his “own independent assessment” of personnel, after the Trump administration fired hundreds of the FDA’s probationary workers. Some who worked on core services, such as reviewing medical devices and food safety, were subsequently reinstated.
But Makary refused to pledge to reschedule a federal vaccine advisory committee meeting that was intended to help select the makeup of next winter’s influenza vaccine, saying he was not involved in the decision to cancel it and would “reevaluate” which topics necessitate convening the agency’s independent advisers. Makary was repeatedly pressed on the issue by Democrats and Sen. Bill Cassidy (R-Louisiana), the chair of the Senate health committee, who said the move seemed to go against Health and Human Services Secretary Robert F. Kennedy Jr.’s pledge for transparency into the scientific process.
Makary, who rose to prominence by criticizing the medical establishment, is likely to be confirmed to helm an arm of the Department of Health and Human Services charged with making decisions touching the lives of every American. The roughly $7 billion agency has a wide mandate, overseeing the safety of vaccines, infant formula, tobacco products and more. It regulates pharmaceuticals as well as the majority of the U.S. food supply, both of which involve industries that have come under frequent fire from Kennedy.
Among Trump’s nominees for key health posts, Makary is one of the few who patient advocacy groups and some health experts have said, sometimes privately, is a well-credentialed pick. Yet, many patient advocacy groups haven’t issued public support for him, and some public health experts have expressed uneasiness with public statements he made amid the coronavirus pandemic.
Makary’s confirmation hearing comes amid a tumultuous time. The FDA, like much of the rest of the federal government, is facing the prospect of further cuts — unnerving staff at an agency that has been a top target of Kennedy, who last fall told some FDA officials to “preserve your records” and “pack your bags.”
During the hearing, Makary repeatedly invoked Kennedy’s “Make America Healthy Again” agenda aimed at addressing chronic disease and childhood illness, echoing some of the rhetoric Kennedy used during his confirmation hearings to describe his goals as the leader of HHS.
“If confirmed, I hope to ensure the FDA holds to the gold standard of trust in science, transparency and common sense to rebuild public trust and make America healthy again,” Makary said.
If Makary is confirmed as FDA commissioner, his real test will come if he’s asked to implement some of Kennedy’s proposals that public health experts have raised alarm over, such as potentially putting childhood vaccines through additional study — a move that could undermine confidence in shots that have long been established as scientifically sound. Kennedy is the founder of a prominent anti-vaccine group, and medical experts have warned that Kennedy has repeatedly disparaged vaccines and falsely linked them to autism in recent years. …
In light of the growing measles outbreak in Texas, Sen. John Hickenlooper (D-Colorado) asked whether Makary would be a “more enthusiastic” supporter of vaccination, while also recognizing parents have the final say.
In a Fox News op-ed Sunday, Kennedy said vaccines protect children and contribute to broader immunity in the community, but he also said parents should consult with their physician. Some public health experts say he should have more explicitly recommended vaccination as the safest and most effective method of preventing measles. In a Fox News interview this week, he said that the federal government will do a better job of “quantifying the risks,” adding that “at this point, we are recommending that people in those communities get vaccines.”
Makary said: “Vaccines save lives, and I do believe that any child who dies of a vaccine-preventable illness is a tragedy in the modern era. The rare times in which a child dies of measles, it is often in a setting of a co-morbid condition or severe malnutrition.”
One school-age child in Texas has died, which is the first known U.S. measles fatality since 2015. The child was not vaccinated and had no underlying conditions, according to the state health department. An unvaccinated New Mexico adult who tested positive for measles has also died, state health officials said Thursday afternoon. The person did not seek medical care before their death, and the official cause of death is under investigation.
Makary was pressed several times about a panel of outside vaccine experts who advise the agency, including on the makeup of each year’s influenza vaccine. The nominee said he had “no preconceived plans” to rearrange the members of that committee. He pledged that the panel would hold meetings while he was commissioner, while also saying that the ethics policy of the panel “deserves a look.”
Senators on both sides of the aisle — and both sides of the abortion issue — quizzed Makary on mifepristone, a commonly used abortion pill. The agency under the Biden administration allowed patients to receive the medication through the mail.
Makary repeatedly said he’d review the data, also saying he had “no preconceived plans” to make changes to the mifepristone policy.
Sen. Maggie Hassan (D-New Hampshire) grilled him further, saying she hopes he would “not unilaterally overrule scientists.”
“Senator, if you look at my track record, I have never been afraid to speak my honest scientific opinion,” Makary replied.
Throughout his career, Makary has had a contrarian streak, challenging long-held assumptions and “groupthink,” according to interviews with those who know him and a review of his writings and television appearances. As a Hopkins faculty member, he helped design a “surgical checklist” aimed at minimizing errors in the operating room. His book “Unaccountable,” from 2012, castigated the nation’s health-care system and argued for more transparency.
In his most recent book, “Blind Spots,” he critiqued medical “dogma.” This included warnings years ago against some children consuming peanuts until age 3 that he said inadvertently sparked more peanut allergies. Pediatricians now recommend the early introduction of peanut protein to infants at increased risk of developing an allergy. …
But some worry about Makary’s penchant for making provocative statements.
“Will he continue to provoke? Does he genuinely want to have some of these conversations?” asked Richard Hughes IV, a former vice president of public policy at Moderna who teaches vaccine law at the George Washington University Law School.
