ICYMI: In Letter to Makary, Sens. Murray, Baldwin, Alsobrooks Raise Alarm over Decision to Cancel Critical FDA Flu Shot Meeting Amid Worst Flu Season in 15 Years
*** VIDEO of Senator Murray’s FULL questioning AQUÍ***
Washington DC - Today, U.S. Senator Patty Murray (D-WA), a senior member and former Chairof the Senate Health, Education, Labor and Pensions (HELP) Committee, questioned Dr. Martin “Marty” Makary, President Donald Trump’s nominee to serve as Commissioner of the Food and Drug Administration (FDA) at a HELP committee audiencia on his nomination. Murray pressed Dr. Makary on the FDA’s abrupt cancellation—in the middle of the worst flu season in 15 years—of its annual advisory committee meeting to make recommendations for the flu vaccines for the upcoming flu season, which she llevó una carta pressing for answers about last week, and about whether he would uphold the science and evidence-based approvals for contraception and medication abortion such as mifepristone, which has been proven safe and effective for decades but is now under attack by anti-abortion extremists peddling cherry-picked junk science.
Murray began by pressing Dr. Makary on the sudden cancellation last week of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting: “Last week I sent you a letter, along with some of my colleagues, asking you about the FDA’s cancellation of that vaccine advisory committee meeting,” Murray said. “This is a meeting that takes place annually, for at least 30 years, to make recommendations for which influenza strains should be included in the flu vaccines for the upcoming flu season. And for the first time in decades, FDA cancelled that meeting—with no explanation given, no new date chosen. That is, I believe, unprecedented and dangerous.”
“In 2022, you raised concerns when the FDA was considering not holding a vaccine committee meeting to authorize COVID-19 boosters for kids 12 to 15, and at the time you said it was ‘unconscionable’ and ‘undermined the integrity of the FDA’s standard process’ to not hold that committee meeting,” Murray continued her line of questioning.
“So if you are confirmed, will you commit to immediately reschedule that FDA vaccine advisory committee meeting?”
Dr. Makary dodged the question, saying he was not involved in that decision and that he would “immediately reevaluate which sessions the leadership of that center, which decisions, which topics could benefit from…”
“So what goes into a reevaluation? This is done every year so we know what flu vaccine to have. What are you reevaluating?” Murray interrupted.
Makary again denied having any awareness or involvement in the decision, and said it was something he would “look at” if confirmed. “Okay, I am very unclear because the FDA is the gold standard for all of us,” Murray replied. “And this committee hearing is what has always been what we look to, the FDA look to, the American people look to, to determine what the flu vaccine is. What are you going to look at to make a determination and figure something else out now, decades into this? What are you re-looking at?”
When Makary dodged again, saying he was not involved in the decision to cancel the meeting, Murray interrupted: “I understand that, but I assume you would say ‘yes, I will reconfirm it immediately so we can let our public health experts and doctors know what flu [vaccine] to have next fall.’”
“As I understand it, the committee members and the scientists at the FDA, the career professional scientists at the FDA, look at the recommendations of the international GIP group…”
“I’m just asking, you just told me that you are going to ‘reevaluate’ it, and I want to know, what you are reevaluating it on,” Murray interrupted. “What are you looking at to make a decision whether to reconvene it?”
“In conjunction with the center director of the Biologics Center, I would reevaluate which topics deserve a convening of the advisory committee members on VRBPAC and which may not require a convening,” Makary said.
“So what would we base our decision on?… How will we know what flu to take next year—vaccine—if this committee doesn’t reconvene and make their recommendation?,” Murray pressed.
Makary again dodged the question and said again that he wasn’t involved in the decision. “I just thought you would say ‘yes we’re, going to reconvene’ because who knows what’s coming,’” Murray replied.
Murray continued her questioning by asking about FDA’s role in upholding the science on mifepristone, a critical medication millones of women rely on for reproductive health care including for abortion care y miscarriage cuidado. “On mifepristone, because FDA does play a really critical role in making sure we have safe and effective medications. Contraception and medication abortion have been approved by the FDA for many, many decades, based on mountains of high-quality evidence and expert scientific judgment. So, if you are confirmed, will you commit to upholding the science and evidence-based drug approvals for all FDA-approved products, including contraception and medication abortion?’
“You have my commitment to follow the independent scientific review process at the FDA, which is a tried and true process and has been around and so, that is my commitment to you, Senator,” Makary said.
“Well I want to be clear, there have been over 100 high-quality studies over more than two decades backing up the science and safety of mifepristone,” Murray concluded.
As a longtime appropriator and former Chair of the Senate HELP Committee, Senator Murray has a long history of demanding accountability and careful oversight when it comes to the safety of products families use every day. At the end of 2022, Senator Murray passed legislation giving FDA new authority to, for the first time ever, regulate the safety of cosmetic products and force a recall when necessary—and she successfully fought to secure funding for this important work last year as Chair of the Senate Appropriations Committee. Senator Murray has also previously pressed FDA and industry for answers and action regarding asbestos in children’s make up kits, demanded answers from Johnson & Johnson regarding asbestos found in baby powder, and was a leading voice in holding FDA accountable and pushing for solutions following the infant formula contamination and shortage crisis in 2022.
Senator Murray led her colleagues forcefully opposing the nomination of notorious anti-vaccine activist RFK Jr. to be Secretary of HHS and she has long worked to combat vaccine skepticism and highlight the importance of scientific research and vaccines. In 2019, Senator Murray co-led a bipartisan hearing in the HELP Committee on vaccine hesitancy and spoke about the importance of addressing vaccine skepticism and getting people the facts they need to keep their families and communities safe and healthy. Ahead of the 2019 hearing, as multiple states were facing measles outbreaks in under-vaccinated areas, Murray sent a carta bipartidista with former HELP Committee Chair Lamar Alexander pressing Trump’s CDC Director and HHS Assistant Secretary for Health on their efforts to promote vaccination and vaccine confidence.
Senator Murray leads the Democratic caucus on reproductive health care and, throughout her career, has beat back countless Republican attempts to defund Planned Parenthood and other family planning services—and is widely credited with successfully pushing the Bush administration’s FDA to follow the science and make Plan B available over the counter. Senator Murray led the response in Congress to FDA v. Alliance for Hippocratic Medicine, a lawsuit brought by Republican anti-abortion extremists trying to rip away access to mifepristone, a safe and effective abortion medication that was approved by FDA in 2000—Murray led múltiple amicus briefs, organized her colleagues, and elevado los alarm at every turn. Last June, the Supreme Court dismissed the case on standing groups but Murray made clear that “the nationwide threat to medication abortion has not gone away—far from it. If Donald Trump and his anti-abortion allies return to power, they will do everything they can to rip away access to mifepristone and ban abortion nationwide.” Murray también spearheaded efforts in Congress urging the FDA to follow the science and review the application of Opill, the first over-the-counter birth control pill, after the FDA’s Advisory Committee votado por unanimidad to recommend FDA approval.
###