RELEASE: Congressman Auchincloss questions Secretary Kennedy on FDA whistleblower disclosures, White House fast-tracking of psychedelics
FOR IMMEDIATE RELEASE:
Contact: Georgina.Burros@mail.house.gov (Auchincloss)
WASHINGTON, D.C. – Today, Congressman Jake Auchincloss (D, MA-04) questioned Health and Human Services Secretary Robert F. Kennedy Jr. at a House Energy and Commerce Health Subcommittee hearing about the recent decision by the Food and Drug Administration (FDA) to fast track three approvals for psychedelics under the Commissioner’s National Priority Voucher (CNPV) program, based on a text Joe Rogan sent to President Trump. One of these psychedelics was previously denied by the FDA in 2024.
Representative Auchincloss has dialed up the pressure on Commissioner Makary for months regarding his CNPV program, which has allowed for accelerated drug and biologic approvals not for the most promising scientific discoveries, but for companies with ties to MAGA.
Please find below the full disclosures from current and former FDA staff Rep. Auchincloss shared today, as well as a portion of Rep. Auchincloss’ exchange with Secretary Kennedy.
These disclosures from current and former FDA staff shared with the congressman’s office support public reporting of political pressure at the FDA:
1. “Over the past year, FDA career staff have been alarmed and demoralized by the reckless changes at our Agency. This administration has approached FDA with a fundamental suspicion of career staff and with an appalling focus on ‘media wins.’ These ‘media wins’ have been anything but wins for our Nation’s public health. Rather than the purported ‘gold standard science’ FDA staff have been subject to a steady, unrelenting compromise of our scientific standards to support ideologically driven policy goals, and to promote the careers of short-sighted political appointees, who are more focused on media sound-bites and their own self-promotion than our Nation’s health.”
2. “Dr. Makary began his FDA tenure with the promise of upholding principles of gold standard science, radical transparency, and common sense. In addition, based on his public positions regarding inappropriate influence of the pharmaceutical industry on the Agency, he had the promise of upholding the independence of FDA scientific decision making and keeping the Agency free of corruption.
In practice, Dr. Makary's tenure has been essentially Orwellian in nature, going directly against his stated principles every day while obsessively focusing on his external image. Rather than pursuing gold standard science, his appointees in senior leadership roles start with the conclusion and search for evidence to support it. Rather than convening panels of external scientific experts with a range of perspectives, he convenes so-called "expert panels" with cherry-picked panelists who share his opinion. In contrast to radical transparency, he works in siloed and secretive groups with very limited input from staff scientists, and career staff learn about new policies after they are announced in press releases or journal articles. In contrast to common sense, he appoints people to senior scientific leadership positions based more on loyalty to him and being a good soldier, regardless of their qualifications or competence to do the job. And rather than reducing potential corruption from industry, his approach has made direct lobbying to the Commissioner's Office a smart and productive business practice for companies to get what they want, favoring companies that are more politically connected.
The end result of his disastrous leadership is a chaotic and unpredictable FDA that makes decisions based on politics and is bleeding leaders with principles and scientific neutrality. This is completely unacceptable for a premier public health agency that is expected by the American public to ensure safe and effective medical products and other products under its regulatory purview.”
3. “I recently left FDA due to the political pressure I was receiving to withhold my recommendation for approval for a drug that was intended for a rare disease. I was part of a review division that was constantly under pressure. Specifically for this recent example, we met frequently with Prasad and other FDA leadership who emphasized the drug should not be approved. However, from the review document and my experience, it would have been approved had it not been for the political pressure.”
Please find the full video of Rep Auchincloss’s exchange with Secretary Kennedy here.
Secretary Kennedy: I can tell you that all the decisions that have been made at that agency are made with the approvals of panels of career scientists.
Auchincloss: That's just not true. So let me reclaim my time. That is categorically false, because there is, in fact, a program called the Commissioner's National Priority Voucher Program. I've been investigating that as well for the last six months. This program expressly allows political leaders to short-circuit science and pick and choose politically favored treatments. Now, White House and FDA leadership have pressed staff to award vouchers to certain companies as part of White House pressure campaigns. Most recently—and egregiously—the FDA just issued three of those vouchers for psychedelics based on a text from Joe Rogan. And one of those psychedelics was denied by the FDA in 2024.
So let's just go through what happened here. Joe Rogan had a guest on his podcast, and the guest was talking about psychedelics. Joe Rogan texted the President of the United States, and the President texted back: “Sounds great. Do you want FDA approval? Let's do it.” That was from the President of the United States.
So just to be clear, is the President of the United States allowed to grant FDA approval?
Secretary Kennedy: The career staff—
Auchincloss: Is the President of the United States allowed to grant FDA approval?
Secretary Kennedy: Career staff at FDA have all supported that decision.
Auchincloss: Is the President of the United States allowed to grant FDA approval? Because he thinks he is. Is he wrong?
Secretary Kennedy: He doesn't do it.
Auchincloss: He doesn't do it. So—and yet the FDA, within hours—
Secretary Kennedy: There's been no FDA approval—
Auchincloss: Issued three priority vouchers from this illegal, unauthorized program to respond to political pressure from the White House. Secretary, this flies in the face of your stated commitment to putting science over politics.