Just as one division of the Food and Drug Administration plans to slow down approvals of new and updated vaccines, another division’s leader is planning to resign over concerns that new drugs are being reviewed and approved too quickly.
Dr. Richard Pazdur has served as the director of the FDA’s Center for Drug Evaluation and Research for only the past few weeks. His division is responsible for reviewing and approving most over-the-counter and prescription drugs. Now, the Washington Post reports that Pazdur plans to resign:
In a previous article, the Post described how Pazdur had taken issue with the Trump administration’s initiative to accelerate drug-review times from ten to twelve months to just one to two months for pharmaceutical companies found to be “supporting U.S. national interests”:
Pazdur has also raised concerns about Makary’s new drug-review program, which has been part of Trump’s push for lower drug prices and efforts to boost domestic manufacturing. Pazdur told colleagues the program — which allows the agency to significantly shorten review times and expedite approvals for treatments that are aligned with the country’s health priorities — is not sufficiently transparent and could be illegal, the people said. The Trump administration has partly leaned on the program as it seeks to strike deals with drug companies to voluntarily cut their prices in exchange for quick drug approvals and other benefits.
This program — giving vouchers for expedited drug review to certain companies the government favors — is a big part of how Trump cajoled Eli Lilly and Novo Nordisk to offer their GLP-1 weight-loss medications at a discount earlier this fall. The administration is also offering vouchers to firms that promise to re-shore manufacturing and development operations to the United States. It’s right in line with Trump’s retail dealmaking approach to public policy.
What it’s definitely not, though, according to proponents’ own standards, is MAHA. A principal complaint of the MAHA movement — spearheaded by the man who now oversees the FDA, by the way — is that the FDA has not applied enough scrutiny to new drugs before allowing them on the market. Advocates denounced the Covid vaccine precisely because they thought the FDA approved it too quickly. An RFK Jr. ally in the FDA, Vinay Prasad, is planning to slow-roll vaccine approvals based on the same fear.
In my view, there is little wrong with the FDA accelerating the review of new drugs — though if the agency can do so, it should offer quicker reviews to all developers, not just the ones the president prefers. But MAHA should be appalled by this: Pharmaceutical companies are literally cutting deals with the federal government to get their new drugs approved faster and with less scrutiny.
Isn’t that what RFK Jr. and his friends have been denouncing this whole time?