You are Entitled to Your Own Opinions, But Not to Your Own Facts
— A Tribute to Dr. Peter Marks —
If things went really bad at FDA, who would still be there at the end—caring enough about the agency and public health to keep fighting? My answer would be Dr. Peter Marks. I know you would agree.
Peter has been grace and integrity personified, as well as a defender of our collective faith in the value of data and science. Human betterment has always been Peter’s goal, regardless of where it led him. We should all adopt that same goal and that same attitude.
Peter’s leadership has spanned pandemic response, biotechnology, cell and gene therapies, blood products, rare diseases, regulatory science, vaccine development, and myriad other areas.
If something was a good idea—his or someone else’s—he has always been willing to pursue it. If you spoke, you always felt that Peter heard you, whether or not he agreed with you.
FDA is immeasurably worse for Peter’s departure, as are the American people. I worry—and you should too—that this is a harbinger of FDA’s fate: to be judged by individuals who do not believe in its fundamental purpose.
I do not think the details of Peter’s resignation matter. We can be fairly sure that he was asked to agree to some action—a statement, advice to the American people, or some study protocol—and felt his attempts to find common ground were not reciprocated. He refers to a commitment to truth and transparency and it is clear that he and the Secretary see these differently.
This was the culmination of a very bad week for FDA. I see two pressing needs.
First, it is important for FDA stakeholders to advocate for agency leadership that is empowered to act in the best interests of the American people. They need to be able to incorporate good policy, good medicine, and good science into agency decisions.
This falls to Commissioner Makary. He has been dealt a terrible hand, but that is all the more reason for him to act decisively to re-establish FDA’s credibility.
Second, the agency is being shattered by a RIF, made worse by the apparent absence of a plan to carry out FDA’s responsibilities with dramatically fewer staff. In a column yesterday, FAQ on FDA and the RIF, I pointed to a number of concerns that need to be addressed. It is particularly important to protect “review teams” and “inspection teams,” rather than just reviewers and inspectors. On this point, I said:
“…in practical terms, it would make no sense to protect a medical reviewer from a RIF, but not the individuals who the reviewer relies upon, such as a biostatistician. Likewise, an inspector in the field is of limited value without individuals processing, analyzing, and acting upon the inspector’s findings.”
The political landscape is such that it is unclear how to get things changed, with whom you have to speak, and with what message.
Let us pursue this, as a community, in the spirit that Dr. Marks has shown us—determined, caring, reasoned, unshrinking, and heedless to the odds when there is a right thing that needs to be done.