Buying Patient Opinion at FDA Advisory Committee Meetings is the Norm
​[Thursday, February 13, 2020]
Patient presentations at FDA Advisory Committee meetings are very important for swaying the votes of reluctant jurors to vote in favor of approval. Almost none of the patient presentations are against the drug under review and all of them are paid for by the company who product is being debated by the Advisory Committee. A recent report analyzed the trends of patient presentations at Advisory Committee and found several questionable practices used by companies to bring favorable patient advocates to plea on their behalf. It could be something as simple as reimbursing patients for travel or paying them as consultants. And this practice is not limited to Advisory Committees. Companies use it for all kinds of interactions with the FDA. Companies teach friendly patients about the intricacies of FDA process, help organize meetings with FDA management in the name of patient-focused drug development efforts, and get patients to make high profile emotional testimonials and speeches, all with the goal of getting a positive decision from FDA.   The practice of involving patients for advocacy of products with questionable benefit is particularly effective since the only way to persuade FDA is to emphasize the “other benefits” of approval when the effectiveness data is lacking. Processes to involve patients in regulatory decisions were created to give patients voice in the regulatory decision process but it is getting hijacked by the industry, and to a large extent patient groups are to blame. Patient advocacy has played a very important role in the past to get FDA to find ways to get new products approvals when traditional approaches did not work. This was effective in the 90s for the HIV drugs, and the last two decades for the cancer drugs and orphan drugs. But what was once an effective way to humanize the drugs being reviewed by the Advisory Committees, is now a tool for exploitation of emotional situations for positive regulatory opinions and the related financial windfalls. Patient groups are swayed by sponsors who literally pay to get positive feedback and support. Patients making presentations at Advisory Committees are not required to disclose conflict of interest, but it should be. In an ideal world, FDA should be required to assure a balanced patient presentation even from those that do not agree with the drug approval. But that’s practically not feasible. So, we are left with a convoluted process that aims to make it fair for the patients but probably is getting exploited as a loophole.