My first FDA Advisory Committee meeting – refreshing change from CT

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I was recently appointed as a consumer representative to the FDA’s Anti-Infective Drug Advisory Committee and yesterday was my first meeting. It was a bit intimidating to open the Wall Street Journal that morning to see an article about our meeting. It was fascinating – I learned more new things yesterday than I did all last year. The committee advises the FDA about new antibiotics with a deep dive into science and clinical trials on effectiveness and safety. Drug resistant bacterial infections affect 2 million Americans each year, killing 23,000, according to the CDC. There are 45 new antibiotics in the pipeline and yesterday we considered two of them. We heard from a small army of very impressive, dedicated, extremely well prepared experts, from both the FDA and the applicant drug companies, who answered every question the committee posed. The room was packed. We heard very moving public comment from families and patients affected by MRSA and from researchers concerned about protecting the public.

But the most striking thing, for a CT advocate, was the FDA’s discipline around ethics. Applicants to FDA committees complete a thick stack of documentation to ensure no conflicts of interest. The only voting members of the committee are independent clinical/academic experts, agency experts and consumer representatives. This may sound strange to anyone in CT policymaking, but they are very strict that drug companies do not vote on or influence the regulations they operate under. Weighing the best interests of consumers was the only priority – for everyone at the meeting. In CT we routinely have industries at the table, and people with financial interests in those industries, usually dominating the membership. In CT, industries are making decisions about what standards they have to reach, what they can charge, and how they will be monitored (if at all). Consumers and advocates have to fight our way into the process — preferably at the table, but if necessary by other means – and we are punished for it. The entire day I never heard about how our or FDA’s decisions would affect jobs or stock prices. It just never came up – protecting people and saving lives is the only priority.