As mentioned last week, compromise legislation passed that is bringing a 5-year extension of PDUFA is also bringing with it a codification on reducing real or perceived conflict of interest rules for members of FDA advisory committees.
The legislation sets up a formula that reduces the number of advisory committee members with conflicts by a set percentage each year.
But according to reporting in the Boston Globe, the FDA is considering its own efforts at reform by revising its approach to committee membership to weed out those advisors with a potential conflict of interest.
This raises a number of questions. First, in my mind, is whether or not the conflicts are real or are perceived in terms of their effect. The article notes that a study by Public Citizen did not find any real difference in outcomes when looking at the conflicts of interest from past panels. In that study, the organization found that there was "a weak but statistically significant relationship between certain conflicts and votes in favor of the drug under consideration." I’m not sure what that means, if something is weak, but statistically significant – is it worth worrying about or not?
The other important question is how the FDA is going to augment what is already being mandated under the legislation, related to reform of conflict of interest rules? There is no mention in the Boston Globe article of a defined process or time frame for considering further reform.
It should be an important goal of the FDA to repair its image by bolstering public confidence in the advisory committee process. However, a recently reported poll by the Center for Congressional and Presidential Studies at American University demonstrated that the public is generally confused about the agency’s role in drug safety. My feeling is they are probably even more confused about the role of the agency and food safety. But that aside, it might be that this survey provides some clues into how the agency should begin the reform process and that is by educating people about the status quo and the perceived problems that exist in order to make the solution of reform meaningful.
Everyone wants an un biased Ad Comm. Some think that if you only recruit those without drug company funding, you’ll achieve that result. However, it is more likely that you’ll end up with a bunch of people on your committee with no drug development experience, which is probably NOT what anyone wants.
I couldn’t agree more. I would much rather have someone who understands drug development first-hand than someone operating from the theoretical level. Or worse, someone with an agenda that is biased against new compound development.