PDUFA

In future posts I will detail more about the history of the FDA and its makeup, but I want to comment on the recent illuminating editorials published in this week’s NEJM.

Let me say first that I am not a Communist and I am not a believer that government can fix all of society’s ills. I like freedom in general and am not a fan of too much government interference.

Except in areas where an industry cannot police itself. For instance, it’s pretty clear after Enron and all of the post dating options scandals that Wall Street cannot police itself. Obviously they need MORE regulation, NOT less.

Well, when it comes to the drug approval process, I guess you could say it’s an argument between freedom to have access to drugs, and restriction in the name of public safety. It was an environment of lawlessness depicted in books like Upton Sinclair’s “The Jungle” that led to President Theodore Roosevelt signing the Wiley Act in 1906, which created the agency that eventually became known as the FDA. The need to prevent interstate adulteration of foods and drugs was rampant. The industry needed POLICING!

Fast forward to 1992, and things are a lot better. But the FDA is understaffed. Their budget is not large enough. Congress can only appropriate 125 million dollars for their “Drug Regulation and Safety” division, not nearly enough resources to adequately study all the new drug applications. Also, AIDS activists are demonstrating in Washington because they want access to new, potentially life-saving medicines, and the understaffed, under funded FDA is taking too long to approve these drugs. Whatever can be done to resolve this crisis.

Well, our 102nd Congress had an idea (majority of Senate were Democrats, by the way). They passed the Prescription Drug User Fee Act, or PDUFA. (I like to call it “P-douche-A). Thanks to this bit of legislation, the pharmaceutical industry would now be PAYING THE SALARIES OF FDA EMPLOYEES!! Let’s repeat that: the very industry that the FDA would be policing, was PAYING THEIR SALARIES! If anyone thinks this is a good idea, after this whole Ketek debacle, then I must be on the wrong planet. The act has a lifespan of five years and we’re currently on PDUFA III. But here’s what is key: even though we now know the FDA is in a sorry state in light of these troubling reports, Congress is going to do… NOTHING! In fact, according to the editorial, it looks like reapproval is a done deal once the act expires on September 30th. They love the idea of all that free money from the “user fees” (read: Pharma grift). But guess what? That money isn’t free.

I’ll talk more about PDUFA in future posts.