It sounds like the FDA is going to be one of relative winners on Capitol Hill when it comes to budget requests for Fiscal Year 2012. While many government agencies are under pressure to scale back, even the Department of Defense is in saving mode and poor NASA has just about given up on getting us to Mars anytime soon, folks we’ve talked to expect the FDA to get pretty close to its modest increase request.
That’s good news in many ways, perhaps even for those who don’t like the FDA having too active role in their lives (hello Medical Device companies).
The reason: Congress and others have “been asking the FDA to do a heck of a lot of stuff without a heck of a lot of money,” notes industry expert Mark Mansour, a partner at AkinGump and fellow AssurX blogger.
Mansour’s logic, and I’ve heard this now elsewhere, is that a better funded FDA will do a better and more consistent job when it comes to regulating food, drugs and medical devices. Much of the complaints I hear about dealing with the FDA, especially from device companies, is that they never know what to expect from one inspector to the next. Or even that FDA focus can change mid-inspection either because an inspector has left or something else changed at the FDA’s end.
In addition, the FDA is getting pressure from folks on Capitol Hill who believe medical device innovation in particular is moving to more friendly regulatory climates such as Europe. “Medical device investors feel they can get a more predictable approval process over there,” Mansour adds.
FDA is also struggling to replace outgoing senior inspectors and other knowledgeable personnel. It takes years for a new FDA inspector to come up to speed. Think baseball where even a phenom like Washington National Bryce Harper isn’t an instant major leaguer, rather than say football where a top draft pick can be an immediate star in the pro’s, which is what the Washington Redskins are banking on with Robert Griffin.
It may be hard for medical device manufacturers and others to hear, but giving the FDA more budget might be good news for everyone.
More money won’t solve everything, of course. The FDA has some organizational and strategic priority choices to confront and reconsider, in addition to getting new people up to speed, and it also needs to work on bringing its medical device class and subclass system into the 21st century, Mansour adds.
But even in these days of cutting political partisanship, almost everyone echoes Mansour, “All agree the FDA’s function is critical.”