The Food and Drug Administration now regulates about one-fourth of the goods in the American economy. That's a lot of stuff. The agency oversees biologics and drugs product approvals, labeling for a slew of medical products, medical product manufacturing standards for drugs, biologics, devices, the safety of the blood supply, the review and approval of devices, the safety and labeling of cosmetics, safety performance standards for radiation products, food labeling and food safety and of course, overseeing the way that manufacturers of medical products communicate about their products.
With all of this going on, it is sometimes hard to see the whole picture and to get an idea of how FDA is changing. I thought it would be handy to look at a few issues that are snapshots of where the agency might be headed – and yes, it is going to get even bigger:
- Regulatory Pathway for Biosimilars - The Patient Protection and Affordable Care Act, more commonly referred to as the health care reform legislation, included among other things provision for the FDA to create a regulatory pathway for biosimilars. There are a huge number of outstanding questions with respect to that pathway, especially around what types of work will biosimilar sponsors have to do in order to gain approval and how will the product be regarded with respect to the reference product it addresses. The process for answering these questions will likely involve some type of public hearing to collect commentary and input. The FDA has begun to assemble its internal infrastructure for overseeing the process, but change is not likely to occur for a matter of many months, leaving a key question – how will potential manufacturers of biosimilars bide their time on seeking approval if there is no process yet in place and will any submit an application – and what will FDA do if they do?
- Food Safety Bill – The FDA keeps saying that it needs more authority to prevent outbreaks of contaminated food illnesses and one would think, given the recent volume of outbreaks and recalls, that they would get it but for Senate inertia. S.510 – the Food Safety Modernization Act would broaden the FDA's authority by, among other things, allowing for the suspension of any food facility where there is a reasonable probability that it may cause adverse health consequences, inspection of manufacturer/processor records, and increases the capacity for such inspections and to improve the tracking and tracing of many agricultural products, which given the number of small growers, is a huge undertaking, and the bill would expand FDA's presence in foreign countries.
Then there are a few proposals that, if passed, would certainly increase the size and scope of the agency, except for the fact that they aren't exactly moving at the speed of light….
- Expanded Authority in Cosmetics – As noted a few months ago here, a new piece of legislation was introduced that would give the FDA more authority in the area of cosmetic regulation. The legislation, introduced by Congressperson Janice D. Schakowsky has acquired 11 co-sponsors and was only introduced in July. The bill would increase the level of information that has to be supplied by manufacturers on content and give FDA authority to initiate recalls of adulterated products. This legislation would bring cosmetics closer to the model that is sought for food with the Food Safety Bill, but it is an election year and if the food bill may not make it this year, don't look for any swift action on the cosmetics front. The bill has no related legislation.
- Supplemental Action on Supplements? Not likely. Introduced by Senator John McCain in February, S.3002 The Dietary Supplement Safety Act of 2010 has gone nowhere fast. It has acquired 1 co-sponsor. Of course, he had a rough primary season, but there is no impetus for this bill. The bill would give authority to issue recalls, fines to industry . The bill has no related legislation.
There is, of course, a great deal more going on at the agency that will expand both the breadth and depth of the FDA that runs across a broad spectrum of possibilities. Suffice it to say, that this already too large agency is going to continue to grow. And in our era of ultra-extreme risk aversion at all costs, there is indeed fertile ground for growth.