On May 3 and 4, the Petrie-Flom Center for Health Policy, Biotechnology, and Bioethics at Harvard Law School presented a conference, “The Food and Drug Administration in the 21st Century”. The Conference drew about 240 attendees but surprisingly very few FDA staff, especially given FDA’s revived interest in regulatory science–only five were listed on the official registration list. During these two days, FDA and its policies were looked at largely from an academic perspective, and new viewpoints were presented for changing how FDA has done its business. A wealth of resources from the Conference may be found at the Conference Dropbox, including many speaker papers and slides.
Peter Barton Hutt, Partner at Covington & Burling LLP, kicked off the conference with a historical perspective of FDA over the past 50 years. Hutt traced back to 1962, when FDA focused on foods and was an obscure, unknown agency. At this time, the Commissioner made all the decisions, largely from a purely management-type analysis, and no issue “lasted longer than a week.” Hutt recounted the incredible increase in FDA staff over the years, particularly in recent years, where he views there are increased opportunities for FDA losing control and making inconsistent decisions and mistakes, as policy is made at the bottom of the agency, not the top. Hutt described how over the years, FDA has made creative use of its regulatory authorities. Initially, FDA first explained itself in extensive preambles to regulations proposed and promulgated in the 1970s. When issuing new regulations became too cumbersome, FDA took to issuing its policies in guidances.
Hutt noted how despite FDA’s increasing regulatory responsibilities, most recently including tobacco and biosimilars, Congress has continued to inadequately fund FDA, especially in recent years, which has resulted in certain regulatory distortions. In the 1990s, the innovator drug industry agreed to pay user fees to reduce review times, first from innovator drugs in the 1990s and now encompassing biologics, medical devices, and animal drugs and just last year biosimilars and generic drugs. Hutt observed that despite FDA’s growth and new user fees, historically there were more enforcement actions when FDA was much younger back in 1938, suggesting that other factors are at work making the process less efficient. Adding to that, Hutt described FDA’s budget as “essentially flat” except for the influx of more user fees, which permits program with user fees to “thrive” while other programs are hurt, languish, or are forgotten. For example, the Drug Efficacy Study Implementation (“DESI”) program begun in 1962 to review efficacy for all drugs on the market is still not complete, the over-the-counter drug program begun in 1972 is only 75% complete, medical device reviews of all class III devices begin in 1976 is not complete, and FDA gave up without explanation on the food ingredient program begun in 1969 to review ingredients generally recognized as safe (“GRAS”). Meanwhile, programs funded by user fees (but not other programs) get a chance every five years to get additional statutory support from Congress, when the user fees and timelines for FDA review cycles are up for discussion.