We’re well on our way into the Petrie-Flom Center’s Annual Conference, FDA in the 21st Century, and we’ll be live blogging the sessions today and tomorrow here at Bill of Health.
Today’s sessions opened with a fantastic plenary from Peter Barton Hutt, who’s had more than five decades of experience with Food and Drug Law, including 4 years as Chief Counsel to the FDA.
Peter addressed a wide variety of topics in his talk on “Historical Themes and Developments Over the Past 50 Years.”
1. FDA Management
Peter discussed various management approaches utilized by different FDA commissioners over the years, from Commissioner Edwards in the 1970s who ran the agency like a management consultant, meeting with every Center every week, to Commissioner McClellan who viewed his post through the lens of an economist. Different management styles have been needed as the agency has grown tremendously, from 6,500 employees in 1976 to a $4 billion appropriation and more than 12,000 employees today. As a result of that growth, the Commissioner and Center directors necessarily know less and less about what the organization is doing. This creates tremendous possibilities for inconsistencies, mistakes, and loss of control, and ultimately, policy is now made from the bottom-up.
Peter described the fundamental shift in FDA’s approach to rulemaking over its history. Before 1970, the agency relied heavily on a combination of guidance and litigation, primarily as a result of the fact that the four general counsels in that role from 1906 to 1971 were all litigators, and viewed lawsuits as the appropriate way to develop government policy. It became clear in the 1970s that this approach couldn’t work for everything, and as a result, the agency reinterpreted an obscure provision of the Act allowing it to issue regulations for “efficient enforcement” of the law to permit substantive rulemaking, rather than just procedural rules. This allowed huge programs to be created administratively, from nutritional labeling to OTC drug review to FOIA regulations. Equally important was FDA’s approach to developing lengthy explanatory preambles to its regulations.
As Congress made the promulgation of regulations more difficult by requiring environmental impact statements, analyses of impact on families, and the like, FDA has moved back to a system of relying heavily on guidance documents – and today, guidance is the primary way FDA makes policy. There are more than 2000 draft and final guidance documents, which industry treats as having the force and effect of regulation, even if FDA cannot enforce them in the courts.
Next, Peter moved on to discuss FDA’s approach to enforcement over the years. In 1938, for example, the agency initiated more than 2000 seizure actions and 725 criminal prosecutions, whereas in 2007, it conducted only 6 seizures and no criminal prosecutions through its field office. Despite this dramatic shift, Peter argued that FDA has become far more effective by switching its enforcement activities to the realm of administrative action, such as warning letters and recalls. He noted that the premarket approval process, regulations, preambles, and guidance have collectively taken out of the courts many issues that the agency would have formerly litigated.
4. Impact of user fees
A highly controversial area, Peter explained that FDA originally opposed user fees, arguing in addition to fears about apparent conflict of interest, that their mission helps the entire public, not just industry, and thus agency activities should be paid for out of appropriations. However, by the 1990s, it became clear that if FDA relied on appropriations alone, Congress would not fund the agency adequately, and the agency changed its tune. Industry also supported this approach, for the simple economic reason that to the extent a new drug can get through the regulatory process more quickly, even by a short period of time, the industry will recoup its user fee and more.
We now have user fees for drugs, devices, generics, animal drugs, and several other regulated products. Often unaddressed, however, is the impact of these user fees on other programs, such as OTC drug review, which remains inadequately funded. Thus, there is now a problem of “haves” and “have nots” within the agency.
5. Legacy Programs
Peter briefly addressed the variety of tasks that have been assigned to FDA by Congress that the agency has simply failed to complete over the course of several decades. For example:
- Despite its enactment in 1960, FDA still has not fully implemented the Color Additives Amendment
- In 1962, Congress ordered FDA to review all of the pre-1962 NDAs, but FDA has still not completed that job
- In 1972, FDA created the OTC Drug Review, which remains only 75% complete
Why are these programs failing? Peter attributes the problem to a variety of factors, including the fact that these mandates were inadequately funded by congress, they have no associated user fees to allow the job to get done, and as each new Commissioner has taken over, they’ve had their own new priorities to focus on.
6. Science v. Policy
Peter closed on the question of whether FDA should be viewed primarily as a science agency or a law/policy agency. He argued that it is in fact both, and gave a few examples:
- On the decision regarding switching Plan B from prescription to OTC status, the agency must consider two factors under the statute: (1) toxicity, which is clearly scientific, and (2) collateral measures necessary for the drug, which is clearly a matter of policy judgment.
- And with regard to the basic convention of assuming statistical significance at a confidence level of .05, which is generally treated as a scientific matter, Peter pointed out that selection of .05 rather than .01 or .1 is a policy matter based on how much confidence we feel is necessary.
* * *
During the Q&A period, Peter spoke further about the decision regarding Plan B, the possible influence of user fees on the agency, the use of warning letters, the possibility of addressing sodium through GRAS standards v. reliance on the “poisonous and deleterious” language in the statute, inconsistencies within various centers and institutions within the agency, and the impact of globalization on FDA’s current mission.
Stay tuned for more from the conference!