Henry Miller about FDA Over-regulation

Dr. Henry Miller, writing in TCS, argues that the FDA has over-reacted to problems with drug safety by excessive regulation:

In spite of increasingly more powerful and precise technologies for drug discovery, purification and production, during the past twenty years development costs have skyrocketed. The trends are ominous: The length of clinical testing for the average drug is increasing, fewer drugs are being approved, and the number of applications to FDA by industry for marketing approval has been decreasing for more than a decade.

In January, the FDA announced new initiatives directed at the safety of new drugs, including a plan to perform a comprehensive assessment of the safety of some new drugs within 18 months after their introduction, and to issue a "report card" on their performance. Although this may sound plausible, it appears to be inconsistent with data which show that in fact newer drugs confer an advantage over older ones in reducing mortality. In a study of patients who took drugs during January to June 2000, those who took newer medications were less likely to die by the end of 2002. The estimated mortality rates were directly related to time that had elapsed since approval of the drugs: For pre-1970 drugs, the estimated mortality rate was 4.4 percent, while the mortality rates for drugs approved during the 1970s, 1980s, and 1990s were 3.6 percent, 3.0 percent, and 2.5 percent, respectively. Not surprisingly, drugs are getting better all the time.

A related point is the myth, often cited as fact by regulators and members of Congress, that rapid advances in science are outstripping regulation. Although some fields, such as human gene therapy, offer significant challenges, innovations such as improved gene-splicing and separation and analytical technologies have led to the manufacture of more highly purified drugs - especially vaccines, hormones and antibody preparations - which are less problematic for regulators.

Read the whole thing. (It is the first of a two part series.)

It is a fine line to walk between protecting the public and excessively regulating, and in my experience bureaucracies are barely ever capable of walking fine lines. I am sympathetic to the difficulty they are facing, but still I think that the FDA has reacted to the misdeeds of a small number of companies involving a small number of drugs with blanket regulations affecting all companies and all new drugs.

This will inevitably make it tougher to approve new drugs. And it is important to recognize that lengthening the process of drug approval does result in lost lives. There are no cost-free regulatory decisions.

In general, I think a more productive policy would be placing more power in the hands of doctors and patients. It is important for the FDA to make sure that they have all the information, but past that I don't think they should be impeding doctors from prescribing drugs that they believe will work and that the patient makes an informed decision to take.