Food & Drug Adm: Drugs

Food and Drug Administration
Part II: Drugs

Today's Food and Drug Administration (FDA) began in 1927 as the United States Bureau of Chemistry which was reorganized into two entities: The "Food, Drug, and Insecticide Administration" and the "Bureau of Chemistry and Soils." In 1930 the "Insecticide" was dropped and the FDA was born and legitimized with the Food, Drug, and Cosmetics Act of 1931. Since then there have been numerous additional acts and amendments to bring us to present time.

While is is clear that the American public has been given the benefit of some of the safest drugs in the world it is also clear that politics, conflicts of interest, and poor understanding by the FDA of their real mandate have prevented the public from receiving much more from their government.

The Editor, on the basis of his personal experience with the FDA, has had a unique opportunity to comment on where we are and where we need to go.

There exists an unenviable legacy of toxic and dangerous drugs which have never been clearly identified as such but have "fallen into disuse" when the health hazards became so pervasive that they could not be denied. This situation has certainly not changed and the ill-advised epidural injection of Depo-Medrol serves as a shining example of a clear and present health-care danger not yet addressed by the FDA.

The saga of Thalidomide serves as an example of how not to do things. There is no question but that it was a highly toxic sleep drug in pregnant women. It is also clear that in other applications today it has been highly efficacious. That's the point. There is no drug that is all bad. There is failure in communication regarding the best and worst indications for use. No drug should be banned. What we need to ban is failure to adequately inform the public regarding objective information regarding drugs and allowing them to make the choice with consultation with their own physician. With today's high speed communication dissemination of this information is certainly possible.

The FDA simply has never understood that in its role is to protect the public interest and to do so they also have the charge to promote good information, to encourage the use of safe and effective drugs (even if they are industry "orphans") and create incentives for drug companies to produce "orphan" drugs, vaccines, etc. which are not profitable because of regulations and fear of litigation.

In all fairness the FDA requires the leadership, independence and resource to accomplish this and they have, in the past, been short-shrifted in these regards.

The recent fracas in regard to the Cox II inhibitory drug Vioxx is a perfect example of how not to do things. O.K., it has some serious cardiac-related side effects and this has not been adequately communicated to the public. It is also, however, an important alternative to Ibuprofen and Naprosyn for many patients.

The existence of safety issues is not adequate reason to ban these drugs. Making the public and the medical profession aware of this is the challenge. Another part of the challenge is holding those responsible for "off label" use more responsible for their actions.