Editor's Note: Antiepileptics Controversy Highlights FDA's Problems

Author: Fred M. Eckel, RPh, MS



Mr. Eckel is professor and director of the Office of Practice Development and Education at the School of Pharmacy, University of North Carolina at Chapel Hill.



A recent controversy has highlighted an all too familiar issue?whether the FDA is currently capable of effectively evaluating and regulating drugs.

The controversy rages over generic substitution of antiepilepsy drugs. Some groups, including the Epilepsy Foundation, feel that generic antiepilepsy drugs may differ significantly from brand name drugs and may not provide the same level of protection. As a result, these groups are trying to drive antisubstitution laws through many state legislatures. Most of this proposed legislation would prevent pharmacists from substituting a generic without first obtaining physician approval.

This has spurred vehement protests from progenerics groups. Some question whether this is a real problem and note that supporters of the bills are funded by the pharmaceutical industry.

A number of state pharmacy organizations have also publicly opposed the legislation, pointing out that physicians already can specify, when writing the prescription, that no substitution should take place.

This may be a complex issue. Some neurologists say that the substitution of antiepilepsy drugs is particularly sensitive because of the narrow margin of safety. They say that even small variations in the product can potentially have serious consequences.

Clearly, drugs should not be inappropriately substituted. Once a patient is stabilized on any specific medication, we should not switch manufacturer sources without careful consideration. As pharmacists, we need to make sure that we are doing the right thing, before we consider whether others are at fault.

When considering this highly charged topic, it may be helpful to step back and view it from a broader perspective. Two questions spring to mind: (1) is this an issue that should be decided in state legislatures? And (2) should we apply a separate process to determine the rules for one specific group of drugs?

The answer to both of these questions is no. This issue should not be decided state by state; it is the FDA's responsibility to evaluate the safety of all drugs. It is not hard to imagine that if a separate process is established for one group of drugs, we might see calls for separate treatment of other drugs.

The fact that the issue has reached state legislatures is an indication that current regulatory processes are not working?or at least they are perceived not to be working. This might be an argument for providing the FDA with the resources and capabilities needed to do a more effective job. Imposing additional state regulations would only add bureaucracy and limit our ability to exercise professional judgment.