House Energy and Commerce Committee Requests that GAO Update 1995 BTC Drug Study Report

January 30, 2008

Earlier this month, U.S. House of Representatives Energy and Commerce Committee Chairman John Dingell (D-MI) and Oversight and Investigations Subcommittee Chairman Bart Stupak (D-MI) sent a letter to David M. Walker, Comptroller General of the U.S. Government Accountability Office (“GAO”) requesting that the Office update a 1995 report on Behind-the-Counter (“BTC”) drugs.  We previously reported that FDA scheduled a meeting for November 14, 2007 to discuss the possibility of creating a third class of drugs – in addition to prescription and over-the-counter drugs.  FDA did not put forth a specific proposal for consideration at the meeting, but instead convened the meeting to hear public suggestions as to how BTC “access can be structured and implemented in such a way as to increase access, benefit patients and improve public health.”  A copy of the November 14, 2007 meeting transcript is available here.

The 142-page 1995 GAO report, titled “Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet to Be Demonstrated,” was written after the GAO reviewed BTC drug distribution systems in ten countries and the European Union.  GAO concluded that:

Little evidence supports the establishment of a pharmacy or pharmacist class of drugs in the United States at this time, as either a fixed or a transition class. The evidence that is available tends to undermine the contention that major benefits are being obtained in the countries that have such a class. This conclusion is substantiated by six points.  (1) Reliable and valid studies that examine the effect of different drug distribution systems on overall health and health care system costs do not exist. (2) While a pharmacy or pharmacist class exists in all 10 countries, it is not used with any frequency in any of them to facilitate the movement of drugs to sale outside specialized drug outlets. (3) The European Union has decided not to impose any particular drug distribution system on its member countries because it has found no evidence of the superiority of one system over another. (4) There is no clear pattern of increased or decreased access to drugs as nonprescription products where a pharmacist or pharmacy class exists. (5) While a pharmacy or pharmacist class is assumed by some to improve safeguards against drug misuse and abuse, in the 10 countries these safeguards are easily circumvented, and studies show that pharmacist counseling is infrequent and incomplete.  (6) Experience in Florida with a class of drugs similar to a pharmacist class has not been successful; pharmacists have not regularly prescribed these drugs, and recordkeeping requirements have not been followed.

At the time, FDA provided only minimal comments on the report, stating that it “does not consider the additional requirements establishing a third class of drugs would impose upon the FDA, the drug manufacturers or the prescribing pharmacists.”

According to Representatives Dingell and Stupak, as a result of FDA’s recent discussion of BTC drugs, “it is imperative that more data be provided to assess accurately the true benefits, if any, of a [BTC] class of drugs.”  As such, Representatives Dingell and Stupak request GAO to update the 1995 report by conducting a “rigorous examination of any additional data since the original study that may allow us to evaluate the effect of a third class of drugs,” but without the on-the-ground investigations in foreign countries conducted to draft the 1995 report.

By Kurt R. Karst

Categories: Drug Development