GAO Issues Report on BTC Drug Category; Update of 1995 Report Could Lead to Legislative Proposal

March 31, 2009

By Kurt R. Karst – 

Last week, the U.S. Government Accountability Office (“GAO”) issued a report, titled “Nonprescription Drugs: Considerations Regarding a Behind-the-Counter Drug Class.”  The report updates the Office’s 1995 report on the same topic (see our previous post here).  The updated report was requested by Representatives John Dingell (D-MI) and Bart Stupak (D-MI) in January 2008 after FDA held a public meeting in November 2007 on Behind-the-Counter (“BTC”) availability of certain drugs.  A copy of the 2007 FDA meeting transcript is available here.  FDA has previously considered and declined to create BTC drug status.  Specifically, in April 2004, FDA denied – without substantively discussing BTC status – a citizen petition requesting that the Agency “switch Nicotrol Inhaler (Nicotine Inhalation System) from prescription only to over-the-counter status TO BE SOLD ONLY UNDER A PHARMACIST’S SUPERVISION as a third class of drugs.” 

According to the GAO report, there are two general views on how a BTC drug class would be used in the U.S.  The first view is that BTC drugs would be a permanent drug class – similar to the current prescription and Over-the-Counter drug ("OTC") classes – insofar as there would be no expectation that BTC drugs would eventually switch to the prescription or OTC class.  The second view is that a BTC drug class would function as a transition class for some drugs and a permanent class for other drugs, such that “[a] drug being switched from prescription to nonprescription would spend time in the transition class, during which the suitability of the drug for OTC status could be assessed.”

The 1995 GAO report concluded that “[l]ittle 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, and that “[t]he evidence that is available tends to undermine the contention that major benefits are being obtained in the countries that have such a class.”  The bottom line in the 2009 report is less clear, presumably because the focus of the report was to describe arguments supporting and opposing the creation of a BTC drug category, evaluate BTC drug systems in five countries that have evaluated drug classification since 1995 (i.e., the U.S., Australia, Italy, the Netherlands, and the United Kingdom), and note issues important to establishing a BTC drug class in the U.S.  The GAO report concludes that:

Arguments supporting and opposing a BTC drug class in the United States have been based on public health and health care cost considerations, and reflect general disagreement on the likely consequences of establishing such a class.  Proponents of a BTC drug class suggest it would lead to improved public health through increased availability of nonprescription drugs and greater use of pharmacists’ expertise.  Opponents are concerned that a BTC drug class might become the default for drugs switching from prescription to nonprescription status, thus reducing consumers’ access to drugs that would otherwise have become available OTC, and argue that pharmacists might not be able to provide high quality BTC services.  Proponents of a BTC drug class point to potentially reduced costs through a decrease in the number of physician visits and a decline in drug prices that might result from switches of drugs from prescription to nonprescription status.  However, opponents argue that out-of-pocket costs for many consumers could rise if third-party payers elect not to cover BTC drugs. 

The GAO report also goes on to comment that “[a]ll five study countries have increased nonprescription drug availability since 1995; however, the impact of restricted nonprescription drug classes on drug availability is unclear.”  The report also identifies several issues that need to be addressed before a BTC drug class is established in the U.S.  In particular, the GAO report states that:

Pharmacist-, infrastructure-, and cost-related issues would have to be addressed before a BTC drug class could be established in the United States.  The roles and responsibilities of pharmacists in a BTC drug class that would need to be considered include defining pharmacist responsibilities for dispensing BTC drugs, ensuring that pharmacists provide the necessary BTC counseling, and determining whether additional training would be needed for pharmacists and pharmacy staff.  In addition, whether or not there is a sufficient pharmacist workforce to make such a class viable would need to be determined, and pharmacists’ new role would need to be communicated to the public. Ensuring that pharmacies have the data infrastructure necessary to provide pharmacists with patient information and the physical infrastructure to protect consumer privacy would also be important.

Whether the GAO’s report will lead to the introduction of legislation to create a BTC drug class remains to be seen.  Legislators are presumably reviewing the report in detail to gauge the need for and the potential impediments to the creation of a BTC drug class. 

Categories: Drug Development