FDA Debates Behind-the-Counter Drug ProposalNov 17, 2007 | Parker Waichman LLP
The Food and Drug Administration (FDA) is considering a proposal to create a new class of drugs that could be sold by pharmacists behind-the-counter (BTC). These BTC drugs would be sold without a prescription, and include drugs such as birth control pills and cholesterol and migraine medicine. Unlike over-the-counter (OTC) medications, sale of this drug class would require patients to discuss purchases with a pharmacist.
Some drugs being considered for BTC sale include varenicline (Chantix), a smoking-cessation drug; epinephrine, for treating serious allergic reactions; oseltamivir (Tamiflu), for the flu; and statins, for the treatment of high cholesterol.
During a day-long public hearing Wednesday on whether to allow the BTC drug class FDA officials listened to arguments for and against the proposal by representatives of various medical and public interest groups. At day's end, FDA officials said they weren't ready to make a decision and wouldn't speculate on a decision timetable.
The FDA is looking to gather public feedback on whether BTC drug sales could benefit consumers before moving on; however, consumer and patient involvement in health care is driving the FDA's decision to consider BTC drugs.
According to the FDA, variations of BTC programs exist in other countries, including Australia, Canada, Denmark, Germany, France, Italy, the Netherlands, New Zealand, Sweden, Switzerland, and the United Kingdom. These countries allow pharmacist sale of BTC medications that treat self-diagnosed conditions and involve drugs with minimal side effect and overdose potential.
Among those in support of BTC drugs is the National Community Pharmacists Association (NCPA) whose support is prompted by the potential for increased patient access, reduced health care costs, and improved patient-pharmacist interaction. The NCPA also feels that making some drugs BTC offers patients easy, cost-effective treatment options that could reduce illness severity and increase overall workforce productivity.
The American Pharmacists Association (APA) supports BTC drug sales seeing the program as an opportunity for improved medication use and patient care and as a method by which druggists could be reimbursed by the health insurance industry for dispensing advice and medications to consumers. Insurers and third-party payers would pay pharmacists similar to how physicians are currently reimbursed for patient visits.
But not everyone supports the idea of BTC drugs – most prominently, the American Medical Association (AMA). The AMA does not endorse the plan on many levels. They do not agree that the FDA has legal authority to establish the BTC program without legislation; they do not feel there is a need for this form of medication dispensing; and they are concerned with the potential for drugs being moved to this class when diagnosis and physician management are called for.
Others feel that pharmacist counseling will be of great value in assuring the effective and safe use of BTC medications and will enhance pharmacist recognition as viable sources for information regarding other medications and health-care issues.
But opponents of the establishment of a BTC classes argue that pharmacists aren't qualified to sell medications, particularly statins. One of the concerns is how pharmacists will access the criterion involved in proper dosing. Without being able to order blood tests and with an inability to interpret the test, how will a pharmacist determine what drug and in what dosage is needed?