Experts Debate Cost, Effectiveness of BTC Drug Class
Panelists at an FDA public meeting urged caution in creating a new class of behind-the-counter (BTC) drugs that would be available without a prescription but would require a pharmacist’s intervention.
Many speakers agreed that a BTC program would improve accessibility of medications to patients and allow manufacturers and the FDA to collect additional data on drugs, such as with Phase IV clinical trials. Suggested candidates for the potential new classification included OTC cough and cold medications for children, epinephrine injections, Tamiflu (oseltamivir phosphate) and oral contraceptives.
Others, however, said the program is unnecessary and would raise drug costs. “The two-class system works and it works well,” Consumer Healthcare Products Association Senior Vice President for Policy David Spangler said.
While the FDA is not putting forth a specific proposal for BTC drugs, it held the public meeting to get a sense of the challenges in creating such a program.
The effect of BTC drugs on healthcare costs was one area of disagreement, with some panelists claiming it would reduce physician visits and co-pays and prevent long-term health problems through increased drug access. Others said a BTC class would increase drug prices because of reduced competition in the OTC marketplace and the added cost of pharmacist involvement.
The FDA’s authority to create such a class also was debated. Joseph Cranston, director of science for the American Medical Association, said that while some agency officials believe language in the recent FDA Amendments Act allows the agency to create a new drug class, Congress has not discussed the issue. However, Philadelphia College of Pharmacy professor Daniel Hussar argued the agency already has the authority, noting that the FDA essentially gave Barr Pharmaceuticals’ Plan B emergency contraceptive BTC status.
The agency is accepting public comments until Nov 28. More information can be seen at www.fda.gov/oc/op/btc/.