FDA hears mixed views on third class of drugs

December 10, 2007

Pharmacists' organizations were out in force at a recent FDA hearing on the possibility of creating a third category of drugs that would be placed "behind-the-counter" and pharmacist-assisted.

Most of the 11 R.Ph.-related groups that testified emphasized that their members are educated and willing to do the counseling needed for several drugs the FDA might consider for such a category. But most groups also warned that pharmacists must be reimbursed for that work, to make the system effective.

Yet from consumer groups, medical groups, and others, the meeting heard a mixture of support, opposition, and pleas for more study on how such a system would work. The American Medical Association testified in scathing opposition to the proposal.

Daniel A. Hussar, Ph.D., of the Philadelphia College of Pharmacy, told the FDA officials, "The access of patients to medications from which they can benefit will be markedly increased" by decisions to place drugs in such a category. "Many individuals rarely if ever see a physician unless there is some emergency.... The BTC availability of certain medications from a pharmacist will not only be of value in the treatment of conditions for which physician consultation is not necessary, but it will also facilitate and increase the referral by pharmacists of patients with potentially serious problems to physicians," he said.

Hussar also asserted, "Pharmacists are well prepared and strategically positioned to review clinical laboratory test results; identify contraindications, drug interactions, and other drug-related problems; counsel patients on the appropriate and safe use of medications; and monitor for continued safe and effective use."

Michael Moné, director of regulatory compliance for Medicine Shop International, testified on behalf of the American Pharmacists Association. He said that "BTC medications that require a pharmacist's clinical intervention would facilitate more pharmacist-patient communication that would ultimately lead to improved medication use outcomes and improved public health."

Among other pharmacy-related groups supporting the concept were ASHP, the National Association of Boards of Pharmacy, and the National Community Pharmacists Association.

More evidence needed?

On the other hand, Sidney Wolfe, M.D., director of Public Citizen's Health Research Group, said, "There needs to be evidence not currently available ... that benefits do outweigh the risks of such a new system." He asserted that new legislation would probably be needed to create such a system.

Joseph Cranston, Ph.D., AMA's director of science, research, and technology, said that the association was perplexed as to why the hearing was even being held, saying that the law under which the FDA operates creates two classes of medications, and there is no support in statutory language for a third class. "While pharmacists are very knowledgeable about drugs, they lack the necessary education and experience in patient evaluation, clinical diagnosis, and prescribing for individual patients," he said.

Michael Greene, M.D., a Harvard Medical School professor, testified on behalf of the American College of Obstetricians & Gynecologists. He said ACOG wanted to take a nuanced view. "We recognize the potential advantage of increased access compared with prescription status, and are concerned about the decreased access compared with over-the-counter status," he said. However, he said, given that half of U.S. pregnancies are unplanned, ACOG has many concerns about counseling and monitoring for current or future pregnancy. He suggested that with a BTC system, R.Ph.s might take on more pregnancy-related liability issues than they realize.

Other questions that came up at the hearing-characterized as a beginning conversation on the subject-were whether the BTC category would or should become a transitional status for medications moving from prescription to OTC or vice versa; whether such a class might be used to limit access to medications that would otherwise be OTC; and whether it could be "misused" for "political" purposes, as some groups asserted was the case in the placement of Plan B behind the counter.

THE AUTHOR is a writer based in the Washington, D.C., area.