WASHINGTON (FNS) -- Two advisory committees to the Food and Drug Administration have postponed a review of whether acyclovir should be switched from prescription to over-the-counter for treating genital herpes.
The committees were scheduled to meet on July 28. However, acyclovir's manufacturer, Burroughs Wellcome, Research Triangle Park, N.C., has requested more time to submit data. Once the advisory committees make their recommendation, it's up to the FDA to accept or reject it.
If FDA decides at a later date to approve the switch of 200-milligram acyclovir to OTC status, it would be the first time a medication for an infectious disease was made available without a prescription. It would also be a boon for Burroughs Wellcome. Acyclovir, which Burroughs Wellcome markets as Zovirax, rang up $440 million in prescription sales last year. It is covered by a patent until 1997.
An estimated 55 million people, or one in five Americans, are infected with herpes and an estimated half-million new cases are expected to occur this year. Only about 11 million sufferers experience periodic outbreaks of herpes lesions. The balance of infected people don't have symptoms and are typically unaware they carry the disease.
Strong opposition to the switch was voiced by a pharmacy representative, speaking on behalf of the American Society of Hospital Pharmacists, at a public hearing held May 19 before FDA officials. ASHP was the only national pharmacy organization to present oral testimony.
Kathryn Bucci, Pharm.D., associate professor of family medicine and clinical associate professor of pharmacy practice and administration at the Medical University of South Carolina/Self Memorial Hospital, Greenwood, cautioned against permitting unrestricted distribution of any oral antimicrobial drug. "The potential for the development of drug resistance is significant," she said.
Other concerns raised by Bucci included the potential for other infections to go untreated and be spread as a result of incorrect self-diagnosis, the likelihood of increased spread of herpes simplex virus and other sexually transmitted diseases, and how effective acyclovir would be for the indication sought.
Concerning its effectiveness, Bucci said, "Published clinical evidence does not support the routine use of orally administered acyclovir for the acute and suppressive management of recurrent genital herpes," the proposed indication.
"Herpes simplex virus requires considerable patient education, regarding the natural course of the disease, including potential for asymptomatic viral shedding and transmission, as well as psycho-social support," said Bucci.
Also opposing OTC status for acyclovir were the Centers for Disease Control and Prevention, the Infectious Diseases Society of America, the American Medical Association, the American Academy of Dermatology and ACT UP, representing gay activists.
Burroughs Wellcome maintained
that acyclovir is a suitable candidate for OTC status, arguing that OTC availability would encourage more people to seek treatment. In addition, with the help of an extensive education campaign the company plans, the public would be more aware of the presence of sexually transmitted diseases and be more wary of having unprotected sex, the company said.
Burroughs Wellcome said its studies show that genital herpes recurrences are reduced or minimized in more than 95% of patients taking acyclovir daily. The other treatment is taking the drug five times daily for five days when outbreaks occur. Of those suffering periodic bouts of herpes, about 400,000 take acyclovir daily to reduce the frequency and intensity of lesions. The cost is roughly $100 a month per patient.
Dr. Louise Tyrer, medical director of the Association of Reproductive Health Professionals, agreed there is a need for wider access to acyclovir. However, she said, widespread use could produce resistant strains of the virus. If FDA approves the OTC application, she said, the agency should insist studies be conducted to monitor drug-resistant strains and have a plan to deal with such an occurrence.
Several advocates of an acyclovir switch say parallels can be drawn between it and other drugs that have secured OTC status in recent years, such as clotrimazole for vaginal yeast infections and 1% hydrocortisone for skin disorders.
Cynthia Pearson, program director of the National Women's Health Network, who also testified in support of the switch, emphasized, "It is vital that over-the-counter acyclovir be labeled in the strongest terms possible stating that it is not to be used by persons who have not been diagnosed with genital herpes by a clinician."
Dr. Peyton Weary, president of the American Academy of Dermatology, countered that labeling and ad campaigns aren't valid substitutes for medical care. "The appropriate use of OTC acyclovir is predicated upon the assumption that the average citizen can readily diagnose herpes simplex infections."