FDA Says it Has Authority to Grant OTC Status
During a House Energy and Commerce health subcommittee hearing yesterday, FDA officials "unequivocally asserted" that the agency has the authority to decide whether prescription drugs should be made available over the counter, even without the manufacturer's consent, CongressDaily reports. The hearing was held in response to the FDA's decision to consider a request by WellPoint Health Networks to make prescription allergy medicines such as Claritin and Allegra available over the counter. At the hearing, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, faced "strong questioning" by some committee members who expressed doubts about the safety of dispensing prescription drugs over the counter. Rep. Ed Bryant (R-Tenn.) asked, "If FDA has the authority over the objection of the manufacturer, who would do the safety testing?" Woodcock said that "much" is known about antihistamines because several are already available without a prescription. During the hearing, which was held to discuss how the government can save money on prescription drugs as it develops a Medicare prescription drug benefit, Woodcock also said that her agency needs additional funding to implement some statutes relating to the introduction of generic drugs. She said that the agency is also studying how increased prescription drug advertising has impacted consumers (Fulton, CongressDaily, 6/13).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.