Health
Are politics stalling OTC status for emergency contraceptives?
NEWS IN BRIEF — Posted May 3, 2004
Politics are interfering with the impending switch of emergency contraception to over-the-counter status, and this may damage the Food and Drug Administration's reputation, according to an editorial last month in the New England Journal of Medicine. It was authored by the journal's editor and two members of the Food and Drug Administration advisory committee that backed the switch in December 2003.
The committee recommendation elicited joy from those who support the switch but chagrin from those opposed. The agency was expected to announce its final decision in February but instead announced a 90-day delay. An FDA spokeswoman said the postponement of the decision was due to receipt of additional information about adolescent use that needed to be considered.
"The FDA's final decision will be supported by sound science and in full compliance with the applicable laws and regulations, while taking into consideration the recommendations of these advisory committees," said Christine S. Parker, public affairs specialist at the agency.
Advocates are also worried that the drug may also only be available over the counter with restrictions such as age limits or putting it in view of the pharmacist. These measures were rejected by the advisory panel.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2004/05/03/hlbf0503.htm.