FDA uses stalling tactics to delay approval of over-the-counter emergency contraception in US.

The fight in the US to gain approval for over-the-counter status for emergency contraceptives (EC) has been long and drawn out. Over four years ago, the Centre for Reproductive Rights filed a citizen's petition on behalf of many health care and reproductive rights organisations for the acceptance of EC products for over-the-counter status, but the FDA failed to act. Last year, the FDA denied a request from the manufacturers of one product called Plan B to make it available over-the-counter, citing a lack of information on whether EC could be taken safely by women under the age of 16 or whether easier access would promote risk-taking sexual behaviour among teens, despite considerable scientific evidence to the contrary. An internal memorandum at that time suggests that the FDA failed to follow proper procedure in making that decision. In the April 2004 memo, the Director of the FDNs Office of New Drugs, Dr John Jenkins, wrote that "[the FDA] bas not heretofore distinguished the safety and efficacy of Plan B and other forms of hormonal contraception among different ages of women of childbearing potential and I am not aware of any compelling scientific reason for such a distinction in this case." He further wrote that "the available data clearly support a conclusion that Plan B meets the statutory and regulatory requirements for availability without a prescription for all age groups. Such a conclusion is consistent with how the Agency has made determinations for other over-the-counter products, including other forms of contraception available without a prescription."

The makers of Plan B submitted a modified application seeking over-the-counter access for their product for women over the age of 16, but the FDA recently announced that it is delaying a decision on that application too. In response, the Centre for Reproductive Rights filed a suit alleging that the FDA has violated the Administrative Procedures Act and US Constitution by denying women access to Plan B without a prescription, and by failing to follow its own procedures and statutory and regulatory mandates. The outcome is awaited. (1)

(1.) Press Release. Centre sues FDA for denying women over-the-counter access to emergency contraception: FDA internal memo suggests agency did not follow regulations. 21 January 2005. At: <www. reproductiverights.org/pr_05_0121 planb.html>.