§ Lord Alton of Liverpoolasked Her Majesty's Government:
Whether they will review their decision to allow over-the-counter sales of the "morning-after" pill following the decision of the United States Food and Drug Administration to ban such sales. [HL3113]
65WA
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)Since 1 January 2001 pharmacists have been permitted to supply levonorgestrel 0.75mg to women aged 16 and over for use as an emergency contraceptive (the "morning-after" pill). There are no plans to review the decision which allows the supply of emergency contraception under these circumstances as there is no new evidence relevant to the criteria in the UK for Prescription Only Medicine status.
On 7 May 2004, the Food and Drug Administration (FDA) announced that it had issued a "not approvable" letter in relation to a proposal to make a product for emergency contraception available without prescription in the United States (US). The letter also outlined the additional information that would be required to gain approval to market the product. In particular, the FDA was concerned about the lack of data concerning the use of the product among adolescents younger than 16 years old. In the US, unlike pharmacy availability in the UK, supply without a prescription is comparable to supply without the supervision either of a doctor or a pharmacist.
The Medicines and Healthcare Products Regulatory Agency (MHRA) keeps the safety of all medicines under review. The MHRA will continue to monitor the safety of levonorgestrel 0.75mg and will review any potential safety issues in the light of any new evidence which may emerge.