Apr 20 2005
The emergency contraceptive drug Plan B will now be available over the counter in all of Canada as Health Canada yesterday ended the prescription requirement for Paladin Labs Inc.'s contraceptive.
Plan B, a drug that works best when taken within 24 hours of unprotected sex, is already sold without a prescription in British Columbia, Saskatchewan and Quebec.
Jirina Vlk, a spokeswoman in Ottawa for Health Canada, says no outstanding concerns on its safety in younger teens has been identified and they see no reason to delay timely access to other women.
In Canada, the U.K. and other countries, consumers can ask pharmacists to dispense medicines that do not require a doctor's prescription but which are considered not safe enough for sale without some consultation. The U.S.does not have a national system, but some U.S. states among them California, have developed programs to allow pharmacists to dispense Plan B.
Health Canada says that a number of European countries and several U.S. states have already granted access to emergency contraceptives via pharmacist- controlled sales. In Canada, behind-the-counter status would give timely access and professional advice.
The FDA in the U.S.is delaying its decision on Barr Pharmaceuticals Inc.'s application to end the U.S. prescription requirement for Plan B.
Last year the FDA rejected an application by Barr for over- the-counter Plan B sales, citing concerns about its use by girls 15 and younger. Canadian regulators said they considered the FDA position.
Democratic U.S. senators, supporting Barr's application, this month held up Lester Crawford's nomination as FDA commissioner.
Barr is seeking U.S. approval to sell Plan B without a doctor's prescription for women 16 and older. A prescription requirement would remain in place for younger women.
Paladin, based in Montreal, licensed Canadian rights to Plan B from closely held Women's Capital Corp. in 1999. Barr Pharmaceuticals Inc. acquired Women's Capital last year for about $21 million, gaining U.S. rights to the drug.