Regulatory Roundup: HHS Approves 100th PEPFAR Drug

October 15, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, USAID and USP launch counterfeiting public service campaign in Cambodia.

The US Department of Health and Human Services (HHS) marked the recent approval of the 100th antiretroviral drug in association with the President’s Emergency Plan for AIDS Relief (PEPFAR), aimed at the prevention, treatment, and care of people infected with and affected by HIV/AIDS worldwide, according to an FDA release. “This milestone exemplifies the dedication, caring, and hard work of all who strive to better the lives of those infected with or affected by HIV/AIDS,” said HHS Secretary Kathleen Sebelius in the release. FDA has reviewed more than 100 products as part of the PEPFAR program, 71 of which have been generic drug products.

The US Agency for International Development (USAID) and the US Pharmacopeial (USP) Convention, along with Cambodian authorities, launched a public service campaign in Cambodia and Southeast Asia on the subject of counterfeit medicines. Public service announcements designed to warn citizens of the dangers of counterfeit drugs are being broadcast throughout Cambodia. The organizations called counterfeits a “serious public health threat” in the region, given the spread of substandard drugs intended to treat HIV/AIDS, malaria, tuberculosis, and other life-threatening conditions, according to a press release.