The US Food and Drug Administration's (FDA) Blood Products Advisory Committee voted 17-0 on 15 May to recommend OraSure's In-Home OraQuick HIV Test, the first such product to be approved for over-the-counter (OTC) testing for the Human Immunodeficiency Virus (HIV). According to clinical studies, the device is 99.98% effective at determining whether or not a person is infected with the HIV virus. The product had been faced with some early concerns about the accuracy of t...

A Senate hearing being held by Senator Bernie Sanders (I-VT) seeks to advance legislation that would create a prize fund for companies to create new medicines and vaccines, partially replacing the current market-exclusivity model of product development. Sanders' legislation, S.1137: The Medical Innovation Prize Fund Act , was introduced in May 2011, but has thus far eluded much notice. In remarks on the Senate floor on 15 May, Sanders said he did not expect the bill...

The AIDS Healthcare Foundation (AHF) has launched an aggressive public advocacy campaign calling for the resignation of the US Food and Drug Administration's top regulator, Commissioner Margaret Hamburg in response to FDA's approval of the anti-HIV prophylaxis drug Tuvada. In a statement released to the media on 27 March, AHF called on Hamburg to step down "in response to the agency's gross mismanagement of new product reviews and a lack of transparency" at FDA. "Hambu...

The European Medicines Agency (EMA) released new reflection paper 15 March on the development of pre-exposure prophylaxis (PrEP) products for Human Immunodeficiency Virus (HIV). The paper, intended for pharmaceutical companies, aims to assist in the development of oral and topical medications to be used as part of an integrated risk-reduction approach. "This reflection paper sets out a consolidated position based on this research, which has culminated in the positive re...