A number of barriers to pre-exposure prophylaxis (PrEP) uptake, use, and adherence have been identified—cost shouldn’t be one of them By James Krellenstein and Jeremiah Johnson On July 16, 2012, the U.S. Food and Drug Administration (FDA) approved Gilead Sciences’…
The story of U.S. drug pricing run amok isn’t just about corporate arrogance and avarice—it is also about government permissiveness and inaction By Tim Horn, Erica Lessem, and Kenyon Farrow On December 1, 2015, the U.S. Senate Finance Committee issued…
By Tim Horn The way I see it, you can go down in history as the poster boy for greedy drug-company executives, or you can change the system—yeah, you. —U.S. Representative Elijah E. Cummings (D-MD) With these words, directed at…
By Tim Horn In response to growing public concern with health risks posed by approved drugs, a 2006 landmark report by the Institute of Medicine (IOM) argued that the U.S. Food and Drug Administration (FDA) lacks the unambiguous authority necessary…
Federal legislation promises a substantial increase in NIH funding—at the expense of a significantly weakened FDA By Kenyon Farrow For more than a year, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) of the House Energy and Commerce Committee hosted…
Can regulatory incentives promote responsible TB drug development? By Lindsay McKenna and Erica Lessem There are woefully few drugs in development with the potential to improve the safety and effectiveness of tuberculosis (TB) treatment. Indeed, the market-driven approach to drug…
Supportive regulatory guidance for cure research requires a clear understanding of all possible outcomes, including remission By Richard Jefferys The term remission is increasingly being invoked in the context of cure research and, by extension, is an issue for regulatory…
Worldwide inefficiencies in drug approval processes are proving disastrous for people living with TB and other diseases By Erica Lessem Access to safe and effective tuberculosis (TB) medicines depends greatly on efficient and stringent regulatory review, without which improved health…
Regulatory filing and review delays keep Truvada as pre-exposure prophylaxis out of reach of those who need it most By Scott Morgan Pre-exposure prophylaxis (PrEP) is the use of antiretroviral medication to prevent HIV acquisition. The U.S. Food and Drug…
