Race-specific drugs: regulatory trends and public policy
By David E. Winickoff and Osagie K. Obasogie,
Trends in Pharmacological Sciences
| 06. 04. 2008
Numerous articles and commentaries in the health literature recently have questioned the emergence of race as an increasingly powerful organizing principle in clinical medicine and pharmaceutical development [1,2]. Yet proposals for regulatory reform remain thin. Debate over racebased medicine crystallized around the FDA's June 2005 approval of BiDil, a drug approved to treat African-Americans with heart failure. Some saw BiDil as a dangerous example of marketing trumping science [3], whereas others heralded BiDil as a step towards eliminating racial disparities in health care [4]. One thing is clear: the BiDil debate has left major questions about how clinical trial design and drug regulation should engage this trend [5].
The need for new regulatory approaches to medicines with race-specific indications is growing more acute. A new trend towards designing and conducting clinical trials for race-specific medicines [6] carries serious implications for equitable access to pharmaceutical innovations. Under current policies FDA-approved racial indications might prevent certain groups from accessing certain drugs, even when there is little evidence to warrant such exclusion. Given the stakes of such exclusions for public health, new regulatory...
Related Articles
By Michael Eisenstein , Nature | 05.09.2022
Two companies, Beam Therapeutics and Verve Therapeutics, are leading the charge of base editing therapies to the clinic. Last November, Beam got the green light from the US Food and Drug Administration (FDA) for its upcoming BEACON-101 trial that will...
By David Jensen, The California Stem Cell Report | 05.20.2022
Photo by Giorgio Trovato on Unsplash
The directors of the $12 billion California stem cell agency are looking for a new chair who is both decisive and collaborative, passionate and inclusive. But at the top of the wish list is...
By Staff, The Economist | 05.13.2022
Over the years, doctors have described more than 7,000 rare diseases, generally defined as those affecting fewer than one in 2,000 people. So, though individually unusual, such illnesses are collectively a serious problem—a long-tail of need which is hard to...
By Peter Ward, The Guardian | 05.05.2022
Photo by Jernej Furman on Flickr
Every year millions of people cross borders to undergo medical treatments that are either unavailable in their home country or too expensive. For many, this is a last resort to ease the pain of...