Here’s an important global public health story that deserves wide attention (and, one might argue, words of praise from certain members of the United States Congress).
Major kudos are due to Mark McClellan (in his previous life as FDA Commissioner) and current FDA Deputy Commissioner Scott Gottlieb for navigating through the many obstacles to expedited FDA approval.
(I am proud to have played a very small role in helping make this a reality.)
Here’s the rest of the story …
The Food and Drug Administration has approved the first 3-in-1 antiretroviral pill for use by the American-sponsored plan for AIDS treatment. The pill, made by an Indian generic drug company, is for patients in countries helped by the President’s Emergency Plan for AIDS Relief.
Under that plan, the United States is now the largest provider of antiretroviral drugs in the world, paying for treatment for 561,000 patients in Africa, Asia and the Caribbean.
The Global Fund for AIDS, Malaria and Tuberculosis, the second-largest provider, pays for about 541,000 patients. (The United States also pays one-third of the Global Fund’s budget.)
The new pill, made by Aurobindo Pharma of Hyderabad, India, combines three common first-line drugs, AZT, 3TC and NVP, which are also known as zidovudine, lamivudine and nevirapine and sold in the United States as Retrovir, Epivir and Viramune.