The list of approved and tentatively approved antiretrovirals in association with the US President's “Emergency Plan for AIDS Relief” presents a significantly interesting, yet not widely acknowledged fact.
Indian generic pharmaceuticals have quietly become part of the global HIV pharmacy for developing countries, particularly as the preferred pharmacist of the US President's Emergency Plan for AIDS Relief (PEPFAR).
Launched in 2003 by President George W. Bush, PEPFAR holds a place in history as the largest effort by any nation to combat a single disease. Thirty-three countries are directly benefiting from this global public health initiative.
In May 2004, in support of the President's Emergency Plan, US Food and Drug Administration (FDA) announced a new initiative to help ensure that those being served by the Presidents' Plan would receive safe, effective, and quality manufactured antiretroviral drugs.
Under this plan 116 compounds (fixed dose combination tablet or single tablet of antiretroviral medications) have so far been approved. Indian pharmaceutical companies supply nearly all of these - 112 compounds The other four are supplied, one by US, two by South Africa, and one by a Chinese pharmaceutical company.
The new FDA initiative included an expedited review process. Through an active outreach program to the pharmaceutical industry, FDA actively encouraged any sponsors worldwide to submit US marketing applications for single entity, fixed dose combination (FDC), and co-packaged versions of previously approved antiretroviral therapies - significantly, away from the protectionist trade behaviour of US government - even if there was still patent or exclusivity market protection for the product in the US.
FDA reviews the marketing applications using its normal standards for authorisation. If the product still has marketing protection in the US, FDA issues a "tentative approval" rather than a "full" approval.
The "tentative" approval signifies that the product meets all safety, efficacy, and manufacturing quality standards for marketing in the US, and, but for the legal market protection, it would be on the US market.
USAID allows, under the President's Emergency Plan, purchase of any product that has either a "full" or "tentative" FDA approval.
To the great advantage to the Indian generic pharmaceutical companies, under this initiative, FDA works intensively with manufacturers who have not interacted with them previously to help them prepare an FDA application and to prepare for the requisite inspections of their clinical trials and manufacturing facilities.
Due to the significant public health urgency of these products, FDA prioritises the review of these marketing submissions and has met its announced commitment to complete the reviews in as little as two to six weeks after submission of a high-quality application.
Under this new initiative FDA has also engaged proactively with its counterpart regulatory agencies in the President's Plan focus countries and with the WHO Pre-Qualification Unit.
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