FDA partners with WHO to expedite review of HIV drug applications

BY Sandra Levy

The Food and Drug Administration is working with the World Health Organization to pilot a process to share documents on HIV drug applications that have been approved or tentatively approved by the agency under the U.S. President’s Emergency Plan for AIDS Relief, or PEPFAR.

In this initial pilot, to be called the Collaborative Registration Procedure-Lite, or CRP-Lite, the FDA will, with the applicants’ permission, provide the WHO/PQP with minimally-redacted reviews of one or two HIV drug applications. The WHO/PQP will then use the FDA’s reviews to expedite its own regulatory decision making, producing review dossiers which can in turn be shared with regulators in resource limited countries to speed up their own regulatory review processes—making lifesaving drugs available to patients who need them the most.

“Since PEPFAR)was launched 15 years ago to battle the global HIV/AIDS epidemic, more than 17 million lives have been saved and currently over 14 million people living with HIV in the countries served by the program are being provided with safe, effective and low-cost antiretroviral therapy, including over 700,000 children,” FDA’s deputy commissioner for policy, planning, legislation and analysis Anna Abram said.

Abram continued,“As we mark this year’s World AIDS Day on December 1, we reflect on the progress we have made in the global fight against HIV/AIDS as well as the men, women and children living with HIV who do not have access to prevention, care and treatment. As part of our public health mission, the FDA has played an important role in supporting PEPFAR and the agency remains committed to doing what we can to facilitate timely access to these essential medicines.”

PEPFAR was launched in 2003 to address the global HIV/AIDS crisis by using U.S. funds to purchase, at low cost, antiretroviral therapies, including new combinations and formulations of medicines, for treatment in countries with limited resources that were hard-hit by the epidemic.


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