There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.
The President’s Emergency Plan for AIDS Relief (PEPFAR) is celebrating 20 years of providing vital therapies to poor nations in Africa and other regions to combat the spread of this lethal disease. The program was introduced by President George W. Bush and approved by Congress in 2003 to distribute antiretroviral drugs to third-world nations, where HIV/AIDS was threatening the survival of many populations. In recent weeks, policy makers and the public health community have applauded PEPFAR’s broad impact, highlighting its success in greatly reducing the spread of HIV—and in demonstrating the effectiveness of US international aid programs.
But despite long-standing bi-partisan support for the program, conservatives often have complained that PEPFAR funding to local health care agencies also supports family planning and abortion services. With Republicans controlling key House committees that authorize funding for international programs and foreign aid, right-to-life advocates are working to add anti-abortion provisions to legislation reauthorizing US international health programs, including PEPFAR. The chairman of a key House committee has threatened to block funding for the program unless it includes provisions to clarify that its funds cannot support abortion and related care.
Separately, the House Appropriations Committee added an anti-abortion provision to its recently approved FDA funding bill for fiscal year 2024. Republicans pushed through language that would limit telehealth prescribing for the abortion pill mifepristone, a policy adopted during the COVID-19 pandemic but now targeted by right-to-life proponents.
FDA plays an important role in PEPFAR by approving generic versions of patented and expensive AIDS treatments, but only for distribution outside the United States until domestic patents expire. This conditional approval process has enabled distribution of the most effective therapies to third-world countries without undermining markets at home and in other industrial nations. FDA has approved more than 200 antiretrovirals under PEPFAR and maintains a database to provide prescribing and use data.
In recognizing PEPFAR’s 20 years of success in greatly reducing the spread of HIV/AIDS, the Biden administration moved to map out next steps for the initiative. In the fall of 2022, it issued a report on Reimagining PEPFAR’s Strategic Direction, with the stated aim of ending the AIDS pandemic by 2030. The analysis calls for reducing new HIV infections, particularly in girls and young women, and strengthening the capacity of local governments and public health systems to lead and manage the program. Critics of PEPFAR have cited its language for supporting public health programs in Africa that advance family planning, despite adamant denial of those charges by State Department officials. The fear is that fearing the debate will delay the five-year reauthorization of PEPFAR under review by Congress.
Jill Wechsler is Washington reporter for BioPharm International.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.