Hours after Dr. Scott Gottlieb, administrator of the Food and Drug Administration, announced a ban on certain drugs covered by a trade agreement between Africa, Latin America and the Caribbean (ALPCA), just days before President Jacob Zuma is expected to visit the U.S., U.S. Vice President Joe Biden is traveling to South Africa.
“[The] administration is directing the government of South Africa to immediately implement the provisions of the Public Health Emergency Preparedness and Response Act, including the ban on the export of medical-grade blood products and certain chemical and biologics to South Africa,” Gottlieb wrote on the FDA’s website, as reported by The New York Times.
According to the FDA, while most of the aforementioned drugs were already being rejected by South African health care providers, the ban would now effectively extend the controversial measure to all pharmaceutical companies. The order came as a surprise to drug companies and medical research organizations in the U.S. — and despite long-term denials by Zuma that South Africa required blood, despite having in fact banned the shipment of all pharmaceuticals earlier this year.
In a statement Monday, Dr. Ryan Warren, associate director for biosafety and export at the FDA, said the ban was in the interest of safety for the people of South Africa. “Our concern is with the ability of South African nationals to safely receive, maintain, and subsequently donate blood under the control of clinical professionals,” Warren wrote. He added that while South Africa was not a hotbed of infectious disease, it could take years to screen for drug resistance.
Just hours before Dr. Gottlieb issued the ban, a medical ethicist told Vice News that the U.S. administration did not have enough information to implement the order. “It’s possible but it might take some time. It might be designed to see what South Africa can do to meet the requirements,” he said.