Pharma comes together over Africa - and challenges cheaper generics

For more and more Africans, HIV treatment may soon be as easy as popping two pills a day—but stateside HIVers may be late to the party. As the first $350 million of President Bush’s $15 billion Emergency Plan for AIDS Relief (PEPFAR) reached African HIVers, U.S. global AIDS czar Randall Tobias announced May 16 that the Food and Drug Administration (FDA) would begin reviewing first-line, three-in-one capsules—previously available only as India-made generics—to encourage drug companies to make simpler meds for HIV-ravaged countries. Compared to domestic $15K first-line regimens, India’s all-in-one combos are cheap ($140 a year) and simple (two pills daily). The meds treat thousands of PWAs worldwide, but the U.S. had refused to buy them for PEPFAR since their brand-name counterparts are still under patent here.

The day after Tobias’ announcement, however, big pharma got with the program. Gilead, Merck and Bristol-Myers Squibb announced the first-ever multi-company partnership to make triple combos of patented meds—a feat activists have pursued for years—for overseas use only. Tom Flavin, PEPFAR’s public-affairs officer, told POZ, “We’ll buy the best drugs available at the cheapest price,” though the best has yet to be determined.

Tobias said the FDA will test the three-in-one generics, along with newer brand-name combos, despite the preexisting World Health Organization (WHO) review process. Critics say the second approval requirement needlessly impedes generics—though at press time, the WHO had temporarily withdrawn approval of two India-made HIV generics after routine lab inspections uncovered faulty paperwork records. The FDA’s Debra Birnkrant, MD, says, “The WHO’s approach is laudable. But [the U.S.’s] FDA should take the lead.”

Will PEPFAR’s combo mambo finally propel all-in-one pills, generic or otherwise, onto U.S. shelves? Health Global Access Project’s Jennifer Cohn, a treatment advocate and MD, believes that for now, the feds will push for neither—to protect pharma’s domestic market. “The feds fear an awareness that quality, cheap generics are out there,” she says, “and that Americans who can’t get them [and must pay more for name brands] are going to be pissed.” Meanwhile, here’s to Africa.