FDA Allows Generic Form of PrEP to Be Marketed

PETAH TIKVA, Israel—The chemical formula "tenofovir disoproxil fumarate/emtricitabine" probably isn't familiar to most people, but those who deal with sexually transmitted infections (STIs) know that it's the basis for Gilead Pharmaceuticals' HIV blocker Truvada. Late last week, the Food & Drug Administration (FDA) approved Israel-based Teva Pharmaceuticals' application to market a generic form of Truvada—and it's got those at most risk for HIV infection cheering, and Gilead issuing cautions. "A generic version of Truvada will not be immediately available," Gilead said in a press statement. "It’s important to note that there are a number of factors involved in commercialization that are not tied directly to FDA approval." One of the things that might hold up the marketing is getting approval of the words Teva will use to describe its medication, with Tim Horn of the Treatment Action Group telling POZ.com that, "It’s not uncommon in patent settlement agreements for generics to negotiate language permitting full approvals months and years in advance of the settlement license date." It is not known at what stage those negotiations currently stand. Part of the reason for Teva's interest, in addition to the fact that roughly 30 million people currently live with the disease and it continues to spread among nealry all adult populations, is that the patent for tenofovir disoproxil fumarate expires next month, though its patent for emtricitabine has another four years to run, so Teva may have to license the emtricitabine in order to produce its generic Truvada unless the FDA approves its Abbreviated New Drug Application (ANDA), which Teva is using to challenge Gilead’s patent on its combination tablet and to get the right to produce its generic equivalent. While a generic Truvada is a good sign, according to Jeffrey S. Murray, MD, MPH, Deputy Director of the Division of Anti-Viral Products at the FDA, "Usually, it takes several generics before full cost-savings potential is reached though. Hopefully, this will help to expand PrEP availability for many." Of course, there's still the problem that a month's supply of PrEP even with insurance may cost as much as $500, and without insurance about $1,500, for some of which Gilead has established a fund for patients that helps defray the cost—but Republicans in both the House and Senate are working on "replacements" for the Affordable Care Act (aka Obamacare), one facet of which is the elimination of Medicaid expansion, which according to Queerty.com, could leave "access to PrEP, particularly for low-income Americans ... cut off in 31 states and the District of Columbia." "The new bill would begin phasing out federal money for the expansion in 2020, likely blocking new applicants and access to meds like PrEP," noted Kristen Bahler of Time magazine. "If the plan passes in its current form, traditional Medicaid will be replaced by per-capita grants, a fixed-sum per person, which could result in cuts over time. And a proposed repeal of the ACA’s cost-sharing assistance, which paid insurers to reduce the burden of enrollees based on their income, would make coverage more expensive for poor Americans." ACT UP and Treatment Action Group activist Peter Staley has expressed concern that with the advent of Teva's generic version, Gilead may alter or stop its patient assistance program, with Staley stating that he hopes Gilead will continue it, and that Teva will establish an assistance program of its own. The new bill would begin phasing out federal money for the expansion in 2020, likely blocking new applicants and access to meds like PrEP. If the plan passes in its current form, traditional Medicaid will be replaced by per-capita grants, a fixed-sum per person, which could result in cuts over time. And a proposed repeal of the ACA's cost-sharing assistance, which paid insurers to reduce the burden of enrollees based on their income, would make coverage more expensive for poor Americans