Case: 23-10362 Document: 543-1 Page: 5 Date Filed: 08/16/2023
necessary to ensure the drug is used safely. Id. § 314.520(a). Relevant here, the agency may mandate that the drug be administered at “certain facilities or [by] physicians with special training or experience,” or that “specified medical procedures” be used. Id. § 314.520(a)(1), (a)(2).
FDA has explained that it will consider accelerated approval in two situations: where the agency can reliably estimate effectiveness using a “surrogate endpoint”; and where FDA “determines that a drug, effective to the treatment of a disease, can be used safely only if distribution or use is modified or restricted.” 57 Fed. Reg. 58942, 58942 (Dec. 11, 1992). The agency has understood approval under Subpart H as also satisfying the general approval conditions provided by the Food, Drug, and Cosmetic Act. See id. (“Drugs or biological products approved under these procedures will have met the requisite standards for safety and effectiveness under the [Act] … and, thus, will have full approval for marketing.”).
In March of 1996, an entity known as the Population Council applied for FDA to approve mifepristone as a new drug, as part of a two-drug regimen designed to cause abortion.[1] The regimen works like this: First, a pregnant woman takes mifepristone, which suppresses the production of the hormone progesterone. Progesterone is needed for the pregnancy to continue; it prepares and maintains the uterine lining and stimulates the production of nutrients. After taking mifepristone, a patient takes misoprostol, which causes the uterus to cramp and expel its contents.
As part of the new drug application, the Population Council relied on three clinical studies, one conducted in the United States and two conducted
- ↑ The Population Council is a non-profit organization. Roussel Uclaf—the French pharmaceutical company that originally developed mifepristone—donated the American patent rights to the Population Council in 1994. The Population Council then granted Danco an exclusive license to manufacture and distribute Mifeprex in the United States.
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