The Food and Drug Administration (FDA) announced last week three proposals to study the quality and effectiveness of long-acting generic drug products, including levonorgestrel birth control products.
The FDA made the announcements on the National Institutes of Health’s (NIH) website for separate study proposals focused on long-acting pharmaceutical products: Pharmacometric Modeling and Simulation for Long-acting Injectable Products; Dissolution Methods for Long-acting Periodontal Drug Products; and Dissolution Methods for Long-acting Levonorgestrel Intrauterine System. The FDA’s focus is specifically on generic long-acting products, Regulatory Affairs Professionals Society (RAPS) reports.
The notice from the FDA’s Center for Drug Evaluation and Research (CDER) for the funding opportunity for the study of long-acting injectable products explains that the findings from the study will “help establish scientific and regulatory standards for ensuring therapeutic equivalence of generic long acting injectable (LAI) products. “The agency plans to spend as much as $600,000 on this area of research in 2016, RAPS reports.
The two other research awards relate to specific types of products: birth control implants and periodontal drugs. As the proposals explain, the FDA believes there is a “lack of compendial or biorelevant in vitro drug release assays for long-acting” periodontal dosage forms and intrauterine contraceptive systems. The FDA will spend at least $250,000 on developing those methods for periodontal drugs, and at least $125,000 on developing them for intrauterine drug systems, according to RAPS. The study on birth control devices will use the Mirena intrauterine device as a reference product, RAPS reports. The Mirena device works by releasing a daily dose of the hormone progestin levonorgestrel.
The FDA has noted a number of serious side effects associated with the Mirena including uterine perforation and migration of the device, pain, pelvic inflammatory disease (PID), and intrauterine and ectopic pregnancies. In some women, the device becomes embedded in the uterine wall. Numerous lawsuits have been filed by women who allege injuries from Mirena IUDs.