FDA Actions

FDA Actions

Plan B, the so-called "morning after pill" will soon be available to women age 17 and older without a prescription. Previously the FDA and the Bush administration had limited the access of the drug to women 18 and older but a U.S. district judge ruled in March that the older age limit was "arbitrary and capricious." The judge also directed the agency to evaluate clinical data to determine whether there should be any age restrictions on use of the drug. The FDA has no plans to appeal the court's decision. Duramed Pharmaceuticals must file paper work with the FDA, a process that is expected to take 30 days. Plan B is levonorgestrel in a 2-pill pack, the first to be taken within 72 hours of unprotected intercourse and the second pill 12 hours later.

The FDA has approved a new TNF-alpha blocker monoclonal antibody for the treatment of rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. Golimunab is given once a month as a subcutaneous injection in combination with methotrexate for rheumatoid arthritis. It may be used with or without methotrexate for psoriatic arthritis and as monotherapy for ankylosing spondylitis. As with all TNF-alpha blockers, the FDA is requiring a risk evaluation mitigation strategy (REMS), which includes a medication guide for patients and a communication plan for physicians regarding potential side effects. Also similar to other drugs in this class, golimumab will carry a boxed warning regarding the risk of tuberculosis and invasive fungal infections. Golimumab was developed by Centocor Ortho Biotech, a division of Johnson & Johnson. The drug will be marketed under the trade name Simponi™.