It is hard to believe that it is already Memorial Day Weekend. The year is slipping by so fast. Now we sit on the cusp of summer – the honeysuckle is blooming in my yard and the scent will wash over my back yard traditional Memorial Day lobster fest. But, of course, first you must hear about what happened this week:
- The Case of the Mistaken Monkfish – The FDA issued a warning about the mis-labeling of fish as monkfish, when if fact, it might be puffer fish, "containing a potentially deadly toxin called tetrodotoxin. Eating puffer fish that contain this potent toxin can result in serious illness or death." Ouch. As with many problematic food products of late, this one was imported from China.
- New Contraceptive Approved for Continuous Use – The FDA approved a new contraceptive that can eliminate menstruation in women taking it called Lybrel. According to the release, "[w]omen who use Lybrel would not have a scheduled menstrual period, but will most likely have unplanned, breakthrough, unscheduled bleeding or spotting. " Other contraceptives have periods of time when the cycle would occur. At the same time, interestingly, according to the company’s release, "[b]ecause regular monthly bleeding does not occur on Lybrel, an unexpected pregnancy may be difficult to recognize." The product is manufactured by Wyeth.
- Testimony by FDA on "Programs Affecting Safety and Innovation in Pediatric Therapies" – On Tuesday, May 22, Rear Admiral Sandra Lynn Kweder, M.D., Deputy Director, Office of New Drugs at CDER testified before the Subcommittee on Health, Committee on Energy and Commerce in the House on safety and innovation in pediatric therapies. She focused comment on two pieces of legislation Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) citing them as success stories. "{T]here is no question that they have expanded access to important therapeutics for children, and promoted safety and innovation in drug development. "
Have a safe and restful weekend everyone.
