May 2009 Drug News
U.S. Declares Swine Flu Emergency
U.S. officials declared a public health emergency and outlined the administration’s response to the swine flu outbreak, which has caused as many as 81 deaths in Mexico. Twenty milder cases have been reported in the U.S., and more are expected. Reuters Meanwhile, officials released 12.5 million doses of antiflu drugs from the national stockpile, and drug makers stated they could supply millions more doses of medicine and were ready to work on a vaccine against the new swine flu strain. ABC News, Reuters
CDC: Practical Precautions Can Help Avoid Swine Flu
Richard Besser, acting head of the Centers for Disease Control, stated that the U.S. government is being “extremely aggressive” in the steps it has taken, or is considering, to protect the American public. In the meantime, the best response is to do “the things we learned when we were little,” like covering one’s mouth when coughing, frequently washing hands and staying home with a fever. The Associated Press
FDA to allow ‘morning-after’ pill for 17-year-olds
WASHINGTON – Women’s groups cheered the government’s decision to allow 17-year-olds to buy the “morning-after” emergency contraceptive without a doctor’s prescription, but conservatives denounced it as a blow to parental supervision of teens. The Food and Drug Administration said Wednesday it would accept, not appeal, a federal judge’s order that lifts Bush administration restrictions limiting over-the-counter sales of “Plan B” to women 18 and older. U.S. District Judge Edward Korman ruled last month in a lawsuit filed in New York that President George W. Bush’s appointees let politics, not science, drive their decision to restrict over-the-counter access. Women’s groups said the FDA’s action was long overdue, since the agency’s own medical reviewers had initially recommended that the contraceptive be made available without any age restrictions. Korman ordered the FDA to let 17-year-olds get the birth control pills. He also directed the agency to evaluate clinical data to determine whether all age restrictions should be lifted. The FDA’s latest action does not mean that Plan B will be immediately available to 17-year-olds. The manufacturer must first submit a request. Source: Associated Press/AP Online
AARP: Brand name drug prices rose 8.7% in 2008
AARP’s annual study on drug prices found the cost of popular brand-name prescription medications rose by 8.7% in 2008. The study also showed generic drug prices continued to fall and that more seniors switched from brand medications to generic alternatives. Yahoo!/The Associated Press (4/15)
FDA Reverses Unapproved Liquid Morphine Decision
On April 9, FDA reversed its decision to pull unapproved liquid morphine off of the market, allowing manufacturers of the unapproved products to continue marketing and distributing them for a limited time. FDA notified manufacturers and distributors of morphine sulfate elixir 20 mg/mL that it would give them a 180-day stay of enforcement after similar therapies are approved or alternative medications become widely available. FDA’s decision to reverse its ruling was made after hearing from patients, hospice and pain care advocates that there is no good substitute. Warning letters remain in effect for other manufacturers of unapproved narcotics.
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