Pharmalot… Pharmalittle… Your Roundup
1 CommentBy Ed Silverman // July 13th, 2007 // 7:21 pm
As the week draws to a close, we want to thank you for your patience and support, given the sporadic posting. The past week was filled with interesting adventures, although these interfered with the usual routine. Nonetheless, the full menu of news and chatty items will resume in full throttle shortly. Meanwhile, we hope your evening is pleasant and we look forward to your continued visits….
The FDA has issued waivers on conflicts of interest to six members of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which will hold a joint meeting on July 30 to review Avandia. Of those, one was issued to Cleveland Clinic’s Steve Nissen. Some of the info is redacted. Sen. Chuck Grassley welcomed the release of the info, but expressed caution if the meeting is organized by the FDA’s Office of New Drugs.
Jazz Pharmaceuticals has agreed to pay $20 million to settle charges leveled by federal authoritiesthat its Orphan Medical unit promoted the Xyrem narcolepsy drug for unapproved uses, such as fatigue, insomnia, chronic pain, depression and other disorders. The $20 million in civil and criminal penalties must be paid over a five-year period. The criminal misbranding scheme induced physicians to write prescriptions for Xyrem that were not reimbursable by private health insurers or public insurance programs like Medicare and Medicaid, causing millions of dollars in losses for insurers, according to a Justice Department statement.
In other news, Plan B sales have doubled since the FDA authorized the switch for women 18 and older last August, rising from about $40 million a year to what will probably be close to $80 million for 2007, according to Barr Pharmaceuticals, which makes Plan B.
“This is exactly what we hoped would happen,” Susan Wood of the George Washington University School of Public Health, tells The Washington Post. As assistant commissioner for women’s health and director of the FDAS’s Office of Women’s Health, Wood pushed for the switch. “What we’re seeing is women who needed this product now finally having access to it.”
But conservative groups that fought the switch are upset. “This is very concerning,” says Charmaine Yoest of the Family Research Council, which is among several groups suing the FDA to reverse the decision. “We think this is putting women’s health at risk.”
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How can you be sure the Washington Post article reported the sales figures accurately since it misreported pretty much everything else–from what Plan B is, to its ingredients, to what the FDA said about its OTC sale?