FDA is Taking Some Heat....Again
An article in today’s New York Times reports that several FDA scientists have accused the agency of granting market approval to several unsafe medical devices. According to published reports, “the House Committee on Energy and Commerce will investigate the accusations, first aired when eight agency scientists wrote a private letter in May to FDA commissioner Andrew von Eschenbach.”
Unfortunately, the allegations made by the eight scientists against the agency are nothing new. Frequently, agency managers (and sometimes political appointees) lean toward approving drugs or devices when the data pertaining to efficacy and safety are equivocal.
My sources at FDA suggest that this is what happened with approval of Merck’s ill-fated pain medication Vioxx.
Recently, there has been a spate of safety claims made against medical devices manufacturers. This is not surprising because the regulatory hurdles for marketing approval of devices are much lower for devices as compared with drugs and the medical devices and diagnostics business is the fastest growing sector in the life sciences. For an overview of the medical devices and diagnostics industry please read my recent article published in Science Careers.
Hopefully, new leadership at the agency will turn things around!!!!!!!
Until next time…
Good Luck and Good Job Hunting!!!!!!!!
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According to a post on the Wall Street Journal Health blog, Wyeth announced today that it is laying off about 1,200 marketing and sales representatives who helped support Protonix, its blockbuster heartburn and acid reflux medication. The job cuts are part of a previously announced “asset reallocation plan” that is designed to reduce the size of the company’s workforce by about 5% this year, and by 10% over the next three years. .gif)
Still reeling from lawsuits filed last week by ex-sales reps’ alleging improper marking of Enbrel to treat patients with psoriasis, Amgen was subpoenaed on Monday by New Jersey's attorney general regarding allegations that the company promoted Enbrel for unapproved uses.
