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!!!!!!!!

.

 

Wyeth Announces it Will Eliminate 1,200 Jobs

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.

The company employees about 50,000 people worldwide with roughly half of them in the U.S.  Like some of its competitors, Wyeth is facing stiff generic competition for several products that are slated to lose patent protection over the next couple of years and recently has had trouble getting many of its new drugs approved by the US Food and Drug Administration.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!

When it Rains it Pours: The State of New Jersey Requests Amgen Documents for Off-Label Marketing of Enbrel

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.

In the subpoena served Monday, Attorney General Anne Milgram is seeking "a comprehensive array of documents and information" concerning the marketing and sale of Enbrel from July 2002 to the present.

The subpoena calls for Amgen to deliver the required materials by Feb. 4.

Although doctors are free to prescribe medicines as they see fit, drug companies are only allowed to promote their products for uses that have been approved by the U.S. Food and Drug Administration and appear on product labels.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!