PHARMACY

Two key Michigan Congressmen question FDA’s plan to outsource more than 300 jobs

BY Adam Kraemer

WASHINGTON Two House Democrats, Reps. John Dingell and Bart Stupack, both Michigan Democrats, are investigating the Food and Drug Administration’s plan to consider outsourcing more than 300 jobs.

Dingell and Stupak sent a letter Friday to the FDA, requesting all documents connected with the agency’s plan to consider contracting 322 jobs to private companies.

In a statement, the congressmen called the plan “hasty and injudicious” and said the FDA should wait for the recommendations of the Import Safety Working Group formed last month by the White House.

“It is truly incomprehensible why the agency would again consider reducing the expertise and institutional knowledge of the FDA at a time when FDA’s credibility with the American people is at an all-time low,” said the statement from Dingel, chairman of the House Committee on Energy, and Stupak, who chairs its subcommittee on Oversight and Investigations.

FDA spokesman Christopher Kelly said the agency will remain “committed to our dedicated work force and continue to improve operational efficiency directed at protecting the health and safety of the American public.” He said that the FDA is reviewing the letter and plans on responding shortly.

The FDA has reported that their list of outsourced jobs includes only administrative jobs that aren’t directly involved in safety inspections.

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Teva receives final FDA approval for generic Famvir, but will delay marketing until patent hearing

BY Drew Buono

JERUSALEM Teva Pharmaceuticals has been granted final approval on its application to market famciclovir, the generic version of Novartis’ Famvir in the 125, 250 and 500mgs.

Now with the approval from the Food and Drug Administration, Teva is also awarded a 180-day period of market exclusivity. But the company will hold off marketing the item until at least Sept. 5, 2007.

On that day, a hearing will be held involving a patent infringement suit brought against Teva regarding the famciclovir. The hearing is scheduled to meet at the U.S. District Court for the District of New Jersey regarding Novartis’ motion for a preliminary injunction. Therefore, both parties have agreed to not launch a generic version of Famvir until after the hearing.

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Forest, Daiichi Sankyo sign agreement for Azor

BY Drew Buono

NEW YORK Forest Laboratories and Daiichi Sankyo have signed a co-promotional agreement for Daiichi Sankyo’s new antihypertension drug Azor. Azor is a combination of the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil.

Under the agreement, Forest will pay Daiichi Sankyo an upfront payment of $20 million and will receive a payment based upon product sales. The agreement is for three years, after which, Daiichi Sankyo will make residual payments to Forest.

The drug is still under review by the Food and Drug Administration with a decision expected by late September. Hypertension affects roughly 72 million people in the U.S., with about 65 percent of those diagnosed having trouble keeping it under control.

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