Scientific Laboratories, a contract firm operating in Columbia, Maryland, has been sanctioned by the FDA and has entered into a consent decree prohibiting it from engaging in commercial operations (manufacture and sales). Scientific Laboraties is run by Amit Roy and Rajeshwari Patel.
Scientific Laboraties has failed FDA inspections over the last several years and its products have failed to meet standards for good manufacturing practice requirements (CGMP).
The case looks remarkably similar to that of Able Laboratoires several years ago. There seems to be a growing trend of individuals moving from India and starting up small manufacturing facilities in the U.S. to produce generic drugs and OTC products.
While there are problems at manufacturing facilities oversees, there are also problems at firms here in the U.S.
Source: Pharmalot
Saturday, May 17, 2008
Wednesday, May 7, 2008
FDA Toughens Standards
While the Agency continues to maintain it is doing nothing differently, every drug maker in the country (innovator or generic) realizes this isn’t the case. The FDA approved only 18 novel products in 2007, the lowest number in at least a decade. And the backlog of generic applications is astounding.
The latest victims were last week’s double rejection of mipomersen from Isis Pharmaceuticals/Genzyme and Cordaptive from Merck. To an observer, it looks like a double homicide.
The FDA seems to be demanding new data on safety and efficacy that was not included in the initial trial design discussions. While this is new for manufacturers of primary care products like cholesterol medications, it is nothing new to researchers of cancer vaccines. For years, the FDA has changed standards on researchers mid-stream, including revisions on primary and secondary endpoints.
The main issue is whether any of this will actually make products safer…or more effective…for patients.
The latest victims were last week’s double rejection of mipomersen from Isis Pharmaceuticals/Genzyme and Cordaptive from Merck. To an observer, it looks like a double homicide.
The FDA seems to be demanding new data on safety and efficacy that was not included in the initial trial design discussions. While this is new for manufacturers of primary care products like cholesterol medications, it is nothing new to researchers of cancer vaccines. For years, the FDA has changed standards on researchers mid-stream, including revisions on primary and secondary endpoints.
The main issue is whether any of this will actually make products safer…or more effective…for patients.
Tuesday, May 6, 2008
The Other Shoe Falls at Merck
First, the FDA provided Merck with a non-approvable letter for Cordaptive. And now the other shoe has fallen – Merck will lay off approximately 20% of its sales force by the summer.
Merck had high hopes that the cholesterol drug Cordaptive could restore the luster to a rather tarnished portfolio. Vytorin has been maligned for safety concerns and unconventional (some say racist) DTC advertising campaign.
The additional 1,200 sales reps that will be loosing their jobs come on top of the 400 reps already eliminated.
Merck had high hopes that the cholesterol drug Cordaptive could restore the luster to a rather tarnished portfolio. Vytorin has been maligned for safety concerns and unconventional (some say racist) DTC advertising campaign.
The additional 1,200 sales reps that will be loosing their jobs come on top of the 400 reps already eliminated.
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