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Friday, April 9, 2010

Food Drug Administration and Prescription Drug Manufacturer Partnership

The Prescription Drug User Fee Act (PDUFA) was passed into law by Congress in 1992 and allows the Food and Drug Administration (FDA) to collect feeds from Prescription drug Manufacturers to fund the new drug approval process.

The PDUFA declares that the FDA is allowed to collect a fee, called an application fee, from these Prescription Drug Manufacturers whenever a new drug is introduced through a new Drug Application (NDA). The fee was up to $250,000 per new NDA.

Note: Kinda looks like the FDA is now working for the Prescription Drug Companies. In fact, a comment from the Public Citizen’s Health Research Group stated “The review of new drugs is too important to leave to ‘user fees’ and likened the drug industry’s financial support of the FDA review process “similar to criminals paying user fees to the police department.”

Originally a short term experiment slated for 5 years, it was “improved” by The Food and Drug Administration Modernization Act of 1997 (FDAMA). This act extended user fees for NDA’s for another 5 years and introduced three amendments: Off Label Use of Drugs; Drug Labeling for Children: and, Fast Track or Accelerated Approval of new drugs.

Off Label Use pertains to using drugs for other than it was approved for. The FDA did away with thus prohibition on the Drug Companies promoting other than approved uses for their drugs, opening the door for Drug Salesman to promote new drugs with no proof of safety or effectiveness for the off label use.

The Drug Labeling for Children amendment. Previously drugs approved for adults were presumed to be safe in children albeit with different doses. This is not always the case. Now drug companies were required to do additional clinical trials to provide information for prescribing to children.

The Accelerated Approval and Parallel Tracking amendment opened up the door for new drug approval based on one “well controlled” Phase 3 clinical trail when the previous standard was two. There is no denying this amendment made drugs available that have saved countless lives, however with much less of a process to ensure safety.

The PDUFA III continued user fees and integrated a Medical Device User Fee as well. PDUFA IV was signed into law in September 2007 represents a significant addition to FDA authority. Among the many components of the law, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) have been reauthorized and expanded.

The FDA claims these programs will ensure that FDA staff will have the additional resources needed to conduct the complex and comprehensive reviews necessary to new drugs and devices. However, the FDA and Drug Manufacturers continued to share the same bed.

Allowing the industry to “negotiate” with the FDA on recommendations and “pay” the FDA user fees for new drugs undercuts the agency’s original true role as an independent, drug safety regulator. If the FDA and the prescription drug manufacturers are going to regain the respect and trust of the American public, the FDA must be seen as an objective regulatory entity with a clear and inviolable mission to serve the public, and its reliance on the fees and goodwill of the industry they are supposed to oversee must end.

The bottom line is that the prescription drug consumer needs to live by the old adage “let the buyer beware”. Do your own research and be careful for the drug interactions if you are taking multiple prescriptions, especially from multiple Doctors and Pharmacies.

In a perfect world, you would be able to mitigate much of the problems you are addressing by living a healthy lifestyle, eating low glycemic foods and taking the best nutritional supplements.

Stay Informed!


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