FDA to begin fast-tracking even more dangerous Big Pharma drugs

Thursday, September 05, 2013 by: Ethan A. Huff, staff writer
Tags: FDA approved drugs, fast track, clinical trials

(NaturalNews) The U.S. Food and Drug Administration (FDA) wants to expand the list of drug types eligible for its so-called "Fast Track, Accelerated Approval and Priority Review" process, which is really just a fraudulent shortcut method for drug companies to rush potentially-deadly new drugs to market without appropriate regulatory review. According to reports, the FDA plans to allow certain obesity treatments, antibiotics, and other drugs to be peddled to the masses without first undergoing the normal drug review process, a scheme the agency claims is in the best interests of public health.

The changes, which FDA Commissioner Margaret Hamburg recently proposed to a group of scientific advisers, would fast-track certain untested drugs to market via condensed clinical trials, would have smaller sample sizes and entail shorter duration periods. These same fast-tracked drugs would also receive a special type of priority approval status, allowing them to be prescribed by doctors to so-called "critical need" patients willing to bear the drugs' unknown side effects.

"Under the new pathway, the FDA would allow developers of such drugs to conduct smaller, faster clinical trials, and provide a 'special medical use' label which would allow doctors to administer drugs to patients with critical need," says MedCity News about the proposed new FDA protocols. "(Commissioner) Hamburg has said that the FDA needs to take into account the needs people with deadly or debilitating diseases that may be willing to take on the risks of unproven drugs."

So while the FDA strongly opposes the use of natural supplements to treat conditions like obesity and chronic infections because they have never undergone the official FDA approval process and are thus "unproven," the agency wants to give untested, unproven drugs an arbitrary stamp of approval, even though these synthetic substances could end up killing patients. Such blatant hypocrisy illustrates how utterly corrupt the FDA has become with its patently obvious bias towards pharmaceutical drugs.

The FDA has already been fast-tracking untested and unproven cancer drugs to market with the unenforced stipulation that drug companies perform post-market approval studies to verify safety and effectiveness. But in most cases, the companies responsible for such drugs never perform any follow-up studies, and the FDA imposes no penalties or restrictions on them for violating the law. Many new drugs, in other words, are being administered to patients without ever having been at all evaluated for safety or effectiveness.

Sources for this article include:

http://medcitynews.com

http://regulatoryaffairs.pharmaceutical

http://hsionline.com/2011/03/01/empty-promise/