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FDA abandons science with new 'breakthrough therapy' designation for drugs that receive almost no testing

Monday, August 05, 2013 by: Ethan A. Huff, staff writer
Tags: FDA, breakthrough therapy, drug testing

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(NaturalNews) For years, the pharmaceutical industry has been searching for new ways to get its drugs to market faster and with fewer pre-approval testing and clinical trial requirements. And it appears that the industry has made significant headway with the 2012 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA), which allows some untested drugs to be rushed to market very quickly under the designation of being a "breakthrough therapy."

According to a recent Reuters report, some 67 drug requests have been submitted to the U.S. Food and Drug Administration (FDA) for breakthrough therapy designation since the new law was passed last July. The FDA has, so far, approved 24 of them and denied 18 others. But drug companies are ecstatic about the possibility that new drugs coming down the development pipeline have the potential to be rushed to market in a matter of months rather than years.

"Everything is on the table," Johnson & Johnson (J&J) Head of Global Regulatory Affairs Dr. Jay Siegel is quoted as saying to Reuters about the process. J&J, which has been implicated in dozens of drug and consumer product recalls in recent years, is currently pressing the FDA to designate its new ibrutinib drug for cancer as a breakthrough therapy in order to rush it as quickly as possible to market.

"Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions," explains the FDA on its website. "The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy."

The key word here, of course, is "may," which allows drug companies a substantial amount of wiggle room when it comes to proving that a new drug offers any legitimate benefits beyond what existing drugs offer. Unlike with the traditional drug approval process, breakthrough therapy drugs are not required to undergo any rigorous clinical trial process to verify either their safety or effectiveness.

Once on the market, breakthrough therapies do not necessarily have to be tested any further

Also problematic is the fact that FDASIA does not outline how breakthrough therapy drugs are to be handled after they are rushed to market. One would assume that drug companies would be required to continue testing breakthrough therapy drugs after they receive this designation as an appropriate follow-up. But as it stands, breakthrough therapy drugs are simply dumped onto the market and forgotten about by regulators.

"A discussion on this topic is reckless if it doesn't discuss the next stage after the drug reaches the market," says Sidney Wolfe, co-founder and senior adviser of the consumer watchdog organization Public Citizen's Health Research Group (PCHRG). PCHRG has long tried to get the FDA to take a more responsible approach to the approval, withdrawal, and general monitoring of approved drugs.

As far as J&J and the others are concerned, however, FDASIA is perfect as is, because it allows them the opportunity to dump a slew of new drugs on the market much more quickly, and thus expand their profit potential. Speaking on behalf of J&J, Dr. Siegel told the media that he hopes this same lax approval standard will be adopted all across the globe.

"Our hope is that foreign regulators will catch up," stated Dr. Siegel, inferring that anything-goes drug approval guidelines are somehow progressive.

Sources for this article include:

http://www.reuters.com

http://www.fda.gov

http://www.foxnews.com
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