Saturday, December 12, 2015

21st Century Cures Act

This is a looming problem as the pharmaceutical industry lobbies its way through Congress. The Act would enable the pharma industry to postpone longer availability of generics, allow fewer safeguards for new drug development which will supposedly enable faster cures. But would do nothing to stop even higher prices on new drugs.

" Rather than simply charging less, the industry is pushing for watered-down safeguards it claims will lower development costs and get patented drugs to market sooner and cheaper. It will deploy 1,200 lobbyists to try to pass the 21st Century Cures Act. This bill has already passed the U.S. House of Representatives and will have its companion bill introduced in the Senate."

"This initiative is being sold as enabling new cures to treat rare and difficult-to-treat diseases by increasing funding for biomedical research at the National Institutes of Health. But, at the same time, the pharmaceutical industry will be able to use this bill to undermine FDA safety requirements by making it easier to get their drugs approved more quickly. The industry blames rising drug development costs on the FDA's drug approval process, which it says is too lengthy."

The FDA is not there to slow approvals but to keep American's safe. Using Vioxx as an example, this drug was approved and then found to cause thousands of heart attacks and deaths. 

"Investing in scientific research is, of course, a no-brainer. But the Cures Act will not only do that. Under the bill, research funding would be increased at the expense of lowering patient protections and reducing access for affordable medicines.

A key responsibility of the FDA is oversight to ensure that the risks of new drugs and medical devices don't outweigh the benefits.

Well-designed Phase III clinical trials conducted by pharmaceutical companies to get their drugs approved by the FDA are critical for weeding out unsafe and ineffective drugs. More than a third of the drugs that enter Phase III testing fail to gain FDA approval for this reason.

One of the main advocates behind the 21st Century Cures Act, The Manhattan Institute, cites drug development costs of Phase III clinical trials as a barrier to medical innovation and rising costs."

But the problem isn't with the FDA approval process. Its that 1/3 of the drugs going through Phase III trials fail because the drugs don't work. Where is the patient safety if the drug doesn't work or has too any side effects?

"...the pharmaceutical industry will make exaggerated claims and call for reforms gutting safeguards in the name of reducing drug prices. It will contest how its products save lives, extolling the virtues of their government-backed monopoly pricing power that in reality exploits our poor and sick. The 21st Century Cures Act will be included in this campaign."

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