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U.S. Congress debates bill to let Big Pharma get more dangerous, ineffective drugs approved


21st Century Cures Act

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(NaturalNews) A piece of legislation that will endanger American consumers by giving Big Pharma a more streamlined, quicker drug approval process that will no doubt lead to dangerous medications being marketed and sold before adequate testing has just passed a major milestone.

In recent days, the House Energy Commerce Committee approved by a unanimous 51-0 vote the 21st Century Cures Act, legislation that, the committee said in a press release, "accelerates the discovery, development, and delivery of life saving and life improving therapies and transforms the quest for faster cures."

In particular, the law would among other things:

-- remove barriers to increased research collaboration;

-- modernize clinical trials;

-- remove regulatory uncertainty for the development of new medical apps; and

-- provide new incentives for the development of drugs for rare diseases.

Click here to search GoodGopher.com for Big Pharma.

Current hard-won approval process just fine

"This nonpartisan legislation is a product of more than a year of working with patients, advocates, researchers, innovators, and health care professionals to bring our nation's laws up to speed with advances in medicine and technology," the press release said.

But a pair of activists and a former commissioner of the Food and Drug Administration – the federal entity that approves new medications for the consumer market – are skeptical. In an editorial in The New York Times, activists Gregg Gonsalves and Mark Harrington, former members of Act Up/New York, and former FDA Commissioner David Kessler, are urging Congress to keep the current FDA approval process as is.

The writers base their argument in the AIDS epidemic of the 1980s, in which several lawmakers and policymakers urged quicker FDA approval of drugs aimed at fighting HIV, even if they had not yet been properly tested and vetted.

"The danger of faster drug approval was that a devil's bargain would be struck: quicker access to experimental drugs, but without first determining whether these drugs were safe and would improve health and extend life," they wrote.

During the AIDS epidemic groups like Act Up (AIDS Coalition to Unleash Power) were frustrated by the FDA because they believed that the FDA's drug approval process was too slow and overly bureaucratic. The agency "seemed indifferent to the sufferings of thousands, including some of the most vulnerable in our society: gay men, minorities, drug users and infants," they wrote.

However, prompted by organizations like Act Up and others, the FDA began to work more closely with groups to speed drugs to market. "Novel processes were devised that expedited approvals of these new drugs by allowing their conditional release, pending further studies by the companies that developed them," the trio wrote.

Bill 'opens the door' to liabilities

And even though the experimental medications were reaching patients faster, "these new [FDA] procedures maintained the essential responsibility that drug companies have to patients and the American public: They would still have to show that the new drugs were safe and effective under the usual criteria required by the agency," they said.

In the end, the FDA actually became the fastest agency of its kind in the world, approving new medications much more quickly than European or Asian counterparts. Today, "the agency has introduced new mechanisms such as fast-track and breakthrough drug designations that are increasingly being used to speed lifesaving new treatments to market," the wrote.

Now, however, the 21st Century Cures Act seeks to undo these changes, they argue, largely by reducing standards that will endanger the public. The act "could substantially lower the standards for approval of many medical products, potentially placing patients at unnecessary risk of injury or death," they noted. "While the legislation does not mandate this approach, it opens the door to it."

The also write that approval standards for medical devices would be lowered even further than for medications, and they are already lower as it is.

You can read the full column here.

Sources:

http://energycommerce.house.gov/press-release/21st-century-cures-act

http://www.nytimes.com

http://www.nejm.org/doi/full/10.1056/NEJMp1506964#t=article

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