The 21st Century Cures Act slashes FDA’s approval process to speed up the cash flow into Big Pharma’s coffers.
“At a time when Americans pay, by far, the highest prices in the world for prescription drugs, this bill provides absolutely no relief for soaring drug prices. The greed of the pharmaceutical industry has no limit, and this bill includes numerous corporate giveaways that will make drug companies even richer… It’s time for Congress to stand up to the world’s biggest pharmaceutical companies, not give them more handouts.” Bernie Sanders
“The idea that industry is just in this to peddle toxic drugs to sick people is absurd,” Mary Woolley, Director, Research America, a big recipient of $$$ from the industry.
The Cures Act fails to halt extortionist drug prices in the US; instead it will lead to an avalanche of new, high priced drugs that will not have passed scientific safety and efficacy tests. The legislation will likely shift the costs of drugs o Medicare recipients.
The Act’s linguistic hyperbole: approval will be based on “real world evidence” translates to mean reliance on anecdotal evidence and small clinical trials which cannot by design detect serious safety problems. Furthermore, if primary endpoints (e.g., survival) failed to be met, surrogate (secondary, often inconsequential) endpoints will be accepted. The 21st Century Act will also allow manufacturers to make changes in their products without any FDA oversight.
If passed, the 21st Century Cures Act would result in an avalanche of unsafe, unproven, potentially deadly drugs and devices onto the market while misleading physicians and patients with a degraded seal of FDA approval.
Pro Publica provides sobering insight about the heavy duty lobbying and public relations campaign mounted by the pharmaceutical and medical device industry to insure passage of this deregulation profit boosting bonanza. The Act passed the House by a lopsided 344 to 77 vote in July, and has, if anything, gained momentum.
“The list of entities lobbying on the bill now runs to about 1,800 quarterly entries in the Senate’s lobbying database, with more than 1,100 lobbyists registered as working on it, which is staggering even by the standards of Washington.”
The bill has garnered an unusually broad range of “bipartisan” support, thanks to lavish cash contributions. Another cash incentive that has helped the legislation gain broad support is that lawmakers softened up the usual opponents of deregulation with a big carrot — billions of dollars in new federal medical research funding for the National Institutes of Health.
The bill’s support comes from both Republican and Democrat lawmakers whose election campaign coffers are filled to the brim with PhRMa cash; both conservative and left leaning think tanks, the White House, and a host of industry-funded “patient disease advocacy” groups and nonprofit organizations, including those who are typically leery of deregulatory efforts by industry. Also on board are the academics who supplement their government grants with hefty consulting and speaking fees from industry.
The legislation has benefited from the “neutral sheen” provided by the support of “patient advocacy” groups, think tanks, and academic institutions whose financial dependence on both government and industry is glossed over as if it has no bearing.
Pro Publica describes how the overlap was on display at the annual luncheon in Washington for one of the nonprofit groups backing the bill, Research America. “dozens of industry officials, patient advocates and academic researchers mingled with the event’s sponsors, which included the drug companies Astellas, Shire, Janssen, Celgene and Gilead, as well as AdvaMed, the device lobby… throughout the event there was a steady drumbeat urging those in attendance to keep pushing Congress to pass 21st Century Cures.”
A recent analysis by Forbes found that so far this year the FDA has rejected only three never-before marketed drugs, and approved 25, an approval rate of 89% up from 66% just seven years ago. “We’re the fastest regulatory agency in the world,” said Gregg Gonsalves, a prominent HIV activist now working as a research scholar at Yale Law School. “Pharma would just be very pleased to do less work for more gain.”
“We definitely need more effective drugs, but just calling something effective doesn’t make it so. It’s a little like gluing some feathers together and calling it a duck. Most drugs that go into studies don’t make it — not because the FDA is too strict — but because they don’t just work.” David Ross, former director of FDA drug evaluation. (Alec MacGillis, Pro Publica, Nov 30, 2016)
“I will fight it because I know the difference between compromise and extortion.” Elizabeth Warren
A cautionary tale of a truncated FDA approval process
Twenty years ago the biotechnology industry’s lobbying efforts succeeded in derailing FDA’s science-based approval policy for genetically engineered food products – whose identity has been hidden from the American public, as these products are not labeled.