The 21st Century Cures Act, which has reached the Senate this week after overwhelming bipartisan support in the House, represents a landmark in funding for biomedical research, $5-billion to be exact, as well as its initiatives on brain research and genomics-based “precision medicine.” It will also almost certainly be approved by President Obama. But, is that all this bill is? Could it be that straight forward?
What the Cures Act actually is, is a huge deregulatory giveaway for Big Pharma and the medical device industry.
From the article:
“This continues a trend of eroding standards at the Food and Drug Administration since the 1990s,” says Michael Carome, director of the Health Research Group at the advocacy organization Public Citizen, which issued a broadside against the bill last month. “We don’t think there should be any further erosion.”
Moreover, despite the universal praise for provisions for state grants to battle opioid abuse and for mental health research and treatment, it also cuts $3.5 billion, or about 30%, from Obamacare’s Prevention and Public Health Fund, which fosters work to prevent Alzheimer’s disease, hospital-acquired infections and other conditions, according to Kaiser Health News.
(A bit of robbing Peter to pay Paul, eh?)
The 21st Century Cures Act has been attempting to get through Congress since 2015 but this year its promoters decided to combine the rollback of FDA standards with funding for the National Institutes of Health (et voila). That brought lots of Democrats on board and clouded their vision; the extent to which the bill reduces regulations on drug- and medical-device makers is shameful:
- The bill opens a path for the FDA to approve new uses, or indications, for existing drugs without demanding thorough clinical tests conducted along customary lines.
- It also allows drug makers to promote off-label uses of their drugs to insurance companies. This would allow them to vastly expand the markets for these drugs while bypassing FDA scrutiny.
- And it creates what Public Citizen calls an “overly broad” category of “breakthrough devices” that the FDA will be pressured to approve hastily.
There’s a reason that we the people believe Congress and the FDA are owned by Big Pharma and this bill certainly drive that point home. For instance, in 2015 alone the FDA approved 89% of applications for new drug uses. Remember Merck’s Vioxx? A perfect example. The painkiller and arthritis drug, approved by the FDA in 1999, was pulled from the market in 2004 after it was shown to raise the risk of heart attacks. At the time it was pulled 88,000 Americans had heart attacks from taking Vioxx and 38,000 of them were fatal. And yet it had made it through the hasty process in place at the FDA, which may now be even hastier…all in the name of profit. Not our health, but profit.
You can bet we will be paying attention to this and will update you as we have more information.
Source: LA Times