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08 December 2016

United States: $5 Billion 21st Century Cures Act Is a Huge Handout to the Drug and Medical Device Industries

Rep. Tim Murphy (R-Pa.), left, embraces Rep. Fred Upton
(R-Mich.), the sponsor of the 21st Century Cures Act.
(Susan Walsh / Associated Press)
No provision for prevention in this bill. It cuts $3.5 billion, or about 30%, from Obamacare’s Prevention and Public Health Fund. It favors Big Pharma, the medical device industry, computer, software, and telecoms companies, among others. It is an offense to consumer and patient safety groups, reducing regulations on drug and medical devices and failing to lower the high prices of medications.

Column : The 21st Century Cures Act: A huge handout to the drug industry disguised as a pro-research bounty
by Michael HiltzikContact Reporter, latimes.com, 5 December 2016

The problem with bills in Congress that roar toward passage like juggernauts is that they’re especially worthy of close examination, and especially unlikely to get it. That’s the story with the 21st Century Cures Act, which reaches the Senate this week after achieving overwhelming bipartisan support in the House. Almost certain approval by President Obama lies on the horizon.

To judge from the huzzahs, the Cures Act represents a landmark in funding for biomedical research — a $5-billion bounty for the Obama administration’s “cancer moonshot” as well as its initiatives on brain research and genomics-based “precision medicine.”

“Simply put: 21st Century Cures is an innovative game-changer and a truly once-in-a-generation opportunity to bring our healthcare system light years ahead of where it is today,” proclaimed Rep. Fred Upton (R-Mich.), the measure’s chief sponsor in the House. The measure is due for a vote in the Senate on Monday closing debate, with a vote for enactment likely later in the week. [UPDATE: The Senate passed the bill Wednesday afternoon and sent it to the White House.]

This continues a trend of eroding standards at the Food and Drug Administration since the 1990s.— Michael Carome, Public Citizen

If universal praise for a measure makes your B.S. detectors twitch, you’re on the right track. The 21st Century Cures Act is a huge deregulatory giveaway to the pharmaceutical and medical device industry, papered over by new funding for those research initiatives. The punchline is that the regulatory rollback is real, but the funding may not be — it’s subject over the next decade to annual appropriations by Congress that might never come.

“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.

One would expect Congress to ask the drug industry for something in return for regulatory rollbacks of this magnitude. Remarkably, nothing in the measure would address the main problem the public sees with the drug industry — inordinately high prices.

“When American voters say Congress is owned by big companies,” Sen. Elizabeth Warren (D-Mass.), said from the floor last week, “this bill is exactly what they are talking about.”

The 21st Century Cures Act has been meandering through Congress at least since 2015. But it was only this year that its promoters hatched the idea of combining the rollback of FDA standards with funding for the National Institutes of Health, which long has been starved of resources. That prospect brought many Democrats on board.

It may also have clouded their vision, leaving unnoticed the extent to which the bill reduces regulations on drug- and medical-device makers.

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. These include randomized samples, to prove they’re safe and effective for the new indications. Instead, the FDA could rely on “real world evidence,” which includes observations, safety and side-effect claims, and other data not subject to rigorous analysis. “That’s a much lower level of evidence,” Carome says.

"A homeopath would love this provision, and, I’m sure, so would drug companies," David Gorski, an oncologist and prominent debunker of pseudoscience and medical nostrums, wrote last year. "Why bother with the time, bother and expense of those pesky clinical trials to get your drug approved for additional indications, when you can rely on clinical experiences?”

"The bill 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. 

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