Cures Act Is Bad Medicine for NIH, FDA

(Photo: AP/Bill Clark/CQ Roll Call)

Senate Majority Leader Mitch McConnell, flanked by Senators John Cornyn, John Barrasso, and Roger Wicker, leaves the podium after speaking with the press after the Senate Republicans' caucus lunch on November 29, 2016. McConnell inserted into the 21st Century Cures Act a provision that would accelerate the approval of untested regenerative therapies that are labeled "a moderate risk."

Not too long ago, most political observers expected a lively, lame-duck Congress. Would President Obama muscle through the Trans-Pacific Partnership trade agreement? Would the Senate, wary of a Hillary Clinton Supreme Court nominee, confirm Merrick Garland? Would Republicans pass a year-long budget to keep Clinton’s hands away from the fiscal cookie jar?

All that changed after the election. Now the lame-duck Congress is a sleepy affair, with Republicans looking ahead to the ascension of Donald Trump. But there’s one exception to this legislative lethargy: The 21st Century Cures Act, a bill with a bipartisan pedigree that has now become a wet kiss to the pharmaceutical lobby and other trade groups. Liberal Democrats have finally begun to sound the alarm, but with others, including Obama, behind it, and votes scheduled on the bill, will they be too late?

The 21st Century Cures Act came into being as a feel-good measure. After all, who doesn’t like cures? The core elements represented a trade-off: Democrats wanted additional research and development into cures for diseases like cancer and Alzheimer’s at the National Institutes of Health (NIH), and Republicans wanted a faster way to get those solutions into patients’ hands. Other provisions created incentives to cures for rare diseases, supported the research of young scientists, and enhanced collaborations between researchers.

The Cures Act passed the House Energy and Commerce Committee 51–0, and secured broad bipartisan support in the House in July. The bill stalled in the Senate, but Republicans in both chambers released a revamped version late last week, aiming for a lame-duck triumph. The House will vote Wednesday, and the Senate afterward. “America’s patients are waiting on us and we will deliver,” the bill’s leading Republican proponents, Representative Fred Upton of Michigan and Senator Lamar Alexander of Tennessee, said in a statement.

The new package satisfies a few Democratic goals. It would allocate $4.8 billion to the NIH for research on personalized medicine, Alzheimer’s disease, adult stem cells, and Joe Biden’s “Cancer Moonshot.” It would also provide $1 billion in grants to fight the opioid epidemic and $500 million for the Food and Drug Administration (FDA). There are also some popular proposals that would reform foster care and treatment of mental illnesses.

But this relatively meager set of provisions shields the real objective: New sources of cash for corporations. The Cures Act would severely undermine the FDA by altering its drug and medical device approval process to value speed over accuracy and profits over health and safety. In response to corporate complaints that FDA approvals are costly and time-consuming, the bill would reduce standards, streamline reviews, secure automatic approval for certain devices and drug therapies without rigorous screening, and allow the use of “real world” evidence of drug effectiveness rather than more credible randomized clinical trials. Third parties could certify certain medical devices, avoiding the FDA entirely. Even articles from medical journals could be used as evidence, despite an uptick in retractions in these publications in recent years.

Set aside for a moment that drug approvals in the United States are actually the fastest in the developed world. The FDA already has plenty of tools to speed a vital drug to market. They can expedite approval for essential drugs that would affect competition and affordability. They can temporarily import approved drugs from overseas. Congress can also use the existing Bayh-Dole Act to allow drugs created in federally funded research programs to be made available on “reasonable terms.” All of these existing measures would get life-saving medications to patients more quickly and actually make them affordable.

Instead, the Cures Act approach would compromise the FDA process for nearly all new products. The proposals could lead to ineffective and even hazardous treatments and a return to the old days of quack cures and snake oil. Harvard’s Daniel Carpenter calls it the “19th Century Fraud Act.” Moreover, rather than intervening to make drugs affordable, the bill saves drug companies from compliance costs. That’s probably why the Cures Act has 1,455 lobbyists representing 400 different corporations working on its passage. It is one of the most lobbied bills in recent memory. PhRMA, the drug industry trade group, has spent $24.7 million alone on its lobbying effort.

Wait, there’s more: Section 4009 of the bill would exempt physicians from current requirements to disclose speaking fees and other payments for “medical education” events. This provision amounts to a “Secret Bribes to Doctors Act,” which would advance the influence-peddling game medical companies use to get their products prescribed. Even Republican Senator Chuck Grassley of Iowa has expressed anger about the proposed change.

Another provision, inserted at the request of Senate Majority Leader Mitch McConnell, would accelerate approval of untested regenerative therapies as long as they are labeled a “moderate risk,” the lowest classification with the least stringent regulatory requirements. This measure would directly benefit Ed Bosarge, a wealthy Republican donor who has heavily invested in regenerative medicine. There’s also a carve-out for hospital-owned, outpatient facilities to get larger reimbursements and for long-term care hospitals to delay a penalty that would cut into their profits.

The much-ballyhooed funding for Democratic priorities is not a win-win. First off, $3.5 billion of the $6.3 billion price tag is paid for through a raid on the Affordable Care Act’s prevention fund, part of which was supposed to go to preventing diseases like Alzheimer’s and cancer. So the money earmarked for prevention goes to fund research into cures of the same maladies. Another $1 billion comes from selling off oil from the Strategic Petroleum Reserve. Still more comes from reducing certain Medicare and Medicaid payments. Section 5011 rescinds $464 million in health-care funding that would have gone to cash-strapped Puerto Rico to subsidize Obamacare exchange purchases.

Plus, the $4.8 billion in NIH funding (down from an original $8.75 billion) actually expires after five years, and doesn’t offset rapid declines in NIH spending over the past decade. According to a Public Citizen analysis, “The bill sets a bad precedent for the future by trading temporary incremental research funding with permanent changes that weaken FDA oversight.”

The Obama administration gave muted praise to the Cures Act when it passed the House, but now the White House “strongly supports passage,” according to The Huffington Post’s Sam Stein. But Democratic liberals in the Senate have rushed to oppose it. In a searing Monday floor speech, Elizabeth Warren called the bill “extortion,” trading a few dollars for bipartisan priorities in order “to make it easier for giant drug companies to commit fraud, give out kickbacks, and put patients’ lives at risk.” Bernie Sanders also rejected the Cures Act, because of its “numerous corporate giveaways.”

Democrats have a choice: They can take their sliver of temporary social spending and tout it as the best they can do, or permanently obliterate the effectiveness of the FDA, and compromise the health and safety of patients nationwide. Donald Trump and his appointees can mess with the FDA all by themselves. There’s no reason for President Obama and Democrats in Congress and to help them out.

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