By Clinical Informatics News Staff

December 7, 2016 | The United States Senate just approved the 21^st Century Cures Act in a 94-5 vote. The omnibus bill passed the House of Representatives last summer by a wide margin. The vote today also reflects bipartisan support. Passage of the Act “signals an encouraging moment for the nation that their government can make progress on behalf of the American people,” said the Bipartisan Policy Center in a press release immediately after the vote.

Several lawmakers called the passage “groundbreaking”, saying that the Cures Act is one of the most important pieces of legislation this year.

“Ultimately, this legislation will accelerate the discovery, development and delivery of new drugs and devices in a safe and effective manner and modernize the Food and Drug Administration,” said former FDA Commissioner Andrew von Eschenbach, in the BPC press release. von Eschenbach serves on BPC’s medical innovation initiative advisory committee.

But not everyone’s happy.

Last summer, Gregg Gonsalves, co-director of the Yale Global Health Partnership, told Clinical Informatics News that the Act would lower the standards for FDA drug approval. “The bill is superfluous and unnecessary,” he said. “Approvals from FDA are already the fastest in the world, as compared to other regulatory agencies, and the percentage of drug applications receiving approval has reached a new high in 2015.”

Gonsalves cautioned that the Act follows a wave of legislation since the 1980s and 90s meant to weaken the safety and efficacy requirements at the Agency. “The bill would make mere clinical experience acceptable for evaluating new drugs, rather than rigorous clinical trials, force the use of biomarkers for a wide variety of conditions on terms largely set by industry, and even let manufacturers make changes in medical devices without FDA review,” he explained.

After months of debate, the same objections stand.

On Monday, Derek Lowe, at Inside the Pipeline, raised similar concerns about FDA’s perceived efficiency. “There’s some fundamental confusion here,” Lowe writes. “I really don’t think that there’s this huge backlog of wonderful therapies piling up behind a big FDA roadblock. FDA approval is not what shows that a drug works; clinical data do that. You can instruct everyone to collect less data, but then you will approve – and ask people and their insurance companies to pay for – more things that don’t actually work.”

But there’s much more to the Cures Act than just clinical trials. Lowe compared the Act to a party game: “Bills like this are giant piñatas, and all kinds of stuff falls out of them when they’re whacked,” Lowe observed of the 1,000+ page Act: “Anyone who tells you that they’re on top of the whole thing is probably bluffing.”

It’s the “all kinds of stuff” that has critics worried. The Cures Act is full of pieces to which one can object. Last week, NPR broke down the “winners” and “losers” under the Act. NPR called pharmaceutical companies, medical schools, hospitals, patient groups, and health-IT companies winners. Losers include groups that lobbied against the Act including other consumer and patient safety groups and the FDA itself.

“The bill gives the FDA an additional $500 million through 2026 and more hiring power, but critics say it isn’t enough to cover the additional workload under the bill. The agency also got something it opposed: renewal of a controversial voucher program that awards companies that approve drugs for rare pediatric diseases,” the authors observed.

Rachel Sachs, an Associate Professor at the Washington University in St. Louis School of Law, spared no vitriol at Harvard Law School’s Bill of Health blog. “The 21st Century Cures Act envisions a system in which the FDA approves many more drugs whose efficacy has not yet been tested in the real world – and thus envisions a system in which the right number of approved unsafe, ineffective drugs is much higher than it is right now,” she wrote on Monday.  

The Cures Act is divvying up a lot of money: the $500 million for FDA, $4.8 billion to National Institutes of Health, and $1 billion in state grants over two years to address opioid abuse. It strips some funding too though; the Cures Act cuts $3.5 billion from the Prevention and Public Health Fund established under the Affordable Care Act.

The LA Times sees it all as little more than a shell trick. “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,” LA Times reporters write.

And that’s no secret. In a largely-congratulatory statement issued by the American Association for Cancer Research this afternoon, AACR warns about funding drop offs.

“The National Institutes of Health (NIH) Innovation Account, established by Cures, provides $4.8 billion in supplemental funding for important medical research programs, of which $1.8 billion over seven years is to support cancer research through the “Beau Biden Cancer Moonshot.” This targeted, multi-year funding will help support the 10 cutting-edge scientific recommendations identified by the National Cancer Moonshot Initiative Blue Ribbon Panel for realizing the Vice President’s goal of achieving 10 years of progress within the next five years,” AACR’s statement reads.

“However, it is vitally important that the NIH also receive robust, sustained, and predictable annual funding increases, and therefore, we call on Congress to make sure that the funds for medical research that are included in the Cures Act are in addition to the money NIH receives each year through the regular appropriations process.”

The Cures Act now proceeds to the Oval Office. President Obama has praised the Cures Act and the White House issued a statement this afternoon leaving little doubt that the President will sign the Cures Act into law.

“We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer’s, and helping people seeking treatment for opioid addiction finally get the help they need. The bipartisan passage of the 21st Century Cures Act is an example of the progress we can make when people from both parties work together to improve the health of our families, friends and neighbors,” the President’s statement reads.