$6.3 billion 21st Century Cures Act passes in big win for drug companies, device makers

The U.S. Senate has approved a bill aimed at speeding up regulatory approval for pharmaceuticals and medical devices, as well as providing extra funding for medical research, the Precision Medicine Initiative and the cancer “moonshot.”

What’s been labeled as a $6.3 billion “medical innovation package” had passed the House in a different form in 2015, but the Senate had never considered that version, opting for a piecemeal approach. A revamped bill sailed through the House by a vote of 392-26 on Nov. 30, with the Senate following suit Dec. 7 with a similarly lopsided 94-5 vote.

President Barack Obama has promised to sign the legislation, calling it an “important investment which will save lives.”

“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,” Obama said in a statement.

The bill includes:

• $4.8 billion in additional funding for the National Institutes of Health (NIH), along with funding for research priorities like the cancer “moonshot” and the Precision Medicine Initiative.
• $1 billion in state grants to address opioid abuse and programs to improve mental health care, such as screening pregnant women for depression.
• Requirements for agencies to step up enforcement of laws on equal insurance coverage for mental illnesses.
• $500 million to the Food Drug and Administration in order to change its approval process for devices and drugs. The FDA will be required to consider “patient experience data” as well as clinical trials when considering new drugs or new uses for existing ones. For devices, the FDA will be required to consider the “least burdensome.”

Providing a quicker path to the FDA approval was why Pharmaceutical Research and Manufacturers of America (PhRMA) spent about $30 million lobbying for its passage, along with support from medical device makers.

“Passage of this important legislation is a milestone in improving the innovation ecosystem for medical technology and ensuring the availability of new lifesaving, life-enhancing devices and diagnostics for patients,” Advanced Medical Technology Association President Scott Whitaker said in a statement.

Loosening regulations for pharma and device companies wasn’t without controversy. U.S. Sen. Elizabeth Warren, D-Massachusetts, was one of the few lawmakers who voted against the legislation. She said before the bill’s passage that in exchange for approving medical research funding, Republicans “let Big Pharma hijack” the bill while offering a “fig leaf” to researchers with money that could be cut in future budgets.

“This bill will now become law, and I will keep fighting on these issues—to implement and strengthen the good policies in this bill, to repeal the giveaways and to hold Washington accountable for today’s assurances that it will provide NIH and opioid funding in the future,” Warren said.

Warren said several troubling provisions were stripped from the final bill, including one which would allow drug companies to provide textbooks and journals to physicians without disclosing the payments.

Consumer watchdog group Public Citizen had similar criticisms, calling the legislation an “early Christmas present” for drug lobbyists, but it noted several measures not included in the final version wanted by those companies.

“Our pressure helped eliminate provisions that would have…increased medication prices and cost taxpayers an estimated $12 billion over 10 years, encouraged hospitals to overuse the newest antibiotics thereby contributing to the harmful spread of antibiotic resistance (and) allowed medical device manufacturers to make changes to high-risk medical devices without U.S. Food and Drug Administration oversight,” said Michael Carome, MD, the director of Public Citizen’s Health Research Group.

One category of treatments missed out on faster FDA approval: stem cell therapies. U.S. Sen. Mark Kirk, R-Illinois, who suffered a stroke in 2012, tried to get his legislation allowing the FDA to approve stem cell treatments conditionally without a larger, final-stage clinical trial included in the Cures Act. The effort failed, with only a watered-down provision for accelerated approval in limited circumstances making it into the final bill.