Congress Passes 21st Century Cures Bill

Disclosures

December 07, 2016

A bipartisan, $6.3 billion bill that speeds up drug approvals, funds research in cancer and brain science, strengthens mental healthcare, and combats opioid abuse won overwhelming approval in the Senate today. It now goes to President Barack Obama for his promised signature.

The measure, dubbed the 21st Century Cures Act, passed the House of Representatives last week in a 392 to 26 vote. Today's margin of victory in the Senate, 94 to 5, was just as overwhelming. Casting the "no" votes were Sen. Mike Lee (R-UT), Sen. Jeff Merkley (D-OR), Sen. Bernie Sanders (I-VT), Sen. Elizabeth Warren (D-MA), and Sen. Ron Wyden (D-OR).

A broad swath of the healthcare industry supported the Cures bill. Medical societies on board included the American Psychiatric Association, the American Society of Clinical Oncology, and the American Gastroenterological Association. The bill also enjoyed the backing of the American Heart Association, the Arthritis Foundation, the Association of American Medical Colleges, and, not surprisingly, the Pharmaceutical Research and Manufacturers of America, the trade group for drug makers.

Most of the Cures money — $4.8 billion — goes to the National Institutes of Health (NIH) for research that includes the Cancer Moonshot, the Precision Medicine Initiative, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, and regenerative medicine. Senate Republicans renamed the portion of the bill directing $1.8 billion to the Obama administration's Cancer Moonshot and its quest for a cure after Beau Biden, the son of Vice President Joe Biden. Beau Biden died of brain cancer last year, and his father has led the Obama administration's Moonshot initiative.

The mental health provisions of the Cures bill fund suicide-prevention programs, mental health services for children, and programs for court-ordered outpatient treatment. It reinforces current laws that require insurers to treat mental illness as they do any other illness in terms of benefits. And it creates a new position in the US Department of Health and Human Services called the Assistant Secretary for Mental Health and Substance Use for coordinating mental health programs across the federal government.

The federal campaign to treat and prevent opioid abuse receives an infusion of $1 billion from the Cures bill. The beneficiaries are state programs that monitor drug prescribing, treat individuals addicted to prescription drugs, and train clinicians.

"21st Century Christmas Tree Act"?

The centerpiece of the 21st Century Cures Act is provisions that would speed up the development and approval of new drugs and medical devices by the US Food and Drug Administration (FDA). The legislation puts less emphasis, for example, on randomized clinical trials in FDA reviews of new indications for a drug already on the market. Instead, the bill encourages the FDA to use "real-world evidence," such as data from observational trials and insurance claims.

The bill also would expand the use of "biomarkers" — a metabolite, for example — to judge drug efficacy as opposed to more traditional endpoints in medical research, such as more months of life or fewer complications.

The congressional authors of the bill contend that in determining a product's efficacy and safety, the FDA often doesn't recognize valid sources of data generated by new technologies. The FDA needs to modernize its vetting process, they say, to enable manufacturers to keep pace with rivals in Asia and Europe.

Not everyone is swooning over the Cures legislation. The consumer watchdog group Public Citizen and the National Center for Health Research have issued "speed kills" warnings. They've argued that the measure will lower the regulatory bar, resulting in less safe and effective products reaching the market.

A 2015 editorial in the trade publication Modern Healthcare reached the same conclusion and called the bill the "21st Century Quackery Act." A Modern Healthcare editorial last week changed the moniker to "The 21st Century Christmas Tree Act," explaining that provisions such as increased funding for NIH research and the campaign against opioid abuse are "stocking stuffers" that mask the original intent of the bill.

Cures defenders counter that the FDA will remain faithful to its mission of protecting the public. Those defenders include two former FDA commissioners, Mark McClellan, MD, and Andy von Eschenbach, MD, both of whom served during the George W. Bush administration.

Dr McClellan said in a cowritten Huffington Post article that "the bill will allow the FDA to utilize today's rapidly evolving science to support the (safety and efficacy) standard, while explicitly prohibiting the agency from approving a drug based on a lower standard of evidence." And in the online Morning Consult, Dr von Eschenbach said that "a modernized regulatory process can assure every American that they will have access to medical products they need as rapidly and safely as possible, using the best technology available."

Follow Robert Lowes on Twitter @LowesRobert

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