The 21st Century Cures Act: Smoke, Mirrors, and De-Regulation

It would only be fair to give Congress the benefit of the doubt and at least assume they had the best intentions when crafting the 21st Century Cures Act, and it is worth recognizing the small miracle that was Republicans and Democrats agreeing on a bill President Obama would sign.

Selling point number one is that the bill increases funding for mental health services including badly needed psychiatric hospital beds and addiction treatment programs for young patients. Another laudable accomplishment is the strengthening of mental health parity regulations, which require insurers to treat mental health the same way they treat other medical issues.

The act also includes grants for suicide prevention and intervention programs, de-escalation training for law enforcement, and establishes the position of a new Department of Health and Human Services assistant secretary in charge of mental health and substance use disorders.

In terms of raw numbers, the bill gives an extra $4.8 billion to the National Institute of Health for precision medicine and biomedical research, including $1.5 billion for brain disease research and $1.8 billion for cancer research dubbed the “Beau Biden Cancer Moonshot” in honor of Joe Biden’s son who died of brain cancer in 2015.

On the other hand, the 21st Century Cures Act also includes some substantial deregulations — a necessity to get Congressional Republicans on board. The act deregulates the process for FDA approval of new medications, a change that will allow drugs that haven’t been through a clinical trial to be approved and sent to market.

The act also allows researchers to waive the “informed consent” requirement for medical research, opening the door for patients to become unwitting subjects in new research so long as proper protocols are followed and patients continue to receive the medically accepted standard of care.

Additionally, all of the funding included in the 21st Century Cures Act is subject to yearly appropriation through the Congressional budget process. This has the potential to undermine many of the primary reasons why Democrats and President Obama got on board with the bill, as any future Congress could simply refuse to appropriate the funds resulting in all of the deregulation occurring with none of the additional funding going through.

That was essentially the argument made by the five Senators who voted against the bill, Ron Wyden (D-OR), Jeff Merkley (D-OR), Mike Lee (R-UT), Bernie Sanders (I-VT), and Elizabeth Warren (D-MA), who bluntly stated that the bill had been “hijacked” by the pharmaceutical industry.

Regardless, President Obama signed the bill into law on December 13, 2016, temporarily alleviating the political pressure for D.C. to “do something” about the growing opioid epidemic ravaging America’s rural communities.