21st Century Cures Act Signed into Law

In a show of bipartisanship and further support of precision medicine and health care innovation—including genomics and other diagnostic innovations, the 21st Century Cures Act has become law. After the House of Representatives and Senate overwhelmingly voted to approve the legislation, President Obama signed it into law on Dec. 13, 2016.

Billions of dollars of funding will support precision medicine initiatives and other efforts to discover, develop and deliver treatments and cures for cancer, Alzheimer's and rare diseases. As the American Clinical Laboratory Association pointed out in a 2014 letter to the Energy and Commerce Committee supporting the 21st Century Cures legislation, diagnostics "are an essential component to providing the most effective and highest quality care" with laboratory testing innovations helping physicians by "providing more accurate diagnoses, quicker; allowing physicians and patients to choose the best treatment, first and sooner."

There are four main parts to the legislation: Part I addresses discovery, innovation and opioid abuse; Part II addresses research and development, patient access to new products, protection for human research subjects, and data sharing; Part III addresses health care delivery, interoperability and telehealth; and Part IV addresses Medicare and Medicaid reforms. Here are some highlights of the legislation:

• $4.8 billion in funding for NIH; funds will in part support the Precision Medicine Initiative ($1.5 billion) and the Cancer Moonshot ($1.8 billion)

• $500 million for the FDA to modernize its regulatory efforts and secure the best talent

• Measures that promote electronic health records and interoperability so patient care is seamless

• $1 billion to states for opioid abuse prevention and treatment programs including improvement of drug monitoring programs

Summing up comments of many stakeholders in the life sciences industry, AdvaMed praised the law stating: "Passage of this important legislation is a milestone in improving the innovation ecosystem for medical technology and ensuring the availability of new life-saving, life-enhancing devices and diagnostics for patients."

But not all are happy with the legislation. An online opinion article in STAT criticizes what it claims are weakened FDA oversight measures for new drugs and devices: "These provisions would unravel the FDA, turning it from the treatment watchdog it is today into a puppet of the pharmaceutical and medical device industry. If the 21st Century Cures Act is passed as written, clinicians could be given potentially deadly drugs and devices to prescribe to their patients, blessed by this new version of FDA approval."

Takeaway: Precision medicine initiatives get a significant show of support from both political parties.