In a week dotted with big news for the life science industries, the passage of 21st Century Cures legislation in the House of Representatives is perhaps the biggest. Investors and industry are understandably enthused at the development, but opponents, including Senate Democrat Elizabeth Warren of Massachusetts, are blasting the legislation as a grab bag for industry that exposes patients to greater risk. (See story this issue.)

The 21st Century Cures Act of 2016 requires FDA reviewers to engage in formal training regarding the least burdensome standard for review of drugs and devices, but the volume threshold for humanitarian device exemptions would be doubled to 8,000 patients per year. The House bill calls on the FDA to expand its pool of employees with expertise in a variety of clinical and non-clinical areas – and to boost salaries for these experts – much or all of which presumably would be covered by the additional $500 million the agency would receive in the coming decade.

The National Institutes of Health would be the recipient of an additional $4.8 billion over 10 years, $1.8 billion of which will be applied to the Cancer Moonshot program. The states will receive $1 billion to aid their efforts to deal with opioid drug abuse, but one of the sticking points for many of the bill's critics is that NIH funding would remain in the category of discretionary spending rather than mandatory spending.

Section 3053 of the Cures Act seems to push FDA to recognize more international standards pertaining to medical devices and diagnostics, which some have argued is an area in which FDA tends to drag its feet. On the other hand, the agency recently signed off on a guidance published by the International Medical Device Regulator's Forum on software as a medical device, suggesting the agency's device center was already moving in that direction.

Michael Carome of D.C.-based Public Citizen said the legislation consists largely of "a grab bag of goodies for Big Pharma and medical device companies that would undermine requirements for ensuring safe and effective drugs and medical devices." Carome was likely referring to the NIH discretionary/mandatory debate with the comment that there is "no guarantee that this [NIH] funding will be appropriated by Congress in future years."

The Medical Device Manufacturers Association had released a formal statement noting the association's support of the bill, but MDMA President/CEO Mark Leahey told Medical Device Daily that the bill "contains a number of critical provisions to improve the efficiency and predictability of the medical device review process, including a new regulatory pathway for certain breakthrough devices." Leahey also pointed to the legislation's "reimbursement reforms that will require more transparency and process improvements by local Medicare administrative contractors and CMS."

Leahey made reference to the Cure's text calling for expanded emphasis on patient perspectives on regulatory decisions, stating that in the aggregate, the Cures Act's features "have the potential to deliver on the bipartisan goal of increasing access to safe and effective medical technologies for patients and providers." The net effect will be to allow the device industry "to continue extending life expectancies, improving the quality of life and reducing the costs of treating chronic conditions," Leahey concluded.

The Biotechnology Innovation Organization (BIO) said that the legislation furthers the collaboration between industry and government in the area of medical countermeasures for man-made and naturally-occurring threats. BIO CEO Jim Greenwood added that the organization is "pleased about the focus on precision medicine through genomics and regulatory science." Greenwood also applauded the increased monies for the FDA designated for the hire of "world-class scientific experts," and said BIO members "appreciate the important first steps" designed to increase the disclosure of health care economic information with payers.

Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), said that passage of the bill "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." Whitaker made reference to the bipartisan participation in the drafting of the bill, thanking Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) "for their leadership in spearheading the 21st Century Cures initiative." Whitaker concluded, "we urge the Senate to promptly take action to pass this legislation so that patients everywhere can benefit from the next generation of life-changing innovations."

Among the investors who sounded off on the passage of the 21st Century Cures Act of 2016 was the National Venture Capital Association, which said that the increased funding for the National Institutes of Health and for the Precision Medicine Initiative would go a long way toward "improving the environment for the development of life-saving drugs and treatments," which NVCA President and CEO Bobby Franklin said "is critical to ensuring the U.S. remains the global hub of medical innovation."

However, Franklin also said the association remains concerned about "the unpredictability of regulation and the uncertainty of reimbursement policies."