In one of their last moves of the year, U.S. lawmakers cleared legislation designed to boost medical innovation and stem the growing opioid abuse crisis. President Barack Obama signed the 21st Century Cures Act into law on Dec. 13.
The bipartisan legislation authorizes $6.3 billion over 10 years to be funneled to the National Institutes of Health, the Food & Drug Administration, and states. But the money is not guaranteed. Congress would still need to approve the funding each year.
About $4.8 billion of the money is authorized for NIH to fund a cancer initiative, a genomics-based precision medicine effort, and research on the human brain. Another $1 billion would go to states to help deal with opioid addiction. The remaining funds are slated for FDA to accelerate the approval of new drugs and devices and to hire new scientists, doctors, and engineers.
Spearheaded by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.), the law aims to include patient experiences in the drug approval process and bring cures to patients faster. To do so, it reduces the amount of data pharmaceutical companies need to provide to FDA to support the approval of certain new drugs. For example, the legislation allows FDA to accelerate the approval of regenerative therapies, and in some cases use data summaries in lieu of full clinical trial data. It also allows drug companies to market their products “off label” for uses that have not been approved by FDA.
Opponents of the legislation are calling such provisions a huge giveaway to the pharmaceutical industry. “The legislation includes 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,” says Michael Carome, Director of the Public Citizen’s Health Research Group, a consumer advocacy organization.
The pharmaceutical industry is welcoming the new law. “The legislation includes pro-patient, science-based reforms which enhance the competitive market for biopharmaceuticals and drive greater efficiency in drug development,” says Pharmaceutical Research & Manufacturers of America CEO Stephen J. Ubl. “It also increases FDA’s regulatory capabilities to foster the timely review and approval of new treatments for patients.”