As 2016 came to a close, the U.S. House of Representatives overwhelmingly approved the 21st Century Cures Act by a vote of 392–26, and the Senate passed it by a vote of 94–5. The Act, which was strongly supported by the device industry, is the result of a two-year effort to identify ways to invest in research and make the approval process for medical technologies and pharmaceuticals more efficient and effective. It is designed to accelerate the discovery, development, and delivery of new cures and treatments by
- Modernizing clinical trials and the means by which safety and efficacy data is accumulated and analyzed.
- Putting patients at the heart of the regulatory review process.
- Supporting broader, more collaborative development, qualification, and utilization of biomarkers, which help assess how a therapy is working, and on whom, earlier in the process.
- Streamlining regulations and providing more clarity and consistency for innovators developing health software and mobile medical apps, combination products, vaccines, and regenerative medicine therapies.
- Incentivizing the development of drugs for pediatric diseases and medical countermeasures, and empowering FDA to utilize flexible approaches in reviewing medical devices that represent breakthrough technologies.
- Providing FDA with $500 million for regulatory modernization and giving the agency the ability to recruit and retain the best and brightest scientists, doctors, and engineers.
A key driver behind the Act is the desire to maintain America’s global status as the leader in biomedical innovation, a position that has been threatened for years by a burdensome and slow approvals process. The Act ensures that the U.S. remains a leader in medical treatment and innovation through more funding for medical research, modernizing FDA, and streamlining the medical device review process, according to Congressman Erik Paulsen, who voted for the bill.
Scott Whitaker, president and CEO of AdvaMed, called the passage of this legislation “a milestone in improving the innovation ecosystem for medical technology and ensuring the availability of new lifesaving, life-enhancing devices and diagnostics for patients.”
The bill is not without its critics, though, who cast it is a blank check to the medical device and pharma industries to circumvent the FDA approval process. Senator Elizabeth Warren raised significant concerns about the bill, saying that it “offers to sell government favors. It delivers a special deal so people can sell these treatments without meeting the FDA gold standards for protecting patient safety.”
“Congress shouldn’t be in the business of selling FDA favors to the highest bidder, risking people’s lives to enrich political donors,” she says.
Despite such concerns, the bill has the potential to be a really great win for industry. At the end of the day, it is up to each medical device manufacturer to act responsibility and to prove the critics wrong. Read the bill here.
Editor and Director of Medical Content