The 21st Century Cures Act will speed up FDA approvals, and could accelerate advances to save lives.
Whether the bill, which is on the floor of the House of Representatives this week, will do as it intended remains to be seen.
Some critics say faster doesn’t necessarily mean better, when it comes healing.
“(Congress says) it will benefit patients, but it was written primarily by pharmaceutical and device companies and reflects their desire to get medical products approved on the basis of skimpier evidence than the law currently requires,” said the National Centers for Health Research, a non-profit think-tank organizing some opposition to the act.
Some supporters of the bill have stated that FDA approval of vital drugs takes too long currently – as much as 15 years, in some cases. But opponents have pointed out that the FDA moves as fast as any other regulating agency of its kind – and the safeguards in place developed over time, for a reason, according to a pair of doctors writing recently in the New England Journal of Medicine.
“Over the past 80 years, this country’s regulatory approach has embraced steadily improving criteria for accurately assessing therapeutic efficacy and risk,” wrote Jerry Avorn, of the Harvard Medical School, in an editorial. “Patients and physicians would not benefit from legislation that instead of catapulting us into the future, could actually bring back some of the problems we thought we had left behind in the 20th century.”
But many outside organizations see too many potential positives, and have thrown their support behind the bill. Groups such as the Friends of Cancer Research, the Pharmaceutical Research and Manufacturers of America, even the Mayo Clinic have announced their full support of the bill and the faster changes it will bring.
“We are particularly pleased to see the draft’s emphasis on reducing regulatory barriers that unnecessarily slow clinical trials,” said John Noseworthy, the Mayo Clinic CEO. “We also are very encouraged by the committee’s efforts to increase funding for the National Institutes of Health, which Mayo Clinic believes is an essential national investment.”
Nonetheless, politics will its part in the approval of the bipartisan bill, known as “Cures” by many of its supporters. Several accounts stated that it will have significant majority of support in the House, where it is sponsored by Rep. Diana DeGette (D-Colorado) and Rep. Fred Upton (R-Michigan).
“America can be – and must be – the healthcare innovation capital of the world,” said DeGette, in a recent promotional video for the bill with Upton.
The bill’s Congressional supporters also tout its provisions as being primarily self-funding. But some opponents say the changes might throw away precisely what is currently working within the healthcare system currently.
Filed Under: Drug Discovery