Note: This statement was revised to correct the list of leaders who released the discussion draft.
April 29, 2015
Revised 21st Century Cures Proposal Still Would Put Patients at Risk and Undermine Safety
Statement of Vijay Das, Healthcare Policy Advocate, Public Citizen’s Congress Watch Division
Note: Today, U.S. Reps. Fred Upton (R-Mich.), Diana DeGette (D-Colo.), Frank Pallone, Jr. (D-N.J.), Joe Pitts (R-Pa.) and Gene Green (D-Texas) released a discussion draft of their 21st Century Cures legislative package.
Like an earlier draft, the newly introduced 21st Century Cures legislative proposal continues to be riddled with dangerous provisions that would put patients at risk. Despite Rep. Upton’s intention to capture input from public health professionals and consumer and patient safety experts, this draft remains an assault on patient safety and science.
The 21st Century Cures initiative offers a horse trade: Increase funding for the world-renowned National Institutes of Health (NIH) in exchange for providing perks to the pharmaceutical and medical device industries to approve medications and devices faster based on weaker evidence. This is not a way forward. Faster approval of new medicines will not spur innovation, but it will sacrifice safety. Passage of this legislation would put lives at risk.
On the rising global threat of antibiotic resistance, the bill would lower the U.S. Food and Drug Administration (FDA) approval standards for new antibiotics and offers financial rewards that would encourage overprescribing of new antibiotics, which would only exacerbate the problem.
New antibiotics that improve patient outcomes are needed, but the key bottlenecks to research and development are scientific not regulatory. The best way to attack this threat is: 1) to slow the development of antibiotic resistance, use antibiotics only when medically required; and 2) invest in the development of safe treatments.
If we want to appropriately address public health threats like antibiotic resistance, we should properly contend with them. In this case we should address the increasing overuse of antibiotics and support the Helping Effective Antibiotics Last (HEAL) Act (H.R. 931), which would complement recent executive actions on the threat of antibiotic-resistant pathogens. Unlike the ideas offered in today’s 21st Century Cures package, the HEAL Act would protect patients throughout the FDA approval process while boosting the development of proven and safe new antibiotics.
Congress should move forward with ideas offered in measures likes the HEAL Act, which align with President Obama’s plan to address the rising threat of antibiotic resistance. They should not support the 21st Century Cures draft legislation.
We cannot hold NIH funding hostage in the false pursuit of science and medical breakthroughs while undermining safety.
The president’s best course of action is to veto the 21st Century Cures deregulatory effort making its way through Congress.
Additional material regarding the 21st Century Cures Act:
Read a May 19, 2015, Public Citizen joint letter regarding 21st Century Cures legislation.
View a letter sent to U.S. House of Representative members detailing concerns with the 21st Century Cures Act.
View a factsheet on clinical trial data sharing.
View a factsheet on the dangerous antibotic Bedaquiline, which the FDA approved in 2012.
The New England Journal of Medicine: “The 21st Century Cures Act – Will It Take Us Back in time?“
The New York Times: “Don’t Weaken the F.D.A.’s Drug Approval Process“