The US Senate has passed the 21st Century Cure Act which could have significant implications for the regulation of both medical devices and medicines.
The legislation outlines how new drugs and medical devices can gain FDA approval much faster.
According to the Wall Street Journal (WSJ) the, “passage of legislation aimed at speeding up Food and Drug Administration approvals, combined with an incoming president who has pledged to ‘cut red tape’ at the agency, is expected to usher in a new, more industry-friendly era of drug and device regulation.”
Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), commented: “AdvaMed commends the Senate for passing this important piece of legislation. The 21st Century Cures Act is a win for patients and for medical innovation. When fully implemented, this legislation will help accelerate the discovery, development and delivery of medical advancements to ensure more timely access to new treatments and cures for patients in need.
“AdvaMed has been a strong proponent of the 21st Century Cures Initiative from its earliest stages. We are pleased that this legislation – which will have such a positive impact for patients and the American innovation ecosystem – has passed one more hurdle to becoming a reality.”
The bill also has the support of the Pharmaceutical Research and Manufacturers of America (PhRMA). President and CEO Stephen Ubl said: “PhRMA applauds the House of Representatives for passing the bipartisan 21st Century Cures Act to improve the discovery and development of new medicines for patients. The legislation includes pro-patient, science-based reforms which enhance the competitive market for biopharmaceuticals and drive greater efficiency in drug development. It also increases FDA’s regulatory capabilities to foster the timely review and approval of new treatments for patients.”
According to Reuters the legislation will speed up the process for medical device and drug approval “in part by allowing clinical trials to be designed with fewer patients and cheaper, easier-to-achieve goals”.
Not everyone has come out in support of the bill and there are fears that the legislation could lead to less stringent criteria being applied to new device and drug approvals.
Public Citizen, a lobbying group which describes itself as ‘serving the people’s voice in the nation’s capital’ released the following statement:
“It is sorely disappointing that Congress gave Big Pharma and the medical device industry an early Christmas present by passing the 21st Century Cures Act. This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices.
However, because of the efforts of Public Citizen and allies, Big Pharma and medical device corporations did not receive all the goodies they put on their long wish list. Our pressure helped eliminate provisions that would have 1) opened a gaping hole in the Physician Payments Sunshine Act for educational gifts made by industry to physicians; 2) increased medication prices and cost taxpayers an estimated $12 billion over 10 years; 3) encouraged hospitals to overuse the newest antibiotics thereby contributing to the harmful spread of antibiotic resistance; and 4) allowed medical device manufacturers to make changes to high-risk medical devices without U.S. Food and Drug Administration oversight.
The bill passed does less harm than the original bill that passed the House last summer, but Congress should not have had to jeopardise patient safety to increase medical research funding.”