House Considers Speeding Drug Development as Opposition Mounts
The U.S. House of Representatives is expected to pass legislation to speed drug development and increase funding for medical research, even as leaders from both parties have voiced reservations.
The bill, known as the 21st Century Cures Act, would streamline clinical trials, offer drugmakers incentives to develop new antibiotics and exempt the emerging diagnostic software industry from oversight by the Food and Drug Administration. The measure would also bolster research at the National Institutes of Health, including creating an innovation fund totaling $9.3 billion for fiscal years 2016 to 2020.
While a vote on the bill is scheduled for Friday, senators have yet to produce their version of the legislation. And the White House came out Wednesday against some provisions in the bill, signaling a steeper uphill climb than originally anticipated for the bipartisan measure in the House. The bill, introduced by Michigan Republican Fred Upton, has 230 co-sponsors.
The White House is concerned the $550 million allocated through 2020 to help the FDA implement the bill won’t be enough, according to a statement of administration policy released Wednesday. Offering drugmakers an incentive to study drugs for rare diseases by extending their time on the market without generic competition will increase drug costs, the White House said.
The administration also took issue with selling oil from the Strategic Petroleum Reserve to help pay for new measures in the bill. The Heritage Foundation, a conservative think tank in Washington, argued funds from the sale of oil should go to pay down the deficit.
Pharmaceutical Research and Manufacturers of America, which represents drugmakers such as Pfizer Inc. and Sanofi, has shown support for the measure, as has the American Medical Association and AARP, the nation’s largest senior citizen advocacy group.
Public Citizen and Consumers Union, both of which are advocacy and watchdog groups, said
the legislation would undermine the FDA’s ability to ensure drugs and
medical devices are safe and effective. The bill has lower standards for
antibiotics and a lower bar for approval of devices, they said. https://www.mql5.com/en/signals/111434