Washington — The U.S. House will consider a bill that would speed up the process for federal approval of new medical treatments and devices on Thursday and Friday.
The bipartisan push for passage is led by the bill’s architects, U.S. Reps. Fred Upton, R-St. Joseph, and Diana DeGette, D-Colorado.
Upton, who chairs the Energy & Commerce Committee, says he wants a “strong vote” with the support of nearly 70 percent of House members “to help us move the bill through the Senate and get it to the president’s desk.”
“Ten-thousand different diseases – 7,000 of them rare. Only 500 cures. We can do better, and that’s what this bill does,” Upton told reporters Wednesday.
In May, the bill, known as 21st Century Cures, was approved by Upton’s committee on a 51-0 vote, following a compromise among lawmakers around how to pay for the legislation. The bill provides $550 million to the Food and Drug Administration over five years to reform and modernize programs and $10 billion for the National Institutes of Health.
The initiatives are paid for in part by drawing down and selling excess crude oil from the Strategic Petroleum Reserve; adjusting the timing of pre-payments to prescription drug sponsors through Medicare Part D; and limiting Medicaid reimbursement rates for durable medical equipment.
“The savings exceed expenditures, not just in the first 10 years but obviously in a 20-year window as well,” Upton said.
The Obama administration disagreed Wednesday with Upton’s assessment that the legislation pays for itself. While the Office of Management and Budget did not threaten a presidential veto, it said the proposed new responsibilities for the FDA “exceed the resources provided in the bill” and that it doesn’t want to sell oil from the Strategic Petroleum Reserve.
The Obama administration welcomed the legislation’s “bipartisan support for medical research” and pledged to work with Congress on the bill. But the Democratic administration listed many objections, including that the legislation “could undermine regulatory standards by allowing unproven uses of therapies to be marketed to health care payors as though such uses had been proven safe and effective.”
Upton and DeGette and committee staffers spent a year and a half meeting with experts from the research community, FDA, NIH, disease groups and patients to gather ideas on how Congress could help expedite the approval of drugs and devices.
Their bill would streamline clinical trials and provide incentives for companies to research and repurpose drugs approved to treat rare diseases. It also encourages greater patient input before and during drug development. More than 250 patient groups have endorsed the bill, which has 230 co-sponsors.
“This bill is all about spending money more effectively and more efficiently,” Rep. Pete Sessions, R-Texas, said Wednesday afternoon at a Rules Committee hearing on the bill.
But Rep. Alcee Hastings, D-Florida, lamented that the bill has been “weighed down” by last-minute policy riders such as one to prohibit federal funding for abortions.
Critics are concerned the legislation puts too much pressure on the FDA to lower its standards for evaluating new drugs and treatments and could put vulnerable patients at risk.
“We all want new cures, of course, but just because a drug is new doesn’t mean it’s a cure. That’s the big ‘if’ here,” said Diana Zuckerman, president of the nonpartisan National Center for Health Research, which does not accept money from pharmaceutical and other industry groups with a financial stake in its research.
“Studies would be smaller and for a shorter term, and would not necessarily look at patients’ health but at killing bacteria in a test tube or shrinking tumors in a rat. ... It basically lowers the standards to a point where they’re meaningless.”
Other groups, including the consumer advocacy organization Public Citizen, say the bill would weaken the reporting requirements under the Physician Payment Sunshine Act, allowing for speaker fees and gifts to physicians from pharmaceutical and medical device companies if those contributions are related to medical education or the practice of medicine.
A corresponding bill has not been introduced in the Senate.