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Washington โ€” The U.S. House approved Friday a landmark bill to expedite federal review of new medical treatments and devices and infuse the National Institutes of Health with $8.7 billion for disease research.

The legislation's architect, U.S. Rep. Fred Upton, R-St. Joseph, worked on the bill for a year and a half and ended up receiving overwhelming bipartisan support, as the House approved the bill in a 344-77 vote.

Upton, chair of the House Energy & Commerce Committee, made a heartfelt pitch for his colleagues' votes Thursday night, noting that each of their lives has been touched by disease in some way, and that cures are still far too rare.

"We have all said too many early goodbyes to people we treasure," Upton said on the floor, his voice shaking with emotion.

"This bill is about making sure our laws, regulations and resources keep pace with scientific advances."

He displayed a large poster of two sisters who inspired him โ€” Brielle and Brooke Kennedy of Mattawan, ages 7 and 6, who have a rare, genetic muscle-wasting condition called type II spinal muscular atrophy, for which there is no known cure or treatment.

He has previously spoken of his cousin's daughter, Ele Stover, who passed away at 11 months of age in 1989 after being struck with a serious illness.

"The 21st Century Cures initiative is for them. It's for those we've lost, those who grapple with sickness today, and those who will be diagnosed tomorrow," Upton said.

Upton's partner on the bill, Rep. Diana DeGette, D-Colorado, also personalized the issue, speaking Thursday of her father-in-law, who died 25 years ago from ALS or Lou Gehrig's disease.

"We have made almost no progress on a cure," DeGette said. "A healthier world is coming, and I look forward to getting there as fast as we can."

The bill, known as 21st Century Cures, provides $550 million to the Food and Drug Administration over five years to reform and modernize programs and $8.7 billion for the National Institutes of Health.

The legislation was approved by Upton's committee in May on a 51-0 vote, following a compromise among lawmakers about how to pay for the legislation.

The initiatives would be funded 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.

Some Republicans on Friday objected to the bill's mandatory funding mechanisms, saying they should instead be discretionary. Upton called the proposed amendment a "poison pill" that would undermine the legislation.

The House rejected the amendment by a nearly 2-1 ratio, and 70 Republicans ultimately voted against the underlying bill, including Rep. Justin Amash, R-Cascade Township. The Michigan delegation's five Democrats all supported the overall legislation.

But Democrats objected to language tacked on to the legislation that, among other things, would prohibit the use of certain federal funds for abortion โ€“ a longtime practice of Republican anti-abortion lawmakers.

"It's yet another attempt to insert abortion restrictions ... into what is an otherwise unrelated bill," said Rep. Barbara Jean Lee, D-California, who proposed an amendment to remove the policy riders. Her amendment failed by a vote of 245-176.

The Obama administration has said the legislation does not pay for itself. The White House has not threatened a presidential veto, but says the proposed new responsibilities for the FDA "exceed the resources provided" and that it doesn't want to sell oil from the Strategic Petroleum Reserve.

Regarding the oil sales, Upton told reporters after the vote that "this is an issue I think we can work through."

The administration also listed 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."

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.

Upton and DeGette said the committee worked closely with former FDA Commissioner Andy C. von Eschenbach, a physician, and feel "quite strongly" that the bill would not weaken the standards for drugs and devices.

The bill would streamline clinical trials and provide incentives for companies to research and repurpose drugs approved to treat rare diseases. It also would encourage greater patient input before and during drug development. More than 250 patient groups have endorsed the bill.

Upton said mandatory funding for NIH research and "knowing it was paid for" brought the two sides together and allowed for the bill's success.

Starting Friday afternoon, Upton and DeGette said they would begin working with leadership and their counterparts in the Senate, where a corresponding bill has not been introduced.

"We're not expecting a similar work product. Ours is very comprehensive at 344 pages long. We're hoping they can expand on what we've done with relevant provisions, so we can go to conference," Upton said.

"We're not expecting any hangups, that we're aware of."

mburke@detroitnews.com

(202) 662-8736

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