Legislation for the 21st Century Cures program produced an avalanche of support from patients and the life science industries, and the House of Representatives responded with a 344-77 vote in favor of H.R. 6, which now moves to the Senate with a $9 billion price tag. One question is how the Senate will handle its end of the task, but the White House threw a damper on the celebration via a July 9 press release stating that President Obama “has concerns about providing additional funding” to the NIH “without addressing sequestration more broadly.”

The White House statement includes references to patient input into regulatory decisionmaking at FDA, and states that the administration “in particular . . . appreciates the legislation’s support for the President’s Precision Medicine initiative.” The statement claims that a failure to tackle the sequester threatens “not only NIH research, but also other investments in innovation.” The letter registers the President’s objections to the use of inventory in the Strategic Petroleum Reserve as part of the pay-for in H.R. 6 as well.

The administration also pointed out that the measure underfunds the tasks FDA would be charged with, and the President added that H.R. 6 “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.”

The first failed amendment to H.R. 6 came from Rep. David Brat (R-Va.), who voiced opposition to “the creation of a new mandatory program.” Brat, whose amendment has widely been described as a poison pill, said his offering introduces “a bit of reason to the budget process of the United States,” adding that by 2027, “all federal revenues will be spent only on mandatory programs,” leaving “zero dollars for running the government.”

House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said he “strongly oppose[s] this amendment because making this funding discretionary” would delete potential savings to entitlement spending. Upton said CBO has projected “this bill would reduce the deficit by some $500 million-plus” in the first few years, and then save the taxpayer another $7 billion in the second decade. The legislation, however, offers only five years of financing for NIH and other agencies. Brat’s amendment went down with more than 140 aye votes, only half the 281 votes registered against the measure.

Former Energy and Commerce Chairman Rep. Joe Barton (R-Texas) decried the calls for offsets and other measures that might thwart the bill, stating that Medicare Part D had no offsets. He said the underlying legislation for Part D had support from nearly all Republicans and almost none from Democrats. Barton added, “I wish the entire federal government were discretionary except for Social Security, but it’s not. Let’s come together” and “vote for something we can all be proud of,” Barton urged the House.

Rep. Michael Fitzpatrick (R-Pa.) offered an amendment to address what he described as “the tragedy surrounding power morcellators.” Fitzpatrick’s amendment essentially lent support to the use of unique device identifiers at the point of care in electronic health record systems, which “could significantly enhance the availability of medical device data” for postmarket surveillance, according to the legislative record.

“What happened with the power morcellator should never be allowed to happen again,” Fitzpatrick stated, citing the 2011 IOM study of the 510(k) process as corroboration of a purportedly broken review mechanism. “It’s time we take our medical device safety regulations into the 21st Century,” Fitzpatrick urged. That amendment passed on a voice vote.

Rep. Jared Polis (D-Colo.) came up with a medical device-related amendment that ran in a somewhat different direction, an interesting development given that Polis’ home state is not known for being a particularly device-intensive locale. He said Congress “should start thinking about what the next step is” in clearing out regulatory impediments, suggesting a two-tiered approval process for devices, which in this framework would be approved based on safety, then monitored for efficacy, essentially replicating the system used in the European Union.

Polis said a device-maker might need $30-100 million to get a device to market in the U.S., adding, “in the European market, [the device] reaches market in seven to 11 months,” but the same device might need up to four years in the U.S. “simply because our own government is keeping that product off the market even though that product is safe.”

The amendment would create a two-tiered process for review of device applications, and mandate that FDA turn out a report on the potential impact of such an approach. Polis said, “provisional marking of the product in American can and will save lives,” but the proposal drew only modest support. Upton said “the issue has merit, but we have to make sure it’s designed the right way.” Upton indicated that the amendment was late to the process, but said he would work with Polis on the concept.

Rep. Frank Pallone (D-N.J.) seconded Upton’s comments, stating, “we do understand the purpose of the Polis amendment,” vowing that he would support “follow-up, and have perhaps a meeting with FDA as well.”

Steve Ubl, president and CEO of the Advanced Medical Technology Association, said H.R. 6 “represents an important and significant first step toward strengthening the American innovation ecosystem.” He cited the expedited path for devices designated by FDA as breakthrough technologies, but added that the legislation “also provides resources to FDA to implement these important reforms” along with insulation of user fees from the sequester. However, Ubl said the association opposes provisions that would apply Medicare payment rates to durable medical equipment in the Medicaid program.

Jim Greenwood, president and CEO of the Biotechnology Industry Organization, said H.R. 6 “prioritizes placing patients at the center of the drug development process, which we believe will help spur the development of therapies for the most prevalent conditions, as well as encourage development of treatments focused on unmet medical needs.” Greenwood also supported the legislation’s insulation of user fees from the sequester.
Mark Leahey, President/CEO of the Medical Device Manufacturers Association (MDMA), said the association “thanks Chairman Upton and Congresswoman (Diana) DeGette (D-Colo.) for their bipartisan leadership on the ‘21st Century Cures Act’ to speed up the discovery of and access to medical technologies for patients and providers.” Leahey said MDMA “will continue to work with members of Congress to improve” the bill as the Senate works on its own version, “and to help ensure that the final legislation spurs innovation and patient care.”