GOP leaders predict House passage of medical research bill

Joy Montgomery
December 2, 2016

A bipartisan-backed new version of the 21st Century Cures Act, created to accelerate medical device and drug approvals and boost research spending, is up for a crucial vote in the U.S. House of Representatives this week.

Yet the strong bipartisan vote in the House, coupled with support from the White House and industry, will likely mean "Cures" passes easily in the Republican-controlled Senate. Among other things, this legislation supports that a good fraction of research will come from public US agencies such as the National Institutes of Health.

"We feel that we're on good footing", Rep. Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee, said of the bill's prospects in both the House and Senate.

· Provides $500 million over 10 years to the Food and Drug Administration. The legislation calls for the FDA to evaluate the potential use of "real world evidence", such as patient registries, observational studies and claims. The legislation also provides $1 billion to states to supplement opioid abuse prevention and treatment activities, such as improving prescription drug monitoring programs (PDMPs). "This legislation breaks down regulatory barriers and expedites the approvals for drugs and devices coupled with billions for more research", Upton said during House debate on the bill prior to the vote. The Cures Act includes an approval pathway allowing smaller clinical trials for antibacterial drugs that can treat infections that are resistant to existing treatments.

"ASCO is particularly pleased that the bill takes a step forward in addressing the interoperability of electronic health records (EHRs) and that the legislation puts restrictions on intentional information blocking", he added.

Despite pushback from local addiction treatment groups and the unanimous approval of Massachusetts Democrats in the House, Warren stood by her opposition to the health care bill, which was passed overwhelmingly Wednesday in the lower chamber.

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Unlike the earlier bill, the House measure has no language protecting drugmakers' patents for longer periods.

No. 2 Senate Democratic leader Richard Durbin of IL said he was "totally underwhelmed" by the bill's extra money, and said its cuts in a disease prevention fund created under Obama's health care law to finance new medical research displayed "a warped sense of justice".

"As with any piece of legislation that is passed by a Republican Congress and signed into law by a Democratic president, it's going to require some compromise", White House spokesman Josh Earnest said Wednesday.

The 21 Century Cures Act seeks to ease the path to FDA approval for drug and device companies, but if Sen. Another $1 billion is included to fund opioid abuse, which has become a health crisis in states like West Virginia, Kentucky and New Hampshire. One major change since then is the removal of a provision to allow more secrecy around the payments that drug and device companies give to doctors under the description of "continuing medical education." Sen.

"It invests the $1 billion the President has repeatedly said is necessary to help communities that have seen far too many overdoses". They say it's a giveaway to drug companies. Elizabeth WarrenElizabeth WarrenTop union considers endorsing Ellison for Dem Party boss: report Warren pushes Dems to get tough with Trump Axelrod mocks Trump's "diverse Cabinet" MORE (D-Mass.) and Bernie SandersBernie SandersSanders: Carrier took Trump hostage and won Trump's vow on Medicare in doubt after HHS choice Axelrod mocks Trump's "diverse Cabinet" MORE (I-Vt.) have blasted it as a giveaway to pharmaceutical companies.

Specifically, the bill will help progress various industry initiatives, all aiming to bring cures to diseases that afflict a significant population. That looming transition has greatly reduced the leverage of Democrats, who would have preferred the bill to contain more money and greater consumer protections.

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