House to vote this week on 21st Century Cures Act

The U.S. House of Representatives is set to vote this week on the 21st Century Cures Act, which looks to speed up FDA approval of both new drugs and devices, as well as provide a boost in funding for medical research.

Leaders of the House and Senate said late on Friday they worked out a deal to pass the legislation, according to Stat News, though a final version of the bill is still in negotiation with Senate democrats.

The House will vote on the approximately $6.3 billion legislation, which would provide $500 million for the FDA and $1 billion to battling the opioid epidemic. The legislation also includes $4.8 billion to support 3 Obama administration research programs over 10 years – VP Biden’s cancer moonshot, the BRAIN Initiative and the Precision Medicine Initiative.

Much of the bill focuses on the FDA, including provisions to establish an expedited review for breakthrough devices, hastening reviews of drug-device combos and increasing patient participation in drug approvals.

The bill would also require the FDA to evaluate the use of “real world” evidence to support new uses and post-approval studies for previously approved drugs, as opposed to the gold standard of randomized clinical trials.

Medtech industry lobby group Advamed, which allegedly held regular, private meetings to help write the bill, posted a release supporting the passing of the Act.

“The package includes a number of important improvements to FDA’s medical device premarket program designed to increase the efficiency, predictability and transparency of the agency’s review process. The most significant of these builds on initiatives already underway within FDA to help create an expedited pathway for breakthrough medical technologies – those that offer the best hope for patients with life-threatening or irreversibly debilitating diseases or conditions who have no or limited alternative treatment options,” AdvaMed wrote in a press release. “We urge Congress to take action of this important legislation as soon as possible for the benefit of patients everywhere.”

The bill, which was developed by the House Energy & Commercial Committee, passed the U.S. House of Representatives 344-77 last July.

The 21st Century Claims Act has been highly praised and criticized since it was brought forth. Last July, the New York Times published op-eds which slammed and praised the Cures Act, with sides claiming it would severely weaken, or transversely strengthen, the FDA.

Last December, the act drew criticism from consumer watchdogs and FDA experts after it was revealed that there was an unprecedented level of collaboration between the federal safety watchdog and the industry it regulates.

FDA documents released late last year showed collaboration between the FDA and the medical lobbying group, AdvaMed, even while Congress was holding public roundtables about the bill, according to BloombergBusiness.

The FDA’s Center for Devices & Radiological Health and AdvaMed “worked together on the proposed language for most of the device provisions in” the Cures Act, according to an FDA memo from an Aug. 7 meeting attended by Dr. Robert Califf, the cardiologist nominated by who President Barack Obama to be the FDA’s new commissioner. Executives from Johnson & Johnson(NYSE:JNJ) and St. Jude Medical (NYSE:STJ) also attended, BloombergBusiness reported.

“For the Senate version of 21st Century Cures, CDRH is currently working with AdvaMed to refine their regulatory strategy in a way that is agreeable to both parties,” according to the August meeting memo.

AdvaMed spokeswoman Wanda Moebius told the news service that the creation of the 21st Century Cures bill was a “very open and inclusive process collecting input across the health care community via written statements, town hall meetings, roundtables and hearings.”

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