Two key lawmakers said they intend to incorporate ideas that would hasten device development into legislation expected out early next year under the 21st Century Cures initiative. Among the ideas are centralization of Institutional Review Board approvals and removal of Health Insurance Portability and Accountability Act (HIPAA) privacy provisions that stand in the way of medical researchers sharing data from large trials and registries.

The information-gathering phase of the House Energy and Commerce Committee’s 21st Century Cures project is coming to an end and draft legislation incorporating ideas from the months of hearings is expected out by January, Committee Chairman Fred Upton, R-Mich., signaled during a Sept. 10 roundtable on Capitol Hill.

During the roundtable, FDA Commissioner Margaret Hamburg also pledged to “forcefully” address recruitment and retention of agency staff; a 25 percent device reviewer turnover rate was cited. Lawmakers and others at the hearing also emphasized the need for more stable funding for medical research at the National Institutes of Health and FDA to accelerate development of modern cures and technology.

“We intend to release a Cures legislative discussion draft in early January 2015 and will look to swiftly move the legislation early in the next Congress,” Upton said in his opening statement. “If you want your idea considered, please send it to cures@mail.house.gov as soon as possible. The more specific the idea, the better.”

Regional events are likely to occur once Congress adjourns again for campaign season, but the roundtable in the committee room was a fitting climax to a listening tour that has won accolades from across the ideological spectrum. HHS Secretary Sylvia Burwell offered some brief congratulatory remarks at the beginning of the event, and specifically praised two medtech advances: development of nanotechnology for device use, and the ReWalk Robotics’ ReWalk exoskeleton that allows paraplegics to walk. (See [A#01140630014].)

Local IRB Process Slows Device Trials

Dean Kamen, founder of medtech invention firm Deka R&D Corp., complained Sept. 10 that one of the barriers to completing device trials in a timely fashion was the need for researchers to gain approval from each local institutional review board at multiple sites for the trial. Rep. Diana DeGette, D-Colo., who co-chairs the 21^st Century Cures project, said that the group had “discussed the potential for time- and cost-savings of a centralized IRB process – something that I have been working on for a long time.”

Hamburg agreed, and tasked Committee Chair Upton to make a change to existing medical device law: “There is something Congress can do … there is a device clinical trials requirement that a local IRB has to agree to approve such trials,” she said. “If Congress could remove that, it would help.”

“Done,” agreed Upton.

A couple of participants also concurred that changes need to be made to HIPAA privacy laws to allow for greater data sharing of trial and registry results. DeGette emphasized the need for data and information sharing among clinical registries, while venture capitalist Michael Milken, chairman of The Milken Institute remarked: “We have to think about ways to waive HIPAA provisions” on privacy rights “for data collection.”

Upton also agreed this was an important idea, likely to be addressed in next year’s legislative package.

Waxman Cautious About Government Activism

If the committee drafters want to maintain the bipartisan support the 21stCentury Cures initiative has enjoyed so far, they may need to take a moderate approach to reform, Ranking Member Henry Waxman, D-Calif., said. Waxman, for example, cautioned moderation on some ideas raised at past roundtables, such as proposed bill (H.R. 5214) to make electronic health records interoperable with ongoing device and drug registries. (See [A#01140811001].)

Rep. Waxman warned against coming in “with a blunt instrument, suddenly recreating the FDA authorities or mandating things for FDA or … the Department of Health and Human Services to do… “I think we have to be cautious about some the legislation that may be proposed,” he said.

Waxman’s fear of unintended consequences may seem unusual for someone who often advocates for an active government role in addressing societal problems, but he noted that one of the major reforms at FDA in recent decades, the creation of drug accelerated approval, was spurred on by AIDS activists, and not by legislation.

“The people that brought home the reform at FDA, that got some of these therapies out quickly, were the ACT UP group and the gay community,” he said. “They studied the law of FDA and argued, ‘You don’t need to take so long, you don’t have to wait to the end result to show that the therapy is safe and effective, you can have markers to get these products out more quickly.’”

Waxman’s hesitancy about the need for fundamental FDA reform may be shared by other Democrats, especially as the agency seems poised to experience a multi-year upswing in the number of approvals. But Waxman won’t be around to advocate for it as any legislation moves through committee; he’s retiring at the end of the term. (See Also see "Longtime House Member Henry Waxman To Retire" - Medtech Insight, 3 February, 2014..)

Another health policy guru who was present at the roundtable but will be gone next year is Rep. Phil Gingrey, R-Ga. Gingrey, who is also retiring, was a key supporter of the SOFTWARE Act introduced by Rep. Marsha Blackburn, R-Tenn., last October, to limit FDA oversight of the health information technology industry. (See Also see "Bipartisan House Bill Introduced To Curb FDA Health IT Oversight" - Medtech Insight, 23 October, 2013..)

IRB, HIPAA Changes To Be Folded Into 21st Century Cures Bill Next Year

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