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Regulatory News | 09 February 2016 | By Zachary Brennan
The Senate Health, Education Labor & Pensions Committee (HELP) on Tuesday advanced seven bills that could serve as piecemeal counterparts to House-passed Cures legislation from last year.
The swath of new bills would, among other things, streamline the US Food and Drug Administration’s (FDA) review process for innovative medical devices, bolster FDA's oversight of reusable devices, accelerate the approval process for some “targeted” rare disease drugs and aid the National Institutes of Health (NIH) efforts in early research.
HELP Chairman Lamar Alexander (R-TN) sounded optimistic about the prospects of each of the bills.
Sen. Elizabeth Warren (D-MA) also made clear that the “need for strong biomedical innovation is urgent,” but that a “handful of small, targeted changes won’t get us where we need to be.”
“We need to strengthen FDA,” Warren said, noting that a Republican push to reduce the bar for approving drugs or devices and “neutering the FDA is reckless.”
This bill, introduced in September, would amend the Federal Food, Drug, and Cosmetic Act to require FDA to allow sponsors to use previously submitted data or data from another sponsor “with a contractual right of reference” to that data in order to speed the review and approval of rare disease treatments.
The bill would only apply to a drug that incorporates or utilizes “the same or similar genetically targeted technology, or the same variant protein targeted technology, as the drug or drugs that are the subject of an application or applications.”
Sen. Michael Bennet (D-CO), one of the bill’s four sponsors, explained on Tuesday that the bill solves a complex problem as some of the drugs used to treat rare diseases “can be easily tweaked” to serve larger patient populations. Bennet did not offer any examples of such drugs, though he said several Duchenne muscular dystrophy (DMD) patients pushed for him to introduce the bill.
Much like the House-passed Cures legislation from last year, this bill aims to reduce “unnecessary burdens in device evaluations and streamlining the review process for clinical trials.” In addition, the bill seeks to modernize the regulation of diagnostic tests.
More specifically, the bill would ensure additional training for FDA officials on premarket device submissions, allow medical device clinical trial sponsors to use a central Institutional Review Board so multi-center trials can be run, and require FDA to publish revised guidance on in vitro diagnostic devices and waivers under the Clinical Laboratory Improvement Amendments of 1988.
The Advanced Medical Technology Association (AdvaMed), a device industry group, commended the Senate HELP committee’s passage of the bill, noting it “includes common-sense reforms to eliminate redundant requirements at the agency and to help improve the agency’s medical technology review process.”
The bill, introduced by Sen. Patty Murray (D-WA), would help improve the safety of reusable medical devices after contaminated devices known as duodenoscopes were linked to life-threatening, antibiotic-resistant infections.
Murray released a report on the issue in January, finding that FDA’s post-market surveillance system for tracking medical devices is ineffective. FDA, for its part, has called out some of the most egregious offenders and said they need to submit plans to conduct safety studies on their devices.
In addition, the HELP committee advanced:
On 9 March, the HELP committee will also meet to address five other bills: The Advancing Hope Act of 2015 (S. 1878), the Medical Electronic Data Technology Enhancement for Consumer’s Health (MEDTECH) Act (S. 1101), the Medical Countermeasures Innovation Act of 2015 (S. 2055), the Combination Products Innovation Act of 2015 (S.1767) and the Advancing Breakthrough Medical Devices for Patients Act of 2015 (S.1077).
The committee will also meet on 24 February to discuss the Zika virus.
Tags: Senate HELP committee, drug legislation, device legislation, NIH legislation, FDA bills