MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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14 | July 2016 T he FDA regulatory scheme for medical devices is largely the product of careful industry building since the lethal damage wrought by the Dalkon Shield intrauterine device provoked Congress to enact the 1976 Medical Device Amendments with FDA holding the keys to market entry. Subsequent mishaps and ambitions brought further industry- tweaked legislative reforms, each crafted and negotiated with potent input from trade associations and lobbyists, and less potent input from medical and patient groups. Now, with the advent of user fees and the quid pro quo FDA per- formance goals that made them politically possible, we have a sys- tem that's substantially the product of successful industry efforts to get inside FDA and build a livable regulatory landscape. It hasn't been a complete takeover as alleged by some critics, but it has slowed the purported exodus of U.S. companies to friendlier regulatory regimes abroad. As a direct result, the CDRH director whose public rhetoric does not extol the benefits of medical device innovation has become an extinct species amid soaring promises of faster, easier product approvals and clearances. But now comes the proverbial fly in the ointment: customer physicians who, energized by patient misadventures with mar- keted devices, see something amiss in this scheme and who take to researching and exposing its weaknesses in the media. The newest is a scathing analysis of FDA's PMA database for obstetric and gynecologic devices during the 2000–2015 timeframe, from ob- stetric-gynecologic physicians and other researchers at Northwestern University's McGaw Medical Center and Feinberg School of Medicine, and the University of Chicago Medical Center, published in the June 2016 issue of the journal Obstetrics & Gynecology. In it, Jessica R. Walter, MD, et al reported that of the 18 device approvals studied, 14 (78%) met their primary clinical efficacy end- point, only 12 were required to conduct postmarket surveillance, 42% were approved on the basis of nonrandomized controlled trials, and three were withdrawn after approval—all of which were either not referred to or not recommended for approval by FDA's obstet- rics and gynecology advisory committee. In other words, these three were approved exclusively on FDA's unaided say-so. The authors say that of these, "two failed to demonstrate clinical benefit in their pivotal trials. One device was not required to undergo postmarketing surveillance and was subsequently withdrawn as a result of patient safety concerns. "Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology de- vices," they wrote. "Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices." In an e-mail response to me, coauthor Steven Xu said, "The prima- ry goal of our paper was to raise awareness within the obstetrics and gynecology community surrounding device regulation and safety." That awareness had already been significantly raised by the multi- media publicity and political efforts, previously reported here, of Phil- adelphia cardiothoracic surgeon Hooman Noorchashm, whose wife, Amy Reed, also a physician, is fighting cancer spread throughout her body by a uterine fibroid ablation device, the power morcellator. Through their combined efforts, aided by a nationwide network of affected patients and sympathizers, U.S. Representatives Michael Fitzpatrick (R-PA), Louise Slaughter (D-NY), and Ryan Zinke (R-MT) introduced two bills in the House of Representatives in June to im- prove medical device safety and allow those harmed by devices to seek legal recourse, overturning industry-supported FDA preemp- tion of state-level liability lawsuits. Their Medical Device Guardians Act (HR 5404) would amend the Food, Drug, and Cosmetic Act to require physicians and physician's offices to be treated as covered device users required to report on certain adverse events involving medical devices. As such, a covered user would be protected from having their reporting to FDA used against them in a civil case. The lawmakers also introduced Ariel Grace's Law (HR 5403), which would allow patients harmed by medical devices to seek legal recourse and compensation for damages. Both bills face heavy resistance from the medical device industry if brought forward. No comparable measures have been introduced in the Senate, although Noorchashm's network is pressing to find sponsors there. Noorchashm, an increasingly severe critic of CDRH management and the obstetric-gynecologic community, developed a form let- ter for his network to use in telling President Obama on the White House website that "the power morcellator disaster demonstrates What Industry Built at FDA, Doctors Try to Tear Down Physicians are identifying flaws in regulatory oversight of medical devices and publicizing their findings. Jim Dickinson Image courtesy of cagan/iSTOcKPHOTO.cOM Washington Wrap-Up

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