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The U.S. Senate has confirmed Stephen Hahn as the next commissioner of the FDA, bringing to a close a process that was unofficially in the works for approximately three months. Hahn takes the helm of an agency that has a number of controversial tasks before it, including the precertification program for software as a medical device and the ethylene oxide (EtO) problem.
The Dec. 12 Senate vote tallied at 72 votes to confirm and 18 to oppose, with Sens. Patty Murray (D-Wash.) and Tina Smith (D-Minn.) voting in opposition. Murray, Smith and Sen. Elizabeth Warren (D-Mass.) were the three authors of the correspondence with the FDA regarding the precertification program, but the Senate scorecard indicates that Warren did not take part in the vote, likely due to her campaign for the party’s nomination for next year’s presidential election.
Hahn takes the job at a time of increasing restiveness on Capitol Hill on several fronts, including the e-cigarette/vaping problem and the ongoing struggle to get ahead of the opioid epidemic. Drug pricing is a hotly debated issue on Capitol Hill as well, with reimportation only one of several proposals making the round in the House and Senate. Another issue – one over which the FDA has no control, but about which Hahn might nonetheless hear – is that the latest negotiation over the U.S.-Mexico-Canada Agreement on trade would leave each of the member nations at liberty to set their own policies regarding biotechnology patent exclusivity, a move adamantly opposed by industry.
While the problems surrounding medical device safety are largely the administrative province of Jeff Shuren, director of the Center for Devices and Radiological Health, some of these issues will likely require Hahn’s time and attention as he grapples with the varying imperatives at play in Congress. The EtO controversy shows no signs of abating despite that the Environmental Protection Agency has issued an advanced notice of proposed rulemaking on the question, a process that will likely run through most of 2020 before drawing to a conclusion.
EPA Posts Notice of Proposed Rule for Ethylene Oxide
Expectations regarding the EPA’s advanced notice of proposed rulemaking (ANPRM) for the use of EtO in medical device sterilization might have carried the hopes and fears of a wide range of stakeholders, including fears of much stricter regulation. That particular concern does not appear well founded at present, but a number of members of Congress are forming their own group to address the use of EtO in an effort to drive a more aggressive regulatory stance toward the sterilant.
The EPA posted a Dec. 5 press release making note of the FDA’s activity in this area, but also calling for nominations to a small business panel that would advise the agency on any impact a final rule would have on small entities. In addition to reviewing the existing regulations governing EtO, EPA will work with state and local agencies to determine whether immediate steps are needed to deal with any potential health hazards. EPA administrator Andrew Wheeler also pointedly referred to the importance of this chemical to public health, likely a nod to the medical device sterilization question.
The reaction on Capitol Hill to the EPA document is likely to be driven by a group of House members, numbering fewer than 10 as of late November, whose opposition to the use of the sterilant is a matter of record. In a Nov. 20 statement, the Ethylene Oxide Task Force said it will push legislation that would require the EPA to issue “strict” EtO emission standards. H.R. 1152 has struggled to gain traction since its introduction in February, however, and the bill’s listing at Congress.gov indicates that the companion Senate bill (S. 458) enjoys the sponsorship only of Illinois Democrats Dick Durbin and Tammy Duckworth.
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