Policy Points: Oregon Bio advocates for patient-centered care, repealing the medical device excise tax, and inviting members to review FDA draft guidance for the Safer Technologies Program

Oregon Bio’s public advocacy work on behalf of its members has turned its attention to federal congressional actions. OR Bio members are invited to reach out to their Member of Congress* to learn more about these important, current issues: 

  • Could patient-centered care be outlawed by House Resolution 3 HR3 includes the Lower Drug Costs Now Act 2019, which aims to create reference pricing structures, introduces price control mechanisms from foreign countries, and imposes extreme penalties on U.S. innovation, researchers and drug developers. These penalties are said to include an excise tax of up to 95 percent of manufacturers’ annual, gross sales and severe civil monetary fines.  Oregon Bio is concerned that patients’ access to medicines, decisionmaking between a patient and his/her provider and the path to innovation will be dangerously impeded. U.S. House Majority leader, Steny Hoyer (D-MD 5th District), in a recent letter to congressional colleagues notes  the House may bring HR3 to the floor as soon as Oct. 28. Oregon Bio signed on to a multi-state association letter to House and Senate bipartisan leadership, providing a unified voice from innovative life sciences ecosystems across the country in opposition to this type of dangerous policy. 
  • Ending the ‘punitive’ medical device taxIn September, Oregon Bio signed onto a joint letteralong with a broad, nationwide coalition, requesting prioritization of the repeal of the medical device excise tax, originally enacted in 2013. Since then, the tax has been temporarily suspended after BIO, AdvaMed and many device companies, providers, VCs and biotech interests protested, showing its adverse impacts on research and development, and job creation in the health and science industries. The current moratorium on the tax is extended to January, 2020The letter, addressed to Sen. Mitch McConnell (R-KY), Senate Majority Leader; Sen. Chuck Schumer (D-NY), Senate Minority Leader; Rep. Nancy Pelosi (D-CA 12th District), Speaker of the House; and Rep. Kevin McCarthy (R-CA 24th District), House Minority Leader, says the tax suspension has “resulted in improvements in the ecosystem in the short term and has enabled companies to reinvest in R&D, make new hires, and provide new benefits to their employees like company-wide raises and increased 401(k) matches.”  
  • FDA issues new draft guidance on STeP and invites public comment:  The federal Food and Drug Administration issued draft guidance for a new voluntary pathway that aims to improve the safety of available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible for the agency’s Breakthrough Device Program.  The Safer Technologies Program, “STeP,” offers a pathway with similar benefits to the ‘Breakthrough’ program, including priority review and increased communications with FDA staff during development. STeP will cover devices and device-led combination products which are in the pre-market approval, de novo or 510(k) clearance processes. The deadline to submit comments is Nov. 18, 2019. More info is here.

*Don’t have their contact info handy? Send an email request to us at news@oregonbio.org and we’ll get that for you. 

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