User Fee Legislation
In August 2017, Congress passed and the president signed the FDA Reauthorizaton Act (FDARA), to build on the successes of previous FDA user fee agreements and implement additional pro-innovation reforms. AdvaMed’s Government Affairs department worked hand-in-glove with the association’s Technology and Regulatory Affairs department to ensure swift passage of this pro-industry legislation.
Reauthorization of the FDA user fee agreement under FDARA includes more robust agency performance goals and process improvements to help speed product approvals. Additional provisions of the legislation call for improvements to the FDA inspections process, streamlined device accessory classification, and increased accountability. Altogether, these provisions aim to help make FDA a partner rather than a barrier to innovators creating life-changing technologies while also providing additional resources to help make it happen.
Veterans Affairs & Venture Capital Needs
During the year, AdvaMed advocacy on Capitol Hill was also instrumental in raising awareness and building the industry’s profile in support of veterans, and the venture capital needs of young companies. In August, AdvaMed organized a Capitol Hill roundtable with industry representatives and senior leadership of the Department of Veterans Affairs, focused on addressing inefficiencies in the VA procurement process. The event included House Veterans Affairs Committee Chairman Phil Roe (R-Tenn.), as well as committee members Jim Banks (R-Ind.) and Scott Peters (D-Calif.). To address VC funding challenges of small companies in particular, AdvaMed advocacy culminated in the October introduction in the House of angel investor tax credit legislation.
Device Tax Repeal
Throughout 2017, AdvaMed also continued a robust lobbying and public affairs campaign to repeal the innovation-crushing medical device tax. This included release of survey data showing the medtech industry poised for greater investment and growth with full device tax repeal, and data from the U.S. Department of Commerce showing the industry lost nearly 29,000 jobs while the tax was in effect. Organizing the industry behind a united message on the benefits of the 2016-2017 suspension of the tax and the need for permanent repeal, AdvaMed’s advocacy efforts were amplified through multiple Capitol Hill “fly-ins” with company CEOs and others, and echoed by allies and partners in the patient and research communities. As a result, repeal or extended delay of the tax was included in every health care reform bill brought up in the House and Senate during the year. In December, AdvaMed’s Board of Directors approved an expanded public affairs campaign to help drive these efforts across the finish line, including compelling TV ads, and print and digital ads targeting key members of Congress. This resulted in a two-year renewed suspension of the tax in January 2018. AdvaMed remains committed to building on this suspension to drive full repeal of the tax.