MassMEDIC Delegation Holds Meeting with Sen. Warren: Device Tax and FDA Operations Focus of Discussion
Dear MassMEDIC Member:
On Friday, July 26 a delegation of MassMEDIC members visited Massachusetts Senator Elizabeth Warren in her Boston office. Joining us were: Heather Keith, Strohl Medical; Susan Lisa, Abiomed; Mike Phalen, Boston Scientific; Amar Sawhney, Ocular Therapeutix; and Sharon Starowicz, DePuy Spine.
During our hour-long meeting, we discussed a range of issues impacting the medical device industry. We were pleased to learn that she would continue to support efforts to repeal the medical device tax, if an appropriate offset could be found. She was also impressed with our presentations on how the tax is impacting MedTech companies of all sizes. We also discussed MedTech’s response to the shifting market changes brought on by the implementation of the Affordable Care Act. Sen. Warren was particularly interested in learning more about how FDA product clearance and approval operations are adversely impacting innovation, U.S. companies’ market dominance and corporate and job growth in the industry.
Senator Warren, a member of the Senate committee that oversees the FDA (Health, Education, Labor and Pensions), has asked MassMEDIC to develop a short list of actionable items for presentation to FDA leadership at a meeting in Massachusetts later this year. She pledged to broker such a meeting on industry’s behalf and has assigned staff to coordinate this effort.
MassMEDIC will soon convene a small working group of members to develop the list of priority issues that impact product clearance and approval. All members will be apprised of this panel’s work and your input will be essential to our success in conveying our concerns to the agency.