MDMA Annual Meeting In Brief
This article was originally published in The Gray Sheet
Executive Summary
User fee legislation revisited: "Everything is on the table" when it comes to negotiating user-fee legislation this year, Senate Health Committee staffer tells the Medical Device Manufacturers Association at its annual meeting in Washington, D.C. May 17. Chair Mike Enzi (R-Wyo.) acknowledges that Congress failed to appropriate sufficient funds to FDA in recent years, even though firms have paid higher fees each year under the Medical Device User Fee & Modernization Act, the staffer said. Therefore, a future legislative fix may involve ways to "right-size" the program. The committee expects to introduce amendments to MDUFMA before Labor Day....MDUFMA a deal-breaker?: Former MDMA Chair Paul Touhey, president of Fujirebio Diagnostics, affirmed his belief that MDUFMA "will get changed and adjusted pretty dramatically, because the large companies are now being affected by it. And I know that because I'm currently negotiating a deal in my company with a multi-billion dollar company and one of the sticking points of the deal [is] who's going to pay the user fee"...