New AdvaMed Chairman Nadim Yared is making the elimination of the 2.3% medical device excise tax his top priority.
The medical device lobbying group helped secure a two-year exemption that ends Dec. 31, 2017, and is now aiming to end the tax entirely. Those efforts were dealt a setback by the failure of the Republicans' healthcare reform legislation.
"No matter what, this will be the first priority that we look at any time we're examining a proposal on the table," Yared said during a March 30 conference call.
AdvaMed wants the tax repealed as soon as possible, said Yared, the president and CEO of CVRx Inc., the maker of an investigational implant to treat heart failure and high blood pressure.
He also called for passage of the medical device user fee agreement, which would provide $995 million in industry funding over five years to the agency's device center, which is led by Jeffrey Shuren.
"Dr. Shuren has been effectively steering the FDA over the last four or five years. We are starting to see the results. It's not the time to change course," Yared said.
AdvaMed is supporting passage of a bill to reform the FDA's medical device-inspection process, which it hopes to include as an add-on to the user fee agreement. Senior Executive Vice President Janet Trunzo said during the call that the proposed legislation supports the FDA's initiative to improve the quality of its inspectors through increased specialization in medical technology manufacturing, as opposed to the manufacturing of food and drugs.
Yared said a third priority is implementing the recently passed 21st Century Cures Act, which contains modest reforms to the regulation of medical technology. Follow-through on the law's provisions could be complicated by President Donald Trump's executive order to eliminate two old regulations for each new regulation that is created, according to the testimony of congressional representatives during a March 28 hearing featuring Shuren.
Yared, the first chairman of AdvaMed to head a startup medical technology company, called for the trade association to be "a convener" of various industry stakeholders, such as contract manufacturers, and said small medical technology companies face unique challenges, including the need to raise venture capital dollars.