Representatives Paulsen and Altmire Address MDMA

Originally set to speak to conference attendees during the welcoming reception, Congressman Erik Paulsen (R-Minn.) was tied up on the Hill working to pass the repeal of the medical device excise tax through the House committee on Ways and Means. It did, finally, on May 31, and Paulsen was able to deliver his much anticipated address to the Medical Device Manufacturers Association (MDMA) at its 2012 conference on Friday morning June 1. Congressman Jason Altmire (D-Pa.) addressed the assembly immediately afterward.

Paulsen began by commenting on the “momentous” passage of the U.S. Food and Drug Administration (FDA) user fee renewal legislation in the U.S. Senate and House of Representatives with overwhelming majorities.

Michael J. Daley, Ph.D., president of tiGenRx LLC, based in New Hope, Pa. asked Altmire why the amendment for repealing the device tax could not be included with the FDA bill. The bill, which reauthorizes the Prescription Drug User Fee Act (PDUFA), the popular program that charges drug companies fees that help fund the FDA’s drug approval programs, as well as the Medical Device User Fee Act (MDUFA), “went through with no amendments or controversy,” said Altmire. That is what supporters of the bill wanted—if amendments had been added, it would not have passed with the support that it did.

“The process is not over,” Paulsen said. He doesn’t want to see the same problems with the FDA repeating themselves years from now. He emphasized that neither industry players nor legislators should allow the FDA to “move the goal posts” set by the bill at any time.

Being from Minnesota, a major global medtech hub, it’s not surprising that Paulsen is at the forefront of pushing for the interests of the medical device industry in general and the repeal of the device tax specifically.

“I try very hard to put a human face on your industry,” he told the audience. “It’s really about engineers, doctors, entrepreneurs, trying to help patients. You create outstanding jobs, and are now under threat from our own government. Having a more transparent process is good.”

Altmire followed up that statement with commentary on how to get the attention of legislators on the Hill, who hear advocates from countless interest groups and industries every day: “The selling point for you in D.C. is to bring me a patient. Let me look them in the eye. Let me hear their story. That’s powerful and I won’t forget that—a constituent that I’m elected to represent.”

Paulsen called the device tax the “next opportunity” for the industry to make its voice heard. Both he and Altmire enthusiastically described the road they have been down gaining co-sponsors for the tax repeal bill. Every day they have been gaining more supporters (240 at the time of address) indicating that when the bill is voted on it should be successful. The tax was an “ill conceived idea,” said Paulsen, “an anchor that will bring the industry down.” He pointed out that the tax will be one of the highest industry taxes in the world, despite U.S. medical industry taxes already being pretty high.

“There are 2,700 pages in the healthcare bill,” Altmire said. “There are a lot of things we could be talking about, but this has risen to the highest profile. You’ve won the fight on the fairness issue—now we have to win in legislation.”

Though some legislators aggressively opposed to the Affordable Care Act (ACA) want to repeal the either whole thing or none of it, Paulsen said he has been able to convince them of the importance of repealing the device tax, which is, in his view, the most damaging part of the ACA. This view is most certainly a bipartisan view, one of its most notable supporters being the liberal Democratic candidate for Senate in Massachusetts, Elizabeth Warren. Paulsen commended his colleague Altmire as a “great partner” for this bipartisan cause, and expressed his regret that Altmire would not be returning to office next year.