Inside Look: MDMA to Target Regulatory Process

Next year, the association will also continue to fight the device tax.

November 29, 2011

2 Min Read
Inside Look: MDMA to Target Regulatory Process

For the final Inside Look of 2011, we're turning the spotlight on two of industry's biggest advocacy groups: AdvaMed and MDMA. Read on to get the scoop on MDMA, or learn more about how AdvaMed's year went.

November: Representative Erik Paulsen’s (R-MN) legislation to repeal the device tax has 225 cosponsors.September: President Barack Obama signs patent reform bill into law.March: Senators Scott Brown (R-MA) and Amy Klobuchar (D-MN) form Medical Technology Caucus in the Senate.

Mark Leahey, president and CEOEamonn P. Hobbs, chairman of the board of directorsAlexis Lukianov, treasurer of the board of directorsKelvyn H. Cullimore Jr., secretary of the board of directorsThomas Novelli, vice president of government relationsHeather Rosecrans, vice president of regulatory affairsBrendan Benner, vice president of public affairsSheri DeVinney, director of operations and executive assistant to the president

The Medical Device Manufacturer’s Association (MDMA) set lofty goals for itself in 2011. Its four-part agenda called for repealing the medical device excise tax, ensuring a reasonable and predictable regulatory pathway for devices and technologies, preserving intellectual property laws, and promoting timely and adequate reimbursement.

The device tax is still looming, but MDMA president and CEO Mark Leahey says bills calling for its repeal have been introduced in both the Senate and House. At deadline, at least 225 representatives had signed on as cosponsors.

Progress has been made in other areas, too, Leahey says. In September, Congress passed long-awaited patent reform legislation. “While the patent reform legislation that was signed into law is not perfect, MDMA was pleased that many of the onerous provisions that would harm medtech innovators were not in the final version,” Leahey says.

The association will continue to target many of the points on its 2011 agenda in the coming year. Leahey says priority No. 1 will be increasing predictability and transparency in the regulatory process. MDMA will also keep its crosshairs set on the device tax, set to go into effect in 2013.

“We continue to work passionately with Congress, FDA, and other parties to ensure that today’s medical technology innovators can deliver on the promises of tomorrow,” Leahey says.

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