Sen. John Kerry (D-Mass.) is making some moves to protect one of his major business constituencies in the Bay State.
The senior senator from Massachusetts will host a pair of meetings in Boston July 11 between FDA commissioner Dr. Margaret Hamburg, Center for Devices & Radiological Health chief Dr. Jeffrey Shuren and representatives from the Commonwealth’s medical device and biotechnology industries in an effort to open up a dialogue between the oversight bureau and two of the state’s most critical industries.
His goal “is to foster a direct conversation between two vital Massachusetts industries and the regulators that oversee them. I want to create an open dialogue and build a collaborative relationship for our companies and the federal government,” Kerry said in a prepared release.
The meetings come at a critical time for both industry and regulators, particularly for the device industry, which is in negotiations with the FDA over re-authorization of the medical device user fees that help pay for federal oversight of the sector. The fees are mandated by the Medical Device User Fee & Modernization Act, which is set to expire in 2012.
Register for the MassDevice Regional Roundtable on July 11 to hear from Dr. Jeffrey Shuren himself
In recent negotiations, the federal watchdog agency asked for a fee hike so that it can maintain its 2010 level of operation, which would amount to a roughly 17 percent increase. The FDA is also requesting more cash to add another 254 employees to its 1,230-person workforce. The gulf between the two parties appears to be the agency’s contention that the total workload for the FDA has increased.
For its part, the med-tech industry isn’t buying and maintains that workloads are static. The industry also contends that the FDA has essentially doubled user fees over the lifetime of the program and has not met the performance goals also established by MDUFMA. During an early June meeting, industry representatives proposed a two-year stay at current levels (adjusted for inflation), arguing that agency had “not yet achieved” some of the qualitative and quantitative goals set when the program was re-authorized in 2007.
FDA officials said the industry’s proposal would actually amount to an 11 percent cut in user fee resources for fiscal year 2013 and create “even greater uncertainty about long-term program stability which would exacerbate the turnover problem and reduce staff morale.”
“It does not address Congressional intent for a 5-year re-authorization, increases the cost of the re-authorization process, and creates uncertainty by de-linking MDUFMA re-authorization from [Prescription Drug User Fee Act] re-authorization,” they said.
Device industry reps disagreed, saying there’s “no support within the industry for the increase in fees” contained in the agency’s re-authorization plan.
In an unrelated note, Kerry lauded a Senate Finance Committee decision to strike a provision from its markup of the Trade Adjustment Assistance and three Free Trade Agreements that would have cut Medicare payments for medical imaging services by $400 million.
“Medical imaging accounts for more than 10,000 jobs in Massachusetts with even bigger spin-off contributions to our state’s economy,” Kerry said in prepared remarks.