While pro-lifers are celebrating the appointment of one of their own to a key congressional subcommittee on health, medical device makers might want to pay close attention to Rep. Joe Pitts (R-Pa.) and what he thinks about the industry.
Pitts, who has represented rural eastern Pennsylvania since 1997, was named chair of the Health Subcommittee of the House Energy and Commerce Committee, where he has held a seat since 2001. The committee will likely be critical in several decisions that could greatly affect the medical device industry, as it has broad oversight over several regulatory bodies.
Aside from being a loud voice in opposition to abortion, abortion funding and the healthcare reform act, Pitts is no stranger to the medical device industry — he authored the Medical Device User Fee Stabilization Act of 2005, which eliminated a trigger in the original 2002 user fee act that would have terminated the program, which was reauthorized in 2008 by George W. Bush.
On Pitts’ web site, he hails the bill’s passage as saving “an important program at the Food & Drug Administration that helped manufacturers of life-saving devices avoid lengthy approval delays.”
Pitts was also one of 12 congressmen that sent a letter to FDA head Dr. Margaret Hamburg asking the agency for more transparency as it mulls changes to its 510(k) medical device clearance program.
In the letter, the leaders called five proposals in the 510(K) reform package”controversial,” including the agency’s stance on recession authority, split and multiple predicates, clarifying intended use and indications for use, mandatory pre-market inspections and mandatory clinical information for a subset of Class II devices.
“All have the potential to disrupt the review process,” they wrote.
With the user fee program’s reauthorization slated to come before the 112th Congress, Pitts’ thoughts on the program he helped continue will certainly be germane — and he probably won’t need to write any letters to make his voice heard.
“Free markets and ingenuity have produced amazing healthcare advances. We need to harness those same forces to make modern healthcare affordable,” he wrote in a press release announcing his chairmanship. “We need to repeal Obamacare and replace it with something better. We need to protect human life from the unborn to the elderly. We need federal agencies to empower American companies to compete and prosper.”
The congressman’s agenda, beyond trying to repeal the healthcare reform bill, is still unclear. Calls to his press office were not immediately returned.
But it’s clear that Pitts will be able to use his station to put the spotlight on the FDA, 510(K) reform and maybe even the question of whether the agency is living up to its end of the bargain when it comes to user fees.
“This Congress is going to have to the user fee bill, which is a magnet for other FDA policies,” Brett Loper, senior vice president and director of government affairs for AdvaMed, told MassDevice back in November. “I suspect next year the FDA will be called before the energy and commerce committee.”
Renewed scrutiny of the agency is a natural result of partisan politics, Loper added.
“When the same party is in charge of Congress and the executive branch, there’s usually much less oversight of what the agencies are doing,” he said. “Once you get different leadership, it creates some tension. Our view is [that that’s] generally good because it helps moderate things.”
Congress needs only the power to call agency heads in front of them in order to affect day-to-day operations, Loper noted.
“Legislating not the only tool they have to change what the agency is doing. Oversight can effect the way the agency is making decisions,” he explained. “A chairman looking at agency heads saying, ‘Why are you doing this?’ has an impact, because at the end of the day they’re responsible for implementing the law Congress told them to. You will see the energy and commerce committee more focused on what the FDA is doing, including 510(k), and that’s a healthy thing.”