Senators’ Letter Ties User Fee Reauthorization to FDA Change

The reauthorization of the U.S. Food and Drug Administration’s medical device user fee program is a year away, but lawmakers—a few anyway—are getting a head start.

Sens. Richard Burr (R-N.C.) and Tom Coburn, M.D., (R-Okla.) sent a letter dated June 13 to medical device, pharmaceutical and biotech industry lobbying organizations saying that the upcoming user fee negotiations are an “important opportunity to address the root causes of the threats to our nation’s leadership in medical innovation” in addition to advancing “common-sense solutions on behalf of patients.”

The senators wrote that they welcome proposals that streamline the drug and device approval process to ensure that patients receive timely access to the latest treatments and technology.

“Unfortunately, recent years have yielded a disturbing trend of policies and actions being advanced that we fear are eroding American leadership in medical innovation,” the senators wrote. “Sadly, the net effect of this erosion of American innovation is the delay or denial of life-saving, life-enhancing drugs and devices for patients. It is time to reverse this trend.”

The Medical Device User Fee and Modernization Act, commonly known in the industry by its acronym MDUFMA, expires in 2012.

Turning up the rhetoric, the lawmakers went on to write: “As you negotiate the next user fee agreement and prepare to submit the proposal to Congress, we wish to underscore the necessity of restoring regulatory certainty and predictability … Proposals that grow bureaucracy, strangle innovation with red tape, or further erode our nation’s standing as the world’s leader in medical innovation will not be well-received.”

The letter echoes industry’s latest war cry that the FDA and its device office, the Center for Devices and Radiological Health (CDRH), have bogged down the device review—particularly the 510(k) process, which the agency has been working to change over the past year with new processes, industry feedback and internal review—which costs the industry valuable time and money, making a difficult economic situation even harder.

During the recent annual meeting of the Medical Device Manufacturers Association (MDMA) in Washington, D.C., FDA Commissioner Margaret Hamburg, M.D., indicated that she and officials at CDRH are trying to help not hinder new technologies’ market access.

“Venture capital has been constrained and the investments that are being made come later in the product development cycle, leaving companies struggling to find resources to get devices from the workbench to the marketplace,” she said. “This is not good for individuals, our communities or our nation. I want to convey that I’m listening to you and that I hear your concerns. It is easy to forget that when issues get complicated, as they often do, that our missions are actually aligned.

Hamburg reiterated that the FDA plays a critical role in the industry’s ability to compete in a global marketplace.

“We understand the stakes of maintaining our potion as a global leader. We know medical device development is expensive and often quote risky. We know that consistency and predictability on our part would make your jobs easier. We’re continually working to enhance our systems to improve our premarket review program.”

Following Hamburg, CDRH Director Jeffrey Shuren told the gathering that 2010 was spent evaluating the changes that need to be made to the 510(k) program and that 2011 has been a period of implementation. Part of Shuren’s message to industry is that the change it wants will happen, but the agency needs time to put all the new processes in place. It’s not just about new guidance and process, Shuren explained, it’s also about changing the culture at CDRH—making it operate more like a business.

“This year is about action,” he said. “Making process, predictable and transparent.”

Shuren said CDRH is initiating a corrective and preventative action (CAPA) program to make it more responsive to industry’s needs.

“If we impose CAPA on you, we should abide by it too. If a problem comes up, we will be tracking it and look for trends. If we’re seeing an underlying problem, we need to identify it quickly and solve the problem,” he said.

He concluded by urging constant communication with CDRH. It’s not a new message from the FDA, but Shuren said a lack of communication or miscommunication has upped some of the vitriol that now seems common in the industry/agency relationship as of late.

“I need to hear from all of you. If you have a problem, you need to come talk to me or one of my senior managers,” he told the MDMA gathering. “Nobody is going to retaliate against you because you raised an issue … The increasingly adversarial environment that we’re in, particularly in Washington, is not helping at this point.”