An Era of Change: New ­Director, New ­Direction for FDA?

color:black;letter-spacing:-.05pt">Jeffrey Shuren, who has been the acting chief of CDRH since the departure of Daniel Schultz, is now officially director of the device unit. On February 1, FDA also announced that it had requested $4.03 billion for several initiatives, including to “invest in medical product safety.” The FY 2011 request represents a 23% increase over the FY 2010 budget. More than $100 million is earmarked for the Protecting Patients Initiative, part of which “will strengthen FDA’s ability to act as a strong and smart regulator to address medical product safety challenges in the years ahead.”

According to FDA, the proposed budget includes support for the FDA’s investment in addressing the challenges of the 21stcentury. Among other initiatives, FDA envisions increased efforts to address medical product safety challenges and a focus on modernizing regulatory science at FDA.

Since his appointment to acting director, Shuren has begun a comprehensive review of many programs and processes and set in motion a strategic planning process. He also prioritized the support of innovation in medical devices, the modernizing of device safety efforts, and the strengthening of important internal procedures.

“On the whole, the choice of Jeff Shuren to head up CDRH is promising,” says Jeffrey K. Shapiro, an attorney with Hyman, Phelps & McNamara. “He is a board-certified neurologist and has a law degree, which is very beneficial at an agency like FDA that regulates medical technology within a law enforcement framework.” Shapiro points to Shuren’s experience in dealing with policy issues at FDA as associate commissioner for policy and planning as solid background for the job.

But, he also notes that the proof will be in the pudding, so to speak. “His stated support for innovation is welcome, but we need to see how the agency moves forward in deeds, not words,” says Shapiro.

For one thing, it will be interesting to see how Shuren and his team at CDRH allocate the funds set aside for improving safety. “From an industry perspective, rather than resulting in tighter regulations, the $100 million FDA budget request for medical product safety will instead translate into more audits and more FDA resources focused on monitoring device companies’ quality operations,” says Tim Mohn, industry principal for Sparta Systems. “More specifically, FDA is investing in technology to allow better tracking and trending of problems without sending investigators on site. This includes the recently announced eMDR legislation that requires companies to submit adverse-event reports electronically to CDRH.” Mohn says that it is in device companies’ best interest to recognize that FDA will evaluate their data in ways that weren’t possible previously. He suggests that companies reevaluate their processes and systems to ensure that they are effectively monitoring their devices.

Industry will certainly need to pay attention to every move CDRH makes. Both AdvaMed and MDMA have issued statements supporting the selection of Shuren as director, but emphasize that FDA’s new direction must also consider the impact on innovation. “Smaller companies are responsible for the majority of innovation in the medical technology arena, and we look forward to working on policies that foster innovation,” says Mark Leahey, MDMA president and CEO. Likewise, ­AdvaMed acknowledged Shuren’s role as one of the key negotiators during the reauthorization of the Medical Device User Fee Act, noting that it demonstrated that he understands the unique needs of the medical technology industry. The industry organization says that Shuren has laid out a well-defined series of goals for the device center and a clear path for achieving his objectives in areas such as regulatory approvals.

FDA has scheduled a public meeting on Feb. 18 to discuss key challenges related to the 510(k) process. A major issue for industry is whether increased regulatory oversight will have adverse effects.

“My concern is that the agency is moving toward increasing the regulatory hurdles in premarket review that will hurt innovation,” says Shapiro. “It is unclear right now whether Dr. Shuren will be able to move CDRH in a different direction. Time will tell.”

Sherrie Conroy for the Editors