Medical Devices Law & Industry Report provides complete in-depth, interdisciplinary news coverage of all major developments in the rapidly changing medical...
By Nathaniel Weixel
Consumer advocates told a House panel Feb. 15 that stronger medical device safety oversight is needed, especially now that the Food and Drug Administration has a potential new user fee agreement with industry.
At the same time, however, industry representatives and the head of FDA's medical devices division cautioned against broad congressional mandates that could take away FDA resources.
Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, told the House Energy and Commerce Health Subcommittee that FDA regulations are not hurting innovation, and that although the agency has met most of its goals regarding speed of device approvals, more can be done.
“We are not happy, industry is not happy,” Shuren said at the hearing. He said the agency needs more staff, citing a turnover rate over 8 percent. Shuren said increased funding from user fees would help the agency hire more full-time reviewers.
Shuren challenged the notion that FDA regulations are too onerous, saying that the agency's performance on reviewing device applications has been consistently strong. In testimony, Shuren said that 90 percent of all reviews of devices cleared through the 510(k) program—the method through which most devices reach the market—were completed in 90 days or less.
FDA and industry Feb. 1 reached a tentative agreement on proposed recommendations for the user fee program (6 MELR 83, 2/8/12). Shuren said the user fee agreement agreed to in principle by FDA and industry would help the agency meet new performance goals and make the approval process more predictable and transparent. Industry officials said the agreement is an important step in the right direction, and it builds a foundation for future agency success.
The user fee recommendations would authorize FDA to collect $595 million in user fees over five years, plus adjustments for inflation, which would double the amount of fees collected the last time the program was reauthorized. FDA collected more than $133 million from medical device companies during the first five years of the program (fiscal years 2003 through 2007). For fiscal years 2008-2012, Congress reauthorized a total of $287 million in device user fees over five years.
The final recommendations on the user fees were due to Congress by Jan. 15. Shuren told lawmakers during the hearing that once the final details of the agreement are completed, the agency will develop a package of proposed recommendations and give the public an opportunity to comment before they are submitted to Congress. The date of a public meeting has yet to be determined, but the agency hopes to submit the final proposal by mid-March, Shuren said.
Subcommittee Chairman Joseph R. Pitts (R-Pa.) called on FDA and the administration to expedite their review of the agreements, since the statutory deadline to submit them to Congress has passed.
“What is best for patients—and what is best for jobs—is to have a device review process that is clear, transparent, predictable, and accountable. I hope that is what the proposed agreement accomplishes,” Pitts said.
Consumer advocates, though, said the agreement does not do enough to guarantee patient safety. Lisa Swirsky, senior health policy analyst for Consumers Union, said the user fee agreement fails to make any patient safety improvements and falls short of providing the resources needed to meet increasing demands on the agency.
Swirsky said FDA had previously indicated that it needed between $770 million and $1.15 billion to implement the performance goals pushed by industry. Instead, the medical device industry has agreed to $595 million in user fees.
“The fees paid by medical device makers are currently so modest that even doubling of the fees is a small price to pay when considering that these devices may make companies millions to billions of dollars,” Swirsky told the panel.
Swirsky said the main point of contention between FDA and industry during user fee negotiation was review times, not safety.
“At a time when the device industry has seen large-scale safety failures of some of its products, such as surgical mesh and metal-on-metal hips, it is troubling that the main focus of conversations between industry and the agency that regulates it is on speeding up review times,” she said. “There is no mention in the agreement that these time goals are conditioned on the overall quality of the products, the complexity of the products, the benefit of the product to consumers, or any other factors that may be relevant to protecting the public health.”
In a report released at the hearing, Public Citizen noted that “as the FDA worked on its recommendations for [medical device user fees] revision in the fall of 2011, members of Congress—under heavy influence from medical device lobbyists—introduced several bills aimed at greasing the pathway for devices to reach the market.”
The group said the bills would “further reduce already weak standards for clearing and approving medical devices; shift the emphasis of the FDA's mission from protecting public health to promoting medical innovation; weaken the conflict of interest prohibition for serving on the FDA advisory committee that oversees device approvals; expand third-party companies that can review a device application to include those with significant financial relationships with the device industry; and more.”
David Perez, president and chief executive officer of manufacturer Terumo BCT and board member of industry group Advanced Medical Technology Association (AdvaMed), said predictability and transparency of FDA decisionmaking needs improvement, and the agreement will help the agency make meaningful changes.
“While we are making progress in improving patient care and see immense future opportunities to provide jobs and contribute to long-term economic growth, we are also worried,” Perez said. However, he said, the user fee agreement “is a huge step in the right direction. It is good for industry. It is good for FDA. And most of all, it is good for patients.”
Stephen J. Ubl, president and chief executive officer of AdvaMed, said in a statement that “the agreement has the potential to be a game-changer because of its series of strong, measurable performance goals that will bring much-needed improvements to the efficiency and consistency of FDA's medical device review process. It also provides FDA the resources it needs to meet the new goals.”
Ubl said the agreement “will require consistent and efficient administration by FDA leadership, as well as appropriate congressional oversight. We believe it is in the interests of patients and the American economy that this agreement functions well, and we will work with FDA to help make that happen.”
More information is at http://energycommerce.house.gov/hearings/hearingdetail.aspx?NewsID=9196.
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