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Public FDA Meeting Tackles 510(k) Review Process

As part of the ongoing saga of the U.S. Food and Drug Administration’s (FDA) 510(k) medical device clearance program, a public meeting was held recently to discuss the state of the agency’s embattled review process.

The day-long meeting on Feb. 18 in Gaithersburg, Md., just outside of Washington, D.C., may not have produced any epiphanic moments, but it did provide numerous stakeholders—FDA officials, lawmakers, device company executives, industry professionals, consultants and other interested parties—the opportunity to discuss strengths and weaknesses of the process and possible changes being considered. The 510(k) path is the means by which most medical devices in the United States reach the market.

Agency officials said the meeting would help inform an internal task force charged with highlighting changes the agency can make with existing powers. An outside report from the Institute of Medicine, due in March next year, will focus more broadly on the FDA’s device division and what additional power or changes it needs.

The 510(k) program often is incorrectly described a “fast-track” process because it relies on previous approvals of similar or “predicate” devices. A device applying for 510(k) clearance must show “substantial equivalence” to a device already given the OK by the agency (compared to higher classes of devices or novel technology that must undergo the more rigorous premarket approval process, which often required years of research and clinical data). Ostensibly, devices that undergo 510(k) review aren’t as high-risk, though critics claim some such devices have fallen through the bureaucratic cracks—a report issued by the Government Accountability Office last year highlighted some of higher-risk devices approved by 510(k). High-risk devices tend to be ones that are implanted in the body or that are life-sustaining. Only 8-10 percent of 510(k) submissions have required patient data, according to the agency.

About 3,500 devices are cleared every year under the 510(k) system. Meanwhile, about 50 devices are approved each year under the more stringent PMA system. Supporters of the 510(k) program say the review process is thorough and scientifically sound, while detractors claim the process isn’t as rigorous as it could be. All parties seem to agree, however, that some sort of review of the program certainly couldn’t hurt.

According to Donna-Bea Tillman, Ph.D., director of the FDA’s Office of Device Evaluation in the Center for Devices and Radiological Health (CDRH), the regulatory process must keep pace with evolutionary changes to medical devices.

“As science evolves, our regulatory approach also needs to evolve,” she said at the meeting. “We need to be continually assessing the regulatory framework for the review of medical devices to ensure that it is still accomplishing our fundamental mission to promote and protect public health.”

Heather Rosecrans, director of the 510(k) staff at the CDRH, highlighted the importance of ensuring that device regulations are clear and consistent.

“Developing clear definitions, guidance and additional authorities may be required,” Rosecrans said. “Utilizing rational application of guiding principles is vital.”

Though the FDA defended its current review process, the agency acknowledged that it faces difficulties in reviewing certain medical devices, hurdles that may call for additional regulations and authorities. Often, according to agency officials, it can be difficult to tell if a new device is truly similar to an approved product or if there are enough differences to classify it as an entirely new product, particularly given the pace of innovation in the medical device sector. Difficulty inspecting device makers and a high number of proposed new products are other issues to be considered,
according to FDA staff.

Device companies, industry consultants and investors said some smaller changes could improve the current process. They cautioned, however, that a major overhaul could stifle innovation and prevent newer technologies from reaching patients and doctors. Firms also are worried that they could see longer review times, higher costs and other hurdles that may make it harder to get their products on the U.S. market. The threat of greater regulation affects smaller manufacturers as well as larger ones—though smaller companies could be at a greater disadvantage. Companies could be asked to submit more data to win approval, requiring more research and development spending.

Some critics argued that an examination of the review process also is necessary to determine links to product recalls. FDA staff said most devices are recalled because of manufacturing or design problems, and that most likely would not change even if the agency implemented changes to the approval process. The FDA could issue more guidelines for companies to follow and focus more on staff training, other industry experts said.

Officials at the Advanced Medical Technology Association (AdvaMed), the industry’s largest trade group, said the 510(k) process is “already robust” and provides “strong protections” to American patients and promotes medical innovation.

“[The 510(k) program] gives FDA the flexibility it needs to ensure the safety and effectiveness of incremental changes made to low- and moderate-risk medical devices whose risks are well-understood from experience with similar devices,” according to AdvaMed officials. “It is important for patients to know that devices cleared via the 510(k) process undergo thorough FDA review. It has erroneously been called a fast-track process by too many in the media. That is an inaccurate characterization. The length of review is determined by FDA and based on potential impact to public health and on technological complexity. It is also important to note that FDA has total authority under the 510(k) process to require whatever evidence is necessary to assure a product’s safety and effectiveness, including clinical data when it deems this data to be necessary to assess the risks and benefits of a product.”

Kelly Slone, director of federal life science policy for the National Venture Capital Association based in Arlington, Va., said changes to the system could endanger innovation driven by small startup firms.

“These young companies, as years go on, get more fragile and harder to raise money and invest even though they have great ideas,” Slone said. “A critical part of the innovation ecosystem is at risk. VCs, when looking at innovative technologies, have to make a judgment on risk assessment to invest in novel technologies. We believe 510(k) is workable, but over three years there’s been a disturbing trend on impeding innovation. Why is this happening? We believe it’s because a burdensome regulatory environment has greatly reduced innovation.”

Not just a matter of consideration for industry insiders, the 510(k) program also has garnered attention on Capitol Hill. On Feb. 16, Sen. Charles Grassley (R-Iowa) sent a letter to the FDA asking for an update on its plans to issue new 510(k) guidelines.

“Over a year ago, I wrote to the FDA regarding serious allegations that an annuloplasty ring used in heart valve repair was being implanted in patients even though the device was allegedly not cleared for marketing by the FDA. The FDA concluded that the company had made the wrong decision when it marketed the product without first seeking clearance from the agency,” Grassley wrote. “That device has since been cleared by the FDA, but as I stated in my letter to the FDA last April, the fact remains that for more than two years, patients … were being implanted with the device before a 510(k) was submitted to the agency.”

Grassley wants a response from the FDA by early this month, answering questions about how and when manufacturers are required to update their device listings with the agency, how patients and doctors can “obtain information about the status of a device other than from the manufacturer itself” and whether manufacturers must update their listings if device names are changed without modifications to the product, or if modifications are made that don’t require a new 510(k) application.

After the meeting, Jeffrey Shuren, the new head of CDRH, said the agency could make some changes before the Institute of Medicine releases its report next year. FDA officials have said they will accept public comments for the next month before making its task force’s recommendations public in June. Any substantial new FDA authority over devices, however, would require action by Congress.

In related news, according to an FDA memo leaked to The Wall Street Journal, the agency is concerned about the use of third-party contractors hired by device makers to review products before a 510(k) application.

“If the third party signs off on the device, the FDA may approve it without much further scrutiny,” the newspaper reported. The memo indicated that third-party review may be perceived by the industry as a way to “sneak things in,” according to the Journal.

Third-party reviewers “often just repeat what is in the submission” without further scrutiny, according to the leaked memo, which could lead to the FDA limiting the devices it allows to be reviewed by outside contractors. Approximately 300 applications were reviewed by third parties during fiscal 2008, up nearly 63 percent since 2003, the paper said.

FDA & NIH Cooperate to Speed Device Innovation

Despite the recent wrangling over medical device review and claims that additional oversight would slow new device progress, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have kicked off an initiative to accelerate the development of innovative medical technologies.

According to the agencies, the joint program involves translational science, “the shaping of basic scientific discoveries into treatments,” and regulatory science, or “the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality,” according to a press release.

A joint NIH-FDA Leadership Council will be created to ensure that regulatory considerations form an integral component of biomedical research planning, and that the latest science is integrated into the regulatory review process, according to the release.

“We’ve all been following the remarkable advances in biomedical sciences led by the NIH with great enthusiasm for years,” said U.S. Department of Health and Human Services Secretary Kathleen Sebelius. “However, much more can be done to speed the progress from new scientific discoveries to treatments for patients. Collaboration between NIH and FDA, including support for regulatory science, will go a long way towards fostering access to the safest and most effective therapies for the American people.”

The program will provide $6.75 million over three years for regulatory science research on new methods, models or technologies for evaluating safety and efficacy in medical product development. A public meeting will be held this spring to gather input on how the federal watchdog and the national research organization can best work together.

Not So Fast: Device Tax Hasn’t Gone Away Just Yet

Just when medical device makers thought it was safe to go back in the water, a 10-year, $20 billion tax on medical device makers would begin in 2013 under a new healthcare reform proposal released by the White House in late February.

The election of Sen. Scott Brown (R-Mass.) following the death of longtime Democratic Sen. Ted Kennedy ended the Democrats’ filibuster-proof 60-seat majority in the Senate. Many industry insiders believed the multi-billion-dollar device tax also would disappear just like Democrats’ super majority, along with hopes for a speedy passage of reform legislation. In fact, the industry spent more than $20 million lobbying Congress during the fourth quarter of 2009, in an effort to make sure lawmakers understood the industry’s concerns.

The most recent legislative proposal for overhauling the healthcare system, released by the Obama administration, included the same 10-year, $20 billion tax on the medical device industry that was included in earlier healthcare reform bills. The excise tax, which would be administered by the Internal Revenue Service, will not be implemented until 2013, according to the 11-page proposal. The rollout deadline is a change from the healthcare reform bill passed by the Senate on Christmas Eve last year, which had the approximately $2 billion-per-year tax on the industry beginning in 2011.

Another idea that had been floated in previous versions of legislation would have exempted companies with less than $100 million in annual sales and would have required those reporting between $100 million and $150 million pay an excise tax on 50 percent of their revenues; the rate for companies with more than $150 million in annual sales would have been 100 percent. The new plan released by the White House did not detail how company revenue would play a role in the percentage of tax paid by individual firms.

Democratic lawmakers have a tough road ahead to revive the stalled legislation, a process that would involve intricate parliamentary maneuvering and carries no guarantee of success. But Obama indicated that if meaningful Republican cooperation does not materialize in the weeks ahead, he is ready to proceed without bipartisan support and risk the political consequences.

“The question that I’m going to ask myself and I ask of all of you is, is there enough serious effort that in a month’s time or a few weeks’ time or six weeks’ time we could actually resolve something?” Obama said following a recent White House healthcare summit that included representatives from both parties in the House and Senate. “And if we can’t, then I think we’ve got to go ahead and make some decisions, and then that’s what elections are for.”

The White House proposal is expected cost taxpayers roughly $950 billion over 10 years.

Boston Scientific Announces Layoffs and Outlines Management Shuffle

Ray Elliot, CEO of Boston Scientific, has said that 2010 will be a “rebuilding year” for the Natick, Mass.-based firm. He’s right, if the company’s most recent moves are any indication. The $8 billion device firm has announced plans to lay off between 1,000 and 1,300 workers, or 8-10 percent of its “non-direct labor force,” which means non-manufacturing jobs. The workforce reduction will help Boston Scientific save as much as $250 million in the next two years.

The layoffs are only one part of a larger restructuring plan that will see dramatic changes to corporate structure and management, in addition to a program of divestitures and acquisitions designed to “further rationalize and refocus its business portfolio,” according to company officials. The announcement comes shortly after the company released positive financial results.

As part of the restructuring the Cardiovascular Group and Cardiac Rhythm Management Group (formerly Guidant) will be combined into a single unit called Cardiology, Rhythm and Vascular, which the company claims will be “stronger and more competitive.” It will be led by Hank Kucheman, executive vice president and president of the new division. He previously served as head of the Cardiovascular Group. The Endovascular Unit, including Peripheral Solutions, Neurovascular, Imaging, Electrophysiology and the Canadian business unit, will report to new Senior Vice President Joe Fitzgerald. Fred Colen was promoted to executive vice president and chief technology Officer. Colen most recently served as president of Cardiac Rhythm Management.

Thecompany’s international headquarters will be eliminated.The firm’s presidents of Japan, Europe (and the newly formed Emerging Markets Group will report directly to the CEO. The Emerging Markets Group, composed primarily of India, China, Brazil, Russia, Eastern Europe and parts of the Middle East, Asia and Latin America, will attract greater investment and infrastructure, including the pursuit of selective offshore manufacturing, research, a variety of support services and individual country growth vehicles, officials said.Leadership for the division will be announced at a later date.

The Endoscopy division and new Urology and Women’s Health division each will report directly to the Elliot, and the Endosurgery Group structure, which currently oversees the Endoscopy and Urology/Gynecology divisions, will no longer exist. The newly named Urology and Women’s Health division will be led by new Senior Vice President John Pedersen. The Endoscopy division, led by new Senior Vice President Michael Phalen, will pursue incremental growth through devices for endoluminal surgery, obesity/diabetes solutions and pulmonary asthma. Steve Moreci, currently the Endosurgery Group president, will lead a newly created team devoted to global sales, including the company’s corporate sales group.

In addition, other management changes were made.

Sam Leno will be promoted to executive vice president and chief operations officer. He will oversee Finance, Information Systems, Manufacturing and Operations.Jeff Capello will be promoted to executive vice president and chief financial officer. Tim Pratt has been promoted to executive vice president and chief administrative officer; he will continue to serve as general counsel and secretary.The Company will consolidate Legal, Corporate Communications, Government Affairs, Human Resources, Quality and Regulatory Affairs under Pratt.

Jean Lance has been promoted to senior vice president and chief compliance officer and will become a member of the company’s Executive Committee. Lance joined Boston Scientific in 1996 and was named chief compliance officer last year. Prior to that she served as vice president and general counsel for the Cardiovascular Group.

Dan Brennan has been promoted to senior vice president and corporate controller. Larry Neumann has been promoted to senior vice president of Restructuring and Integration, which will include the combination of the Cardiovascular Group and the Cardiac Rhythm Management Group. Neumann has served in a number of capacities, including head of Corporate Tax, Business Development and Investor Relations.

Andy Milani was named senior vice president of Human Resources. Milani joined Boston Scientific last year after a career as an officer in the U.S. Army, serving most recently as chief of staff for the Army’s Special Operations Command.