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Posts Tagged ‘PMA Procedure’

Will the Medical Device Regulatory Improvement Act Be a Game-Changer?

Monday, October 24th, 2011

Mark Crawford

Three years ago the FDA enacted tougher measures to reduce the potential conflicts of interest for medical device experts advising the U.S. Food and Drug Administration (FDA).

Claiming that these rules are strangling the timely advance of new medical devices to the market, U.S. Senators Amy Klobuchar (D-Minnesota), Richard Burr (R-North Carolina), and Michael Bennet (D-Colorado) have introduced the “Medical Device Regulatory Improvement Act” in an effort to streamline the FDA regulatory process.

Their hope is to reverse the 2007 law that bans experts with financial ties to companies from serving on advisory panels without a waiver. Currently individuals are barred if they have potentially conflicting financial interests exceeding $50,000.

“Because current conflicts of interest restrictions are overly stringent, the FDA is having difficulty finding qualified experts to serve on advisory committees, which can contribute to unnecessary delays for patients,” the senators said in a joint statement. “In response to this problem, the legislation would restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government. Finally, the legislation would also direct the FDA to contract with an outside entity to conduct a thorough review of the management and regulatory processes at the FDA’s Center for Devices and Radiological Health, including the impact on medical device innovation.”

They also indicate recent studies have shown “the average time to approve a 510(k) application has increased 43% from the 2003-2007 period to 2010, and the average time to approve a premarket approval (PMA) application has increased 75%. A recent survey of venture capitalist life sciences investors showed that almost 40% of investors are more likely to shift their operations and investments overseas because of FDA’s regulatory challenges.”
Their proposed legislation comes shortly after the FDA informed Congress that it was having a hard time finding qualified experts without financial ties to drug or device makers.

Consumer advocacy groups are fearful that, if the law passes, approval decisions will be swayed by the personal profit motives of panel members, rather than device safety motives. Opponents say the FDA is being pressured by the medical device and pharmaceutical industries and the agency isn’t trying hard enough to find unconflicted experts for panels.

“For instance, we wrote two months ago that the Project on Government Oversight (POGO) watchdog group challenged the FDA to look harder for qualified panel members and cited data gathered by the agency to debunk recent comments made by agency officials,” says Ed Silverman in his blog at www.pharmalot.com. “POGO found the number of conflict of interest waivers granted for FDA panel members never exceeded 5 percent, below the legal cap of 13 percent.”

Silverman also reports POGO learned the “vacancy rate for advisory committees fell another 2 percent this year, and has fallen 10 percent overall, from 33 percent in 2009 to the present rate of 23 percent, suggesting the FDA is having fewer problems finding experts without industry ties.”

Klobuchar stresses that her proposed legislation will focus on eliminating inefficiencies, not health and safety standards. For example, the FDA has not adopted the Institute of Medicine’s suggestions to streamline or possibly replace the current approval process, choosing instead to do more studies.
“It is critical that we don’t allow regulatory burdens to get in the way of delivering lifesaving products to the patients who need them,” says Klobuchar, “We might have one response from a consumer group . . . but the patient groups for certain diseases who have been waiting years to get a change approved for a device that’s already approved in Europe feel differently about this.”

AdvaMed, a medical device trade association, fully supports the proposed bill and believes it will help get life-saving technology to patients faster.
“We are especially encouraged to see the legislation’s focus on clarifying FDA data requirements, streamlining agency management processes, and its emphasis on the importance of attracting the best experts to FDA advisory committee,” says AdvaMed president Stephen Ubl.


FDA Wants Four-Star Reviews

Wednesday, August 17th, 2011

Guest Blogger: Mark Crawford, Contributing Writer

The FDA is tired of being the rate-determining step when it comes to the medical device approval process. In the field of chemistry, the rate-determining step is the slowest step in a chemical reaction—the reaction cannot go faster than the rate-determining step. To speed up their game, the FDA recently announced its medical device reviewers will undergo more extensive training, starting in September 2011.

The medical device review process of the FDA’s Center for Devices and Radiological Health (CDRH) has been heavily criticized over the years for being cumbersome and slow. A major factor in these complaints, especially for 510(k) and Premarket Approval Application (PMA) procedures, is high FDA reviewer turnover.

When reviewers change, momentum and consistency are lost. Work is duplicated. New reviewers are often not experienced enough and ask the wrong questions. Sometimes the process has to be restarted from the beginning. This all slows down the approval for new devices, increases costs, and escalates frustration.

According to Dario A. Machleidt on the Frommer Lawrence & Haug “FDA Lawyers Blog,” reviewer turnover at the FDA’s CDRH division is 8.6 percent, or twice the rate of the FDA’s “sister drug and biologic arms.” Jeffrey Shuren, director of the CDRH, indicates that change is necessary to address this issue and that “[w]e need to find the means to handle the ever-increasing workload and reduce staff and manager turnover.”

“Shuren also stated ‘the majority of my reviewers have less than four years of experience [and that] [m]y front-line managers generally have three years experience or less,’” writes Machleidt.

To make matters worse, adds Machliedt, ratios of managers to reviewers range from 1 to 14 on the high side, to 1 to 27 at the lower end, “which results in a small number of managers, let alone experienced ones, to train and oversee inexperienced reviewers. Further, the negative impact of the CDRH’s high turnover is exacerbated by the fact that innovative medical technologies are becoming increasingly complex and therefore require longer review times even by experienced CDRH personnel.”

In a recent meeting with medical device manufacturers in Minnesota, Shuren announced FDA medical device reviewers will undergo certification and training beginning in September 2011. The goal of this first-of-its-kind program is reducing the frequent turnover of FDA reviewers and streamlining the medical device application process.
“Implicit in the FDA’s decision to implement the program is the hope that standardized training will reduce inconsistencies between individual reviewer decisions,” states Machleidt.

If resources and time permit, the FDA also wants its reviewers to get first-hand experience in the field “to see what goes on in the real world” (always a good thing!). As productive as this would be, however, it may be difficult to accomplish with a potential 12.5 percent reduction in the CDRH budget.

Whether all of this happens or not, it is always a step in the right direction when a large government agency like the FDA makes the effort to appease the concerns of the industries it regulates. Ideally the education will include the scientific training needed to handle the new medical innovations, as well as training on technology to better understand the tools being used to adhere to Part 820 for QSR inspections.

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