By Donna Mitchell-Magaldi, Nerac Analyst
The FDA faces a daunting task. If a device is not approved fast enough, it is accused of causing unnecessary deaths due to the delay. However, when the FDA approves a device and deaths result, it is accused of rushing through the approval process and not taking public safety seriously. The FDA’s request to reauthorize the Medical Device User Fee and Modernization Act (MDUFMA II) attempts to address faster approval times, but it might cause increased safety issues down the road.

Proposal Details Are Vague
MDUFMA II will expire Sept. 30, and the FDA wants Congress to reauthorize the act. The agency also wants Congress to adjust its fee structure for conducting reviews. The FDA is asking for a 31 percent overall increase in user fees next year and 8.5 percent increases each year after that through 2012. The estimated $287 million in fees collected during that five-year period would account for about 23 percent of the more than $1.2 billion FDA estimates it needs to adequately review medical devices. Taxpayers would pick up the rest of the tab.

But here’s where it gets confusing. Under the new proposal, application fees for new medical devices would be reduced. But the FDA proposes initiating additional fees, including registration fee based on the number of manufacturing facilities medical device companies register with the FDA. The proposal does not spell out how or if the FDA is going to ensure that medical device companies register an accurate representation of those facilities, which might include oversees facilities that could be difficult to track. Other fees include one for periodic reports and fees for additional types of applications.

Overall, the proposal is so vague on how the fees would be assessed and how much money they would generate that it is hard to understand how the FDA comes up with the 31 percent increase in user fee collections. The FDA’s math just doesn’t seem to add up.

The FDA is also proposing a third-party inspection program in which manufacturers with good compliance histories could select an FDA-accredited, non-government entity to perform quality systems inspections. It is anticipated that this program will increase inspections of device firms and permit the FDA to focus its inspection resources on companies and products’ with greater noncompliance issues.

Turn-Around Promises for Manufacturers
In exchange for the Device Manufacturers agreement, the FDA has promised a faster turn-around time on approval decisions. The FDA will reach a decision on 50 percent of expedited pre-market applications and expedited supplement applications within 180 days and 90 percent within 280 days. The FDA would reach a decision on 60 percent conventional pre-market applications and supplement applications within 180 days and 90 percent within 295 days. The FDA also promises a decision on 90 percent of 510K applications (lower risk devices) within 90 days and 98 percent within 150 days.

The FDA claims that because medical devices are becoming increasingly complex, there is a growing need to bolster the system that ensures safety of the products over the entire life cycle. The agency states that these “increased fees will allow the FDA to improve the ability to identify, analyze and act on post-market safety information by hiring additional staff to handle the product recalls and deploy analytical tools to detect adverse events in medical devices on the market.”

It’s a good thing that the FDA is allocating funding for post-market surveillance. Because it is proposing to speed up the review process by nearly 8 percent, post-market review will be that much more critical to limit patient risk. But by imposing these deadlines, scientists might be pressured to act in the best interest of device companies and not necessarily the public. Although it is important to make available life-saving technology to the patient population, there must be a balance between increasing speed-to-market and ensuring that such devices are safe.

Consumer advocacy groups, scientists, and former FDA employees harshly criticize the FDA, charging that the agency is in partnership with device companies rather than overseeing the industry as it was originally intended. The fact that the FDA negotiates user fees with medical device companies in return for faster approval times does nothing to dispel the accusations.

Is MDUFMA II Good For Medical Device Companies?
On the surface, this Act looks like a dream come true for the medical Device Manufacturers. However, in reality it is nothing less than a public relations nightmare.

Critics and consumer advocacy groups portray medical device and big pharmaceutical companies as having absolutely no ethics and in sole pursuit of increasing their bottom line. Safety and efficacy are not priorities, they claim, and pushing such devices through the FDA quicker is a way to ensure that manufacturers get the biggest bang for their buck.

They argue that the FDA is more a facilitator than a regulator of industry. Dr. Marcia Angell, former editor of the New England Journal of Medicine, suggests strengthening the FDA as an independent agency by cutting its ties with industry by allowing the user fee act to expire and replacing lost funds with more public support. Republican Sen. Mike Enzi of Wyoming agreed that Congress should re-examine the way it funds the FDA. He also expressed doubts that giving the agency more money would solve its problems.

Although the money collected by the FDA from medical device manufacturers would help fund its investigations, the controversial details of this act do nothing to portray medical device companies in a good light. In fact, this act only lends credence to the allegations expressed by medical devices companies’ harshest critics.

It is unclear how the new user fee schedule will improve turn-around times. That’s a matter of the FDA’s efficiency, not how much a medical device company pays for an application. It is just as hard to tell how a program allowing companies to choose FDA-accredited investigators will improve approval turn-around times. The agency’s intent would seem an attempt to sell the idea of user fees to make medical device companies feel as if they are getting something in return.

It might be better for the medical device community to consider distancing itself from FDA funding and allow the agency to return to a publicly funded entity. This way the FDA can be held more accountable to the public, and medical device community can divorce itself from the public relations problems created by being so closely aligned with the agency. By allowing this act to expire, the medical device community sends a strong message that it is not in partnership with the FDA and holds no influence over its performance. Just as studies funded by the affected industry often lack credibility, FDA assessments funded by medical device companies will always be suspect.