House and Senate Introduce Bills to Improve Medical Device Approvals

U.S. Sens. Amy Klobuchar (D-Minn.), Richard Burr (R-N.C.) and Michael Bennet (D-Colo.) introduced legislation intended to help boost medical innovation by reducing regulatory burdens that could delay new medical products from getting to market.

According to the Senate lawmakers, “The Medical Device Regulatory Improvement Act” would help streamline the U.S. Food and Drug Administration’s (FDA) regulation of medical devices to continue to spur innovation and help get new, life-saving products to the market quicker without compromising consumer safety. The senators are no strangers to device-related issues. Klobuchar founded the bipartisan Senate Medical Technology Caucus to increase awareness about issues facing the industry. Bennet, a member of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to FDA Commissioner Margaret Hamburg in August pushing for reformed FDA regulations that foster innovation and competitiveness as well as position the FDA to serve as a driver of the global economy. Following the letter, Hamburg joined Bennet to hear about innovation and advances in the bioscience industry in Colorado while touring the Colorado Science and Technology Park.

“It is critical that we don’t allow regulatory burdens to get in the way of delivering life-saving products to the patients who need them,” Klobuchar said. “This legislation will help ensure that we have processes that promote safe, pioneering technologies that help save lives and create good jobs in Minnesota.”

Burr said it’s time to “fix what’s broken” at the FDA.

“By streamlining and ensuring the least burdensome approach to FDA’s regulation of medical devices, we not only take a key step toward restoring America’s leadership in the research and development of lifesaving products, but uphold our promise to patients in North Carolina and around our nation to continue innovating on their behalf.”

Bennet said making the medical device review process clear and predictable is the name of the game.

“Colorado is a hub of the life-science industry and innovation, and we need to work with the FDA to ensure that it modernizes its regulatory system to foster innovation and drive the economy,” he said. “This bill would help provide our nation’s medical device developers and manufacturers with the regulatory clarity and predictability that would give our patients the greatest access to lifesaving products and boost our national economic competitiveness.”

The medical device industry has been particularly vocal about slower review times from the FDA’s Center for Devices and Radiological Health (CDRH), less predictability in the process, inconsistencies, longer review times and staff turnover. Recent studies showed that the average time to approve a 510(k) application has increased 43 percent between 2007 to 2010, and the average time to approve a premarket approval (PMA) application has increased 75 percent. A recent survey of venture capitalist life-sciences investors showed that almost 40 percent of investors are more likely to shift their operations and investments overseas because of FDA’s regulatory challenges.

The senators claim the legislation would help streamline the FDA’s device regulation by clarifying the agency’s current least burdensome requirements, ensuring that when making regulatory decisions on medical devices, “FDA focuses only on the relevant information during the decision-making process, considers appropriate alternatives to reduce the time, effort, and cost of reaching regulatory decisions, and uses all reasonable mechanisms to reduce review times when making these decisions.” The proposal also would direct the FDA to contract with an outside entity to conduct a thorough review of the management and regulatory processes CDRH, including the impact on medical device innovation.

Perhaps most notably, the measure would reverse 2007 legislation that barred experts who had financial ties to a company or its competitor from serving on an advisory panel without a waiver. There is also a limit on the number of waivers that keeps decreasing.

A senior official from the FDA’s drug office testified at a Capitol Hill hearing in August that the agency was having difficulty in recruiting highly qualified people for its advisory panels. The legislation also comes as medical device makers such as have criticized the FDA for strangling innovation with inconsistent regulation and lagging device approvals.

“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,” according to a statement issued by the senators.

The debate over the way medical devices reach the market has heightened in the wake of a July report by the Institute of Medicine (IOM) that concluded that the FDA’s 510(k) process “lacks the legal basis to be a reliable pre-market screen for the safety and effectiveness of moderate-risk devices.”

Since the IOM’s report, the medical device industry has pushed aggressively for an approval process that gets devices to market without prior testing, so long as they are similar to products that have already been approved. The industry maintains that many delays are not related to safety, but the result of extraneous bureaucracy. In response, the FDA has continues to release new process guidance and has enacted a series of internal changes to improve the process, all the while inviting industry and public comment.

The FDA did not return calls for comment on the legislation.

This wont’ be the only such bill to be introduced on Capitol Hill. On the other side of the capitol building, Republican Rep. Erik Paulsen (Minn.) is preparing his own bill, which should be released soon.

Response was swift from the industry’s largest association.

“AdvaMed applauds Sen. Klobuchar, along with her cosponsors Sen. Burr and Sen. Bennet, for their bipartisan work on this important legislation that will help American patients to get timely access to lifesaving, life-changing medical technology,” said Stephen Ubl, president and CEO of AdvaMed. “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 committees.”

But the proposal from the Senate side isn’t the only game in town. From the other side of the capitol, a proposal also was introduced in the House of Representatives.

Similar legislation called “Saving American Jobs and Saving American Patients” also aims to reform the FDA device review process. It was introduced by Erik Paulsen (R-Minn.), along with Reps. John Shimkus (R-Ill.), Brian Bilbray (R-Calif.), Cathy McMorris Rodgers (R-Wash.), Charles Bass (R-N.H.), Michael C. Burgess (R-Texas), Mike Rogers (R-Mich.) and Brett Guthrie (R-Ky.).