Proposed Medical Device Legislation in the House and Senate Takes Aim at the FDA

A bicameral effort is underway to make the medical device review process more predictable for medical device manufacturers. New legislation introduced in the U.S. House of Representatives and U.S. Senate is intended to help boost medical innovation by reducing regulatory burdens that could delay new medical products from getting to market.

The first bill was introduced by Sens. Amy Klobuchar (D-Minn.), Richard Burr (R-N.C.) and Michael Bennet (D-Colo.).

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 nation’s medical device review process more “clear and predictable” would “boost national economic competitiveness.”

The medical device industry particularly has been vocal about slower review times from the FDA’s Center for Devices and Radiological Health (CDRH), less predictability in the process, inconsistencies, and staff turnover. Recent studies indicate the average time to approve a 510(k) application increased 43 percent between 2007 and 2010, and the average time to approve a premarket approval 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 at 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 also is 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 makershave 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 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.”

Following 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 thatalready have been approved. The industry maintains that many delays are not related to safety, but the result of extraneous bureaucracy. In response, the FDA has continued to release new process guidance and has enacted a series of internal changes to improve the product approval process, all the while inviting industry and public comment.

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

Response was swift from the industry’s largest trade group, the Advanced Medical Technology Association (AdvaMed).

“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 U.S. House of Representatives.

Similar legislation called “Saving American Jobs and Saving American Patients” aims to reform the FDA device review process. Introduced by U.S. Rep. Erik Paulsen (R-Minn.), the bill deals with the FDA’s third-party review process.

The FDA currently uses third parties to review device applications and conduct inspections. According to Paulsen and the bill’s co-sponsors, the FDA’s utilization of third parties could be improved and increased to provide greater efficiency to device companies and patients.

H.R. 3205, titled, “The FDA Renewing Efficiency From Outside Reviewer Management (REFORM) Act,” would reauthorize review and inspection for five years, decrease review time by requiring FDA to review third-party submissions within 30 days of receipt, improve the quality of reviews by providing transparency around decision summaries and total product life cycle information, and ensure standards are kept by requiring third-party reviewers to request re-accreditation every three years.

“By focusing on efficiency and requiring reviewers get re-accreditation every three years, this legislation speeds up patient access to life-saving medical devices while ensuring high-quality reviews focused on patient safety,” said Paulsen. “This common sense legislation will save both the FDA and medical device innovators valuable resources, and ensure we keep and expand jobs here in our communities.”

Paulsen has been working closely with a team of members of the House Energy and Commerce Committee, which has jurisdiction over the FDA. In addition to his own bill on third-party reviews, Paulsen is the original cosponsor of nine other bills that address the least burdensome principle, conflicts of interest, humanitarian-use devices, the de novo process, good guidance practices, international standards, device tracking, reviewer expertise, the FDA’s mission, and ensuring device safety.

“The San Diego life-science cluster is one of the largest in the world, accounting for more than 24,000 jobs in our region. These jobs and American patients are threatened by Washington bureaucracy, unnecessary regulations, and a disturbing culture within the Food and Drug Administration,” said Rep. Brian Bilbray (R-Calif.), a cosponsor of the legislation.“Congressman Paulsen continues to be a leader on these issues.”

FDA and CMS Implement Parallel Review Program

The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have launched a “parallel review” pilot program for concurrent review of medical devices for FDA approval and Medicare coverage.

The FDA and CMS, which will begin accepting submissions immediately, issued procedures for voluntary participation and guiding principles that the agencies will follow during product review.
According to officials from both agencies, FDA and CMS anticipate that parallel review will facilitate the development of innovative new products and increase the efficiency of the review processes for both agencies.

“The pilot program will help the FDA and CMS streamline the parallel review process so that it works efficiently for expedient patient access to safe and effective medical devices,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

Often, device sponsors focus solely on obtaining FDA approval, only to encounter reimbursement roadblocks. Both agencies rely on clinical data in reaching their decisions, and while the two agencies have distinctly different regulatory responsibilities, parallel review can help reduce time between FDA approval and Medicare national coverage determinations.

“The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes. Our goal is to reduce regulatory burden and improve patient outcomes,” said Patrick Conway, M.D., CMS chief medical officer.

The pilot program is voluntary and will not change the existing separate and distinct review standards for FDA device approval and CMS coverage determination. It only is available for qualifying new medical device technologies. Companies should contact the agency to find out more about which devices qualify.

The pilot program, which will last for up to two years with the possibility for extension, will focus on innovative technologies that can benefit from the efficiencies of parallel review. The program will accept no more than three to five submissions per year.

The agencies announced their intention to implement a parallel review program a year ago.