Senators Bring Back Medical Technology Caucus

Senators Bring Back Medical Technology Caucus

Who says bipartisanship is dead? When it comes to saving high-tech jobs and continuing to foster U.S. innovation, there’s a lot of room for agreement in both parties. Senators Scott Brown (R-Mass.) and Amy Kloubchar (D-Minn.) have crossed the aisle to renew a caucus focused on medical technology. They will co-chair the caucus.

Clearly, support for the medical device industry seems to be gaining steam on Capitol Hill lately. Both Brown and Klobuchar represent communities where the medical device business has deep roots, pockets and ties—not to mention hundreds of thousands of jobs.

The caucus likely will focus much of its upcoming attention on the 2.3 percent excise tax impacting the medical technology sector and changes to the U.S. Food and Drug Administration’s 510(k) clearance process for devices.

High-tech medical device businesses “not only spark medical breakthroughs, they save lives,” Klobuchar said in a written statement.

“Every day in every state small medical technology companies are driving the innovation agenda we need to compete in a global economy,” she wrote. “I will continue to work to make sure that Minnesota remains a leader in healthcare innovation by developing innovative products while maintaining patient safety.”

Brown said Massachusetts has more than 200 medical device companies and hundreds of pharmaceutical-related companies, “all of which provide good-paying jobs to thousands of citizens.”

Brown echoed Klobuchar’s sentiment.

“It is critical that we provide a business environment for them to innovate, grow and thrive,” Brown wrote. “I’m pleased to be the Republican chair of this bipartisan caucus, and look forward to working with my colleagues on both sides of the aisle to give our medical device and technology companies the tools and resource they need to continue their important work.”

The United States is the only net exporter of medical devices and has a $5.4 billion annual trade surplus.

The Advanced Medical Technology Association (AdvaMed)—the industry’s largest trade group—was quick to laud the move.

“Beyond our contributions to patient care, our industry is the acknowledged world leader and has been an engine of economic growth and a reliable source of high-paying jobs for American workers. But America’s leadership is increasingly challenged by foreign competitors supported by foreign governments who see the economic value that the medical technology industry provides. For American industry to compete successfully in today’s global economy, sound public policy is essential,” Stephen Ubl, AdvaMed’s president said in a prepared release. “Today’s re-launch of the Medical Technology Caucus will help ensure there is a strong bipartisan coalition in the Senate with a special focus on promoting medical technology innovation, patient access to quality care, and the international competitiveness of America’s medical technology industry.”

Congressman Launches Website for Device Tax Repeal

U.S. Rep. Erik Paulsen (R-Minn.) is stepping up his efforts to abolish the medical device excise tax.

One of the most outspoken critics of the 2.3 percent tax, Paulsen has launched a website to help medical device industry executives better voice their concerns to Congress about the levy and other medical technology issues. The site’s debut occurs just two months after Paulsen introduced bipartisan legislation to repeal the device tax, a move he claims will stifle growth, innovation and access to the “life-saving technologies” available in the United States. The tax is set to take effect in 2013.

“Minnesota is home to nearly 400 medical technology firms, 200 of which are located in my district,” he noted. “The House Medical Technology Caucus is an important forum for my colleagues and I to fight for these high-tech jobs and the addition of this new website further broadens our ability to inform and educate others on the issues that are critical to the medical technology industry. The website also expands our connectivity and engagement with medical technology companies, industry experts, and doctors and patients who use the products the industry creates.”

The House Medical Technology Caucus was founded in 1993 to help educate its members and staff about the various issues facing the medical technology sector. Paulsen is co-chairman of the Caucus.

Speaking at a recent LifeScience Alley event, Paulsen called the device tax a “burden” on the industry. He’s been trying to repeal the tax since the passage of healthcare reform legislation last year, but he acknowledged at the event that repealing the tax would create a $20 billion funding gap.

Two months ago, Paulsen introduced bipartisan legislation to the U.S. House of Representatives to immediately repeal the device tax. Dubbed the Protect Medical Innovation Act, the bill had 41 original cosponsors and now has 110 supporters in the House.
Companion legislation also was introduced in the U.S. Senate by Sen. Orrin Hatch (R-Utah).

Paulsen called the bill a “common-sense initiative” and urged his colleagues to find common-sense ways to provide affordable healthcare. A $20 billion levy on the device industry, he said, will only hike insurance premiums as well as the price of medical products.

The United States Chamber of Commerce agrees with Paulsen. In a March 22 letter from R. Bruce Josten, the chamber’s executive vice president for government affairs, the organization contends the tax will lead to increased healthcare costs. “In the current weak economy, this tax will undermine the industry’s ability to create and maintain well-paying jobs in the United States and hinder the development of breakthrough treatments,” Josten wrote.

Knee Device Maker Snubs FDA’s Offer for New Hearing

So much for forgiving and forgetting.

Proving that resentment and hard feelings—as well as old habits—can indeed die hard, ReGen Biologics Inc. has rebuked an offer by the U.S. Food and Drug Administration (FDA) for one final hearing about the revocation of clearance for its Menaflex knee implant.

Vowing to bring the controversial product to the U.S. market by other means, Hackensack, N.J.-based ReGen called the FDA’s offer of a final hearing “futile.” In an unusually long news release, ReGen Biologics Chairman and CEO Gerald E. Bisbee Jr. said the company “believes that…any [such] hearing…would be a costly and futile exercise…ReGen has no interest in continuing to be a pawn in bureaucratic infighting aimed at reforming the FDA’s 510(k) review process.”

“The safety and effectiveness issues surrounding the clearance of our device were settled years ago, at a Nov. 14, 2008, advisory panel meeting,” Bisbee noted. “The independent experts on that panel were completely in Menaflex’s favor. The only issues that require remediation are the blatantly arbitrary and unfair processes of the FDA, and those aren’t on the table in a Part 16 review. Enough is enough.”

Last fall, the FDA decided to rescind the 510(k) clearance it granted ReGen in 2008 for its Menaflex Collagen Scaffold, an absorbable mesh implant designed to encourage the re-growth of damaged knee cartilage. As a result, ReGen must keep the device off the market until it can prove its safety and effectiveness to the FDA’s satisfaction. The FDA told the company that it wants to discuss the “appropriate marketing pathway for the device” as well as the kind of data needed to provide a “reasonable assurance of safety and effectiveness.”

Menaflex won FDA approval through the agency’s 510(k) premarket notification, a process in which a manufacturer needs only to show that its product substantially is the same as a “predicate” drug or device already approved by the FDA—and therefore is as safe and effective. The decision, however, soon came under fire by members of Congress who questioned whether the agency had properly followed its procedures and succumbed to undue pressure from the manufacturer. In September 2009, the FDA agreed to reevaluate its decision.

“There were in fact numerous departures from the review process,” Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said about the CDRH’s 2008 decision. “There is no adequate information in the record establishing why the device was approved.”

After reevaluating its decision, the FDA said it concluded that Menaflex was “technologically dissimilar” from other surgical-mesh devices the agency had approved, and it embodied differences that could affect its safety and effectiveness. Unlike predecessor products that repair or reinforce damaged tissue, for example, Menaflex helped the human body grow new meniscal tissue.

“Because of these differences, the Menaflex device should not have been cleared by the agency,” the FDA said in a news release.

The FDA’s about-face infuriated Bisbee, who called the move “totally unbelievable.” He blamed the agency’s change of heart on politics.

“The agency’s clearance of Menaflex has become a political football and the FDA is not playing by the rules,” Bisbee said in a statement last October following the FDA’s decision.
“Regen has invested 58 months and more than $30 million to meet (the center’s) requirements only to have the agency reverse decisions made by previous officials by stating that they were in error with no substantial evidence that is true.”

In his 18-page letter to the FDA (dated March 21), Bisbee accuses the FDA of failing “repeatedly to provide ReGen with a fair and impartial review process related to the review of Menaflex. ReGen therefore has no reason to believe that the FDA will conduct a … hearing in an unbiased and impartial manner.”