Steve Ubl

Elizabeth Flores, Star Tribune

Sen. Amy Klobuchar

Jim Mone, Associated Press

Device firms, FDA reach deal on new product OKs

  • Article by: JAMES WALSH and JIM SPENCER
  • Star Tribune s taff w riters
  • February 1, 2012 - 9:20 PM

The medical device industry has agreed to double the fees it pays to the U.S. Food and Drug Administration over the next five years. In return, the FDA will hire more people and speed the process for reviewing new products.

In an agreement announced Wednesday, medical device companies will pay $595 million in fees -- money that will be used by the FDA to review the safety and effectiveness of medical devices. Over the five-year period, the FDA will add more than 200 people to its approval processes that industry leaders have lamented is often too slow.

The agreement strikes a careful balance between what industry agreed to pay and what the agency can accomplish with the amount of funding proposed, the FDA says. Congress must still approve the deal before it goes into effect.

"I think it will create a pathway to quicker approvals, and that is what we really want here," Sen. Amy Klobuchar, D-Minn., told the Star Tribune.

Stephen Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), called the agreement "a potential game changer for the FDA, the industry, but mostly for patients."

Klobuchar, who co-chairs the Senate medical device caucus, said she and Rep. Erik Paulsen, R-Minn., who co-chairs the House medical device caucus, will work together to generate bipartisan support for legislation that is also designed to speed the approval process.

New rules, such as one that loosens conflict of interest rules to increase the number of device reviewers, might have to be tacked on to the user-fee agreement when it reaches Capitol Hill, Klobuchar said. She also said Congress needs to make sure the FDA meets its goals.

"There is some good progress with the benchmarks," Klobuchar said, "But of course, it's all in the details because we have to make sure they get enforced."

Specific elements of the deal, such as the fee structure, are expected to be finalized soon.

Quicker yes or no

Ubl told reporters that he expects the agreement to work because of commitments and compromises on both sides.

Under the goals outlined Wednesday, the FDA would streamline decisionmaking on premarket approval applications from an average of 464 days to 385 days over the next five years. Meanwhile, the 510(k) process, the most common way new devices get to market, would drop from an average of 146 days to 124 days.

The agreement specifically tries to end last-minute requests for information by the FDA -- 11th-hour questions that the industry has said slows the review process. FDA evaluators would be required to meet midway through the review process to give companies time to address concerns.

The FDA must publicly disclose if it does not meet the new standards. The agency must also hire a private-sector management consultant to monitor its progress and recommend corrections if it does not achieve its benchmarks.

Congress first established the user fee program 10 years ago with the Medical Device User Fee and Modernization Act of 2002. The five-year program is set to expire on Sept. 30.

Devicemakers respond

Minnesota, a hub of medical technology, and its congressional delegation have been at the center of the push for faster FDA review of medical devices.

Medtronic and Boston Scientific, worldwide giants in the medical device industry, were part of the negotiating team that forged the agreement with the FDA. Both companies issued statements in support of it. St. Jude Medical of Little Canada was not part of the negotiations and declined comment.

Medtronic, based in Fridley, said it anticipates that the device approval process will "affirm" the FDA's role in assessing safety and effectiveness. "The management improvements envisioned by this new five-year user fee agreement will correct lagging review times and delayed patient access to new therapies," the company said in a statement.

Boston Scientific, which employs about 5,000 workers in the Twin Cities, said it anticipates that the FDA "will be accountable to performance goals that are intended to ensure timely availability of safe, effective and innovative medical devices to U.S. patients."

While the agreement is a "positive step," it doesn't resolve all the issues between the medical device industry and the FDA, said Shaye Mandle, vice president of government and affiliate relations with the trade group LifeScience Alley.

"To ensure the health and global leadership of the U.S. medical device industry," Mandle said, "we must continue to work together to make wholesale improvements to the entire regulatory environment."

James Walsh • 612-673-7428

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