Senate Committee Approves Legislation to Speed Approval of Medical Devices

Thursday, March 10, 2016

A Senate committee Wednesday approved a slate of bills that would relax requirements for approval of medical devices by the Food and Drug Administration, part of a larger effort aimed at speeding up the regulatory process and boosting medical research.

Most of the measures were approved with bipartisan support, but the there are indications of discord on the package. Some patient-safety advocates said the legislation would weaken the FDA’s ability to ensure the dependability and safety of medical devices.

The bills approved Wednesday are expected to become part of comprehensive medical legislation that also could provide a big budgetary boost to medical research at the National Institutes of Health. New money for the NIH is a priority of Democrats and the Obama administration.

Democrats on the Health Education, Labor and Pensions Committee had been expected to show greater opposition to the health-regulatory measures. But over the weekend, Democratic and Republican Senate staffers resumed talks that had broken down weeks before, according to people familiar with the talks.

In negotiations that lasted past 2 a.m. Saturday, Democrats won some concessions. In one bill that would simplify the approval process for devices considered “breakthrough” products, for example, the Republicans agreed to substantially narrow the number of devices covered.

“I would not have been voting yes had a lot of work not been done,” said Sen. Tammy Baldwin (D., Wis.) Wednesday during the votes.

At issue is how aggressively the FDA will regulate medical products. The “breakthrough” bill, for example, would allow the use of shorter or smaller clinical studies and quicker measures of success, and medical-device safety experts have already expressed concern that the standards for device approval are significantly lower than those for drugs.

Committee Chairman Sen. Lamar Alexander (R., Tenn.) said Wednesday’s action “gives us a substantial start” to writing a measure that could serve as a companion bill to one passed by the House last year.

The bills approved Wednesday, as well as some the committee approved last month, are expected to be folded into the broader FDA and NIH funding legislation. President Barack Obama is seeking upward of about $1 billion annually for new cancer research, a genetic program called the Precision Medicine Initiative, money for young scientists’ research and other projects.

Still at issue, Mr. Alexander said, is how much money his party will approve for new research at the NIH, “and how to pay for it.”

Funding is a key issue. Sen. Elizabeth Warren (D., Mass.) said she “will not support any of these bills until we have agreement” on new funding for both the NIH and FDA.

Regardless, some consumer groups oppose the bills passed Wednesday.

The “breakthrough” bill “sets a low bar to qualify for ‘breakthrough’ status’ ” and “lowers standards for safety and effectiveness,” said Diana Zuckerman, president of the National Center for Health Research in Washington, a medical research and advocacy group.

One of the breakthrough-product bill’s sponsors, Sen. Orrin Hatch (R, Utah) said that “by streamlining the approval process and improving regulatory certainty, we’re giving more patients a fighting chance to improve their lives.”

JC Scott, a senior official of AdvaMed, the medical-device industry association, said bills passed Wednesday “ensure more timely patient access to the latest medical innovations.”

He said the “breakthrough” bill specifically “builds on initiatives already under way within FDA to help create an accelerated and more predictable pathway.”

“We are concerned that the focus of these bills is on getting medical products to market more quickly, instead of making sure that they are safe and effective,” Dr. Zuckerman wrote on behalf of her group and 13 other medical safety groups in a letter to the senators on the HELP committee.

 

Source : wsj.com