A Diagnostics & Imaging Week

By a vote of 93-1, the Senate last week passed the FDA Revitalization Act, which would reauthorize the Medical Device User Fee and Modernization Act (MDUFMA) and includes other device-related provisions.

The single “no” vote was cast by Sen. Bernard Sanders (I-Vermont), an outspoken critic of the pharmaceutical industry who said he was “extremely disappointed” that the bill did not legalize imports of lower-priced medicines from Canada.

The agreement between industry and the FDA regarding medical device user fees was unveiled last month by Advanced Medical Technology Association (AdvaMed; Washington). The proposed schedule features lower user fees for small companies on their first submissions and a slight tightening of timelines for reviews by the agency.

In a statement Thursday following Senate passage of the FDA Revitalization Act, AdvaMed president/CEO Stephen Ubl said the association “commends the Senate for its swift and bipartisan approval of legislation that will help ensure American patients have timely access to the latest lifesaving and life-enhancing medical technologies.”

In particular, Ubl credited Sens. Edward Kennedy (D-Massachusetts) and Michael Enzi (R-Wyoming) for their leadership in moving the bill quickly through the committee process to a final vote on the Senate floor.

“We are pleased that the FDA Revitalization Act preserves the agreement negotiated between FDA and the medical technology industry to reauthorize the [MDUFMA] and that the Senate approved this agreement as negotiated,” Ubl said. “The agreement provides additional resources to FDA to hire additional reviewers providing patients with access to safe, lifesaving medical devices in a timely manner. The agreement also provides manufacturers with a more predictable fee schedule with regard to user fee rates. And it provides additional protections for small business as well.”

The new fee schedule for small companies is somewhat less demanding than before, with first 510(k) applications being reduced from 80% to the full fee of $3,404 to half the full fee, or $1,702.

For first-time PMAs and PMA supplements, firms grossing less than $100 million would pay only a quarter of the full fee, down 13 percentage points from the 38% of the full fee imposed by MDUFMA.

That comes out to a fee of $46,000 compared to the full fee of $185,000.

Congress is expected to pass a version of the bill before the fiscal year ends in September because it reauthorizes the user fees the FDA collects from the drug and device industries.

The House also is expected to pass its version before the September deadline.

“AdvaMed encourages the House to consider companion legislation as soon as possible so that a bill can be sent to the President’s desk prior to the September 30th expiration of the program,” Ubl said.

Kennedy, chairman of the Senate Health, Education, Labor and Pensions committee, also released a statement in response to the passage of the FDA Revitalization Act.

“This landmark legislation creates a stronger [FDA] and sets forth a new and better direction for the safety of drugs we take and the food we eat,” Kennedy said in the statement. “Almost half of all Americans take at least one pill a day, so this legislation will make a difference in the life of every American family. From prescription drugs to pacemakers to chemotherapy to the food we eat, the FDA protects the health of hundreds of millions of Americans — often in ways we barely realize.”

The statement continued: “In this new era of the life sciences, medical advances will continue to bring immense benefits for our citizens. To fulfill the potential of that bright future, we need not only brilliant researchers to develop the drugs of tomorrow, but also strong and vigilant watchdogs for public health to guarantee that new drugs and medical devices are safe and beneficial, and that they actually reach the patients who urgently need them.”

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