Following its counterparts in the U.S. House of Representatives, the U.S. Senate on August 3 passed a key funding bill for the U.S. Food and Drug Administration (FDA) by a 94-1 vote, according to a report from the Hill.
The bipartisan measure was led by Sens. Lamar Alexander (R-TN) and Patty Murray (D-WA) of the Senate Health Committee. Sen. Bernie Sanders (D-VT) was the lone vote against it.
The bill renews the FDA's authority to collect fees from prescription drug and medical device industries for the next five years. The fees will account for $8 billion to $9 billion and represent more than a quarter of the FDA's funding, the Hill said. The bill will be sent to President Donald Trump for signing.
The Medical Imaging and Technology Alliance (MITA) praised the Senate for passage of the measure, which includes a reauthorization of the Medical Device User Fee Act (MDUFA). This act will improve the predictability, consistency, transparency, and timeliness of the premarket review process, including reduction in 510(k) total time to clearance; presubmission meeting metrics; FDA quality management program and audits; and additional reporting metrics, MITA said in a statement.
"The Senate passage of MDUFA is another critical step toward a victory for patients, the industry, and the agency," said Joe Robinson, chairman of the MITA Board of Directors. "As the bill moves to the White House for signature, we applaud the bipartisan efforts of the House and Senate to find reasonable, common-sense solutions to clear regulatory hurdles that hinder medical innovation and ensure patient access to lifesaving technology."
