AdvaMed fleshes out its priorities for Congress

The medical device lobby group AdvaMed on Tuesday shared its priorities for the new US Congress as the legislative session gets underway. Among its asks, the group wants lawmakers to pass diagnostics reform and hold the Food and Drug Administration accountable to its user fee commitments.

On 28 February, AdvaMed published a list of its priorities for the 118^th Congress. The group discussed some of its priorities with Focus in January. (RELATED: AdvaMed sets out its priorities for new Congress, Regulatory Focus 17 January 2023)

AdvaMed CEO Scott Whitaker said the timing of the release of its priorities was intentional. The group wanted to wait until after President Biden’s State of the Union address to Congress.

"He rolled out his agenda to Congress, and we thought a couple weeks after that would be a good time for industry to roll out our agenda to Congress,” said Whitaker. “The president's budget will be coming soon, so there can be a series of budget hearings and a whole series of things that goes on in the first quarter of this year.”

“So, the timing was intentional to allow Congress to get seated and begin their work, let the president make his remarks at the state of the Union, and then drop our agenda for them,” he added.

AdvaMed continues to call on Congress to pass the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would give FDA explicit authorities to regulate laboratory-developed tests (LDT). The test had strong bipartisan support last year but failed to get passed.

FDA Commissioner Robert Califf has said that if Congress does not pass diagnostics reform, he will consider using rulemaking to regulate the tests.

AdvaMed is also asking Congress to reauthorize the Pandemic and All Hazards Preparedness ACT (PAHPA), which would provide support for the nation’s stockpile of medical devices, diagnostics and other medical countermeasures to prepare for another potential pandemic.

AdvaMed is also asking Congress to ensure that FDA holds up its end of the deal under the latest Medical Device User Fee Amendments (MDUFA V). It is calling on Congress to work with the lobby group to monitor FDA’s roll out of the Total Product Lifecycle Advisory Program (TAP) pilot to ensure it complies with the MDUFA V requirements. The group also wants Congress to hold FDA to meeting its hiring and performance targets.

"Congress's job is to help make sure that the goals are met through hearings and through questions and inquiry that can help make sure the FDA is accountable for what they said they were going to do and that's what we're asking them to do in the simplest form," said Whitaker.

AdvaMed also wants Congress to help make sure the US maintains its leadership in the global medtech market. Some of the group’s concerns include making sure that countries such as China allow US medtech companies into its market and addressing potential problems arising from the implementation of the European Union’s medical device and in vitro diagnostic reforms. The group is also asking lawmakers to use trade agreements to secure commitments to address cross-border issues such as best regulatory practices, regulatory harmonization and health care supply chain prioritization.

AdvaMed also called on Congress to take steps to improve clinical trial diversity, ensure the Environmental Protection Agency (EPA) doesn’t institute overly burdensome regulations on the use of ethylene oxide (EtO) to sterilize medical products and to make sure the Centers for Medicare and Medicaid Services (CMS) allows reimbursement for products with breakthrough designation through the proposed Transitional Coverage of Emerging Technologies (TCET) initiative.

AdvaMed fleshes out its priorities for Congress

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