Sen. Romney Opposes Drug Importation as the Senate HELP Committee Advances User Fees

June 16, 2022

The Senate Health, Education, Labor and Pensions (HELP) Committee voted 13 to 9 on Tuesday to advance user fee reauthorization legislation – the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act – which was fine tuned under a managers amendment. The committee’s action sets the stage for future floor consideration.

Sen. Mitt Romney (R-UT) joined seven of his Republican colleagues, including ranking committee Republican, Sen. RIchard Burr, in voting against the legislation. Democrat Sen. Bernie Sanders (I-VT) also voted against the measure.

Of particular interest to Utah’s life sciences industry is a provision included in the managers amendment that would require the FDA to issue regulations to allow the personal importation of drugs from Canada, which includes additional patient protections to ensure importation does not pose additional risk to health and safety.

Sen. Bernie Sanders (I-VT) offered an importation amendment that would allow wholesalers to import drugs from Canada and the UK, and authorize the FDA after two years to permit the import of drugs from other Organization for Economic Co-operation and Development countries. The amendment was much broader than the importation provision in the managers amendment and would have given a green light to foreign online pharmacies. The amendment was tabled.

Romney spoke out against the importation amendment, arguing that importing drugs from foreign countries is tantamount to placing price controls on pharmaceutical products, which he opposes.

Other amendments of interest include the following:

• Sen. Tommy Tuberville (R-AL) proposed an amendment that would exempt academic centers from the Verifying Accurate Leading-edge IVCT Development (VALID) Act. VALID Act supporters argued that such a provision was unnecessary since VALID would not apply to test-makers who serve populations of 10,000 or less. The amendment was tabled.
• Senator Roger Marshall, MD (R-KS) offered an amendment that would require a GAO report on unique consideration for certain entities in implementing the VALID Act. The amendment passed.
• Sens. Mike Braun (R-IN) and John Hickenlooper (D-CO) offered an amendment that would give FDA authority to allow predetermined change control plans for cleared and approved artificial intelligence/ machine learning (AI/ML) medical devices. The amendment passed.
• Sen. Jacky Rosen (D-NV) offered an amendment that would require FDA to update its medical device cybersecurity guidances every two years instead of every four. The amendment passed.

The Senate HELP Committee user fee bill differs in many ways from its sister bill which passed the House last week with strong bipartisan support. The two bills will have to be reconciled before heading to the President’s desk.

Legislative text of FDASLA as introduced last month is available HERE.

The managers’ amendment the committee passed is available HERE.

A section-by-section that reflects the managers’ amendment is available HERE.