Bradley Merrill Thompson, Strategic Advisor with EBG Advisors and Member of the Firm in the Health Care & Life Sciences practice at Epstein Becker Green, was quoted in RAPS Regulatory Focus, in “Senate HELP Sends User Fee Reauthorization Bill to Floor Vote,” by Ferdous Al-Faruque.
Following is an excerpt:
The US Senate Health, Energy, Labor and Pensions (HELP) committee advanced a bill that would reauthorize the Food and Drug Administration (FDA) to collect medical product user fees. It differs significantly from a sister bill recently passed in the House, meaning it would need to be reconciled in a conference if it is approved by the full Senate.
In a 13 to 9 vote, the HELP committee approved the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act on 14 June. …
However, not everyone agrees that FDA needs the authority. In a recent conversation with Regulatory Focus, Bradley Thompson, an attorney with Epstein Becker Green, said the agency already has the ability to set change parameters when they allow a product on the market.
Related reading:
Bradley Merrill Thompson Quoted in “FDA Should Step In to Help Spur AI/ML Standards”
