LANSING, Mich. (AP) — Michigan’s Republican-led Legislature has blocked proposed regulations of a breakthrough gene therapy that combats some blood cancers, citing concerns that patients could not access the treatment.
The Senate and House voted to reject the new rules on voice votes Wednesday, over objections from Democrats who said no hearings were held and warned the move is unconstitutional.
The dispute involves the 11-member state Certificate of Need Commission’s unanimous vote in September for standards governing immune effector cell therapy, which includes what is known as CAR-T. The Food and Drug Administration first approved the therapy in 2017, for childhood leukemia, and later for non-Hodgkin’s lymphoma.
Side effects can be grueling, even life-threatening, but it is seen as a promising treatment with a steep cost of approximately $800,000.
The commission, which is within the state Department of Health and Human Services, voted to require hospitals and other sites wanting to provide the treatment to get its approval and be accredited by the Foundation for the Accreditation of Cellular Therapy, or FACT. Michigan’s FACT-accredited hospitals are in Detroit, Grand Rapids and Ann Arbor.
Under state law, the Legislature or governor can disallow the regulations within 45 days.
Sen. Curt VanderWall, a Ludington Republican, sponsored the measure.
“This treatment … is bringing patients back from the brink of death and giving them a new chance at life — a chance that shouldn’t be taken away by bureaucratic hurdles and unnecessary regulations,” he said, saying it may be best for some patients to be treated in an outpatient setting rather than traveling hours to a hospital. He noted that in August, when Medicare said it will cover the therapy for some blood cancers, it determined the special accreditation was not necessary.
Democrats opposed the resolution on legal and process-related grounds.
Sen. Winnie Brinks of Grand Rapids said a 2000 Michigan Supreme Court ruling requires the Legislature to pass a regular bill — not a concurrent resolution — for its action to be binding. Rep. Frank Liberati of Allen Park said the measure was never vetted or debated by a joint legislative committee that reviews actions taken by the Certificate of Need Commission.
Democratic Gov. Gretchen Whitmer also expressed concerns.
“The governor believes the state should be doing what’s best for cancer patients,” said spokeswoman Tiffany Brown. “The administration is open to a discussion about whether a different standard is needed for the safest setting to provide this cancer treatment, however, we have concerns about the Legislature’s legal authority to take this unilateral action, which overrides a decision made by medical experts.”
The Legislature’s move was applauded, however, by conservative groups such as Americans for Prosperity and the Mackinac Center for Public Policy.
CAR-T uses a different strategy than other gene-therapy techniques. Instead of trying to fix disease-causing genes, it focuses on the patient’s immune system, specifically the T cells that battle foreign substances in the body. CAR-T helps the body’s own T cells do a better job of spotting tumors.
Senate Concurrent Resolution 14: http://bit.ly/2JyO6uA