In the near future, I will be introducing legislation to protect Pennsylvanians’ access to prescription drugs approved through the U.S. Food and Drug Administration’s Accelerated Approval pathway.

The FDA’s Accelerated Approval pathway was created to help patients facing serious or life-threatening illnesses access promising therapies earlier, particularly when they have limited treatment options. This pathway has played an important role in advancing treatments for cancer, rare diseases, HIV/AIDS, and other serious conditions. Drugs approved through Accelerated Approval remain FDA-approved drugs and are still subject to scientific review, including clinical trial evidence, full safety review, manufacturing review, and post-approval confirmatory studies.

Unfortunately, some health insurers have adopted policies that categorically restrict or delay coverage of drugs simply because they were approved through the Accelerated Approval pathway. In some cases, these drugs are treated as “experimental” despite having been approved by the FDA. These blanket restrictions can create unnecessary barriers between patients and potentially life-saving or life-changing therapies.

My legislation would prohibit insurers, Medical Assistance managed care plans, and CHIP managed care plans from excluding, restricting, or delaying coverage of a prescription drug because it was approved by the FDA under the Accelerated Approval pathway. The bill would also prevent medical-necessity determinations from being based on the fact that a drug received Accelerated Approval.

This proposal is not a coverage mandate. It does not require a plan to cover any particular drug, nor does it prevent insurers from using appropriate formulary design, utilization management, or individualized medical-necessity review. Rather, it ensures that coverage decisions are based on nationally recognized medical standards, governmental guidelines, current medical and scientific evidence, and the needs of the patient—not an arbitrary distinction based on the FDA approval pathway used.

Patients facing serious and life-threatening illnesses should not be denied access to FDA-approved therapies simply because those treatments reached patients through a pathway specifically designed to expedite access where unmet medical need exists. This legislation will help ensure that Pennsylvania’s insurance practices keep pace with medical innovation while preserving appropriate clinical review.

Please join me in co-sponsoring this important legislation.