The Senate appears poised to move forward on the House-passed FDA Reauthorization Act (FDARA) (H.R.2430) after Sen. Ron Johnson (R-WI) agreed to pull back his threat to hold up the bill. Majority Leader Mitch McConnell (R-KY) has committed to taking up an amended version of Sen. Johnson’s right-to-try legislation to the floor in a separate vote, clearing the way for Senate consideration of the user fee package. FDARA would renew and enhance the FDA drug, medical-device, biosimilar, and generic-drug user-fee provisions. The legislation, which passed the House on July 12, is nearly identical to a similar package (S. 934) which cleared the Senate HELP Committee in May on a bipartisan basis. If an agreement reached by leadership holds, FDA could be passed by unanimous consent with no amendments as soon as 11:00am today.
Meanwhile, it’s also expected that Sen. Johnson’s bill, known as the Trickett Wendler, Frank Mongiello and Jordan McLinn Right to Try Act (S. 204) — which is being referred to as a “sidecar” — will be taken up by unanimous consent. Right-to-try legislation is broadly intended to provide terminally ill patients access to experimental drugs and treatments outside of clinical trials. An amended version of Sen. Johnson’s bill reportedly scales back the national liability shield in the original bill, widens the scope of the proposed law to non-right-to-try states, imposes pricing, labeling, and promotional constraints on the investigational drugs, and requires adverse event reporting to FDA.
Additionally, lawmakers are expected to pass by unanimous consent a bipartisan opioids bill (S. 581) from Sen. Joe Manchin (D-WV) that would require the Department of Health and Human Services (HHS) to develop standards for hospitals and physicians to denote a patient’s history of opioid addiction in medical records. Specifically, the bill directs FDA to develop standards that: (1) consider the potential for addiction relapse or overdose death if a patient recovering from addiction is prescribed opioids; (2) require that a history of opioid addiction be displayed in a manner “similar to other potentially lethal medical concerns” such as drug allergies; and (3) require medical professionals have access to the opioid information to ensure they can prescribe medically appropriate medication.
While future scheduling for the Senate remains fluid, there are growing expectations that the upper chamber will start its August recess at the end of the legislative day today.