Modernization of Patient Access Act

Task Forces: Health and Human Services

Draft Disclaimer

Prior to task force meetings, ALEC posts these legislative member-submitted draft model policies to our website. The draft model policies are then discussed, debated, and voted on by ALEC task force members. Policies that receive final approval by legislators on the ALEC Board of Directors become official ALEC model policy. Draft model policies that fail to become official ALEC model policy are removed from the website.

Summary

This proposed model legislation pursues a unified "trigger bill" for approval of a new medication – should the Food and Drug Administration (FDA) grant approval and the Drug Enforcement Administration (DEA) reschedule a new medication for specific medical purpose, state(s) agencies of jurisdiction will recognize that change. Importantly, safeguards in place are robust due to the narrow focus on both FDA approval and DEA rescheduling as the triggers for action at the state level. This is not to be conflated with any actions or decisions regarding the regulation of a drug class, illicit drugs, or other use cases outside of the FDA-approval prescription medical model.

Model Policy

This model legislation does the following:

  • Ensures consistency with federal drug scheduling:
    • Requires that any medication approved by the U.S. Food and Drug Administration (FDA) that is subsequently scheduled or rescheduled by the U.S. Drug Enforcement Administration (DEA) be assigned the same schedule under state law automatically, making newly approved medical treatments available like all other approved medicines.
  • Preserves patient access:
    • Once the FDA approves a medical product, the DEA must place it in a schedule other than Schedule I, that medication would automatically be treated as a controlled substance that can be prescribed in the state.
  • Ensures patients can have better, more individualized options: 
    • Patients deserve access to tailored, evidence-based treatments with the potential for faster symptom relief and fewer adverse effects, and doctors need every appropriate, FDA-approved tool available to meet diverse patient needs.
  • Supports access to innovation:
    • By aligning state law with FDA and DEA actions for new medications, the bill ensures doctors can prescribe newly approved and appropriately scheduled medications without unnecessary state delays, giving patients access to important new treatment options as soon as they are federally authorized. It also creates efficiencies for state legislators to ensure the state is safely and appropriately keeping pace with medical innovations. 

Why It’s Needed:

  • Mental health is a crisis we can’t ignore. 1 in 5 Americans suffer from serious mental conditions, and there haven’t been new therapies in decades.
  • Failure to close the gap means continued suffering. Over 49,000 Americans die by suicide annually, and mental illness costs the United States $282 billion each year.
  • Veterans in particular could benefit greatly from modernization and access to other treatment options. 17 veterans die by suicide every day, and PTSD and depression largely remain undertreated. Current medications often fail or worsen symptoms, and a new solution is long overdue.
    • New treatments, call for general policy modernization to expand access to tools that show promise in enhancing veterans’ care.
  • Timing matters. Proactive policy reform and regulatory efficiency are needed now to ensure states are ready to deliver FDA-approved treatments without delays caused by outdated or misaligned frameworks.

Be It Enacted By The Legislature Of The State Of [State]:

Section 1. This Act May Be Cited As The “Modernization Of Patient Access Act.”

Section 2. Any compound, mixture or preparation that is approved by the United States Food and Drug Administration and that is scheduled or rescheduled by the United States Drug Enforcement Administration to A schedule other than schedule I of the controlled substances act (P.L. 91-513; 84 stat. 1242; 21 United States code sections 801 through 904) is A controlled substance for the purposes of this chapter and may be prescribed in this state.