ASSEMBLY JOINT RESOLUTION

No. 176

STATE OF NEW JERSEY

219th LEGISLATURE

INTRODUCED JULY 2, 2020

Sponsored by:

Assemblywoman  VALERIE VAINIERI HUTTLE

District 37 (Bergen)

SYNOPSIS

     Urging FDA to remove restrictions on mifepristone.

CURRENT VERSION OF TEXT

     As introduced.

A Joint Resolution urging the United States Food and Drug Administration to remove restrictions on mifepristone.

Whereas,  Mifepristone is an evidence-based treatment prescribed for the management of early pregnancy loss; and

Whereas,  The United States Food and Drug Administration (FDA) has placed regulations on mifepristone, implementing a Risk Evaluation and Mitigation Strategy (REMS) which requires that mifepristone can only be dispensed in clinics, medical offices, and hospitals under the supervision of a certified healthcare provider; and

Whereas,  REMS restrictions were placed on mifepristone when the drug was first approved, but the last two decades have demonstrated that the drug's side effects are reasonably minimal and can be well-managed; and

Whereas,  These restrictions on mifepristone make it difficult to access care, especially for low-income patients that might have to arrange transportation and childcare to receive treatment; and

Whereas,  Because mifepristone can only be dispensed in clinics, medical offices, and hospitals, patients may experience difficulties obtaining the drug because of inconsistent supply across healthcare facilities, as opposed to the established supply-chain and convenience of commercial pharmacies; and

Whereas,  The FDA restrictions may also lead some patients to obtain mifepristone over the internet, which poses significant product safety and quality risks; and

Whereas,  Mifepristone has been proven to be safe and effective when prescribed through telemedicine and can be safely taken in a patient's home; and

Whereas,  In 2016, the FDA lessened restrictions on mifepristone, by increasing the terms of use from seven to 10 weeks and removing the requirement of patients remaining in the healthcare facility for the full duration of the drug administration; but, patients are still required to register with clinics and keep extensive records of their treatment; and

Whereas,  It is imperative that the FDA completely removes the restrictions on mifepristone in order to promote the well-being of patients in this State; now, therefore,

     Be It Resolved by the Senate and General Assembly of the State of New Jersey:

     1.    The Governor and the Legislature of the State of New Jersey urge the United States Food and Drug Administration to lift Risk Evaluation and Mitigation Strategy restrictions on mifepristone.

     2.    Copies of this resolution, as filed with the Secretary of State, shall be transmitted by the Clerk of the General Assembly or the Secretary of the Senate to the President of the United States, the United States Secretary of Health and Human Services, and the United States Commissioner of Food and Drugs.

     3.    This joint resolution shall take effect immediately.

STATEMENT

     This joint resolution urges the United States Food and Drug Administration (FDA) to lift Risk Evaluation and Mitigation Strategy restrictions on mifepristone.  Mifepristone is an evidence-based treatment prescribed for the management of early pregnancy loss.  The FDA has placed regulations on mifepristone, implementing a Risk Evaluation and Mitigation Strategy (REMS) which requires that mifepristone can only be dispensed in clinics, medical offices, and hospitals under the supervision of a certified healthcare provider.  

     These restrictions on mifepristone make it difficult to access care, especially for low-income patients that might have to arrange transportation and childcare to receive treatment. Because mifepristone can only be dispensed in clinics, medical offices, and hospitals, patients may experience difficulties obtaining the drug because of inconsistent supply across healthcare facilities, as opposed to the established supply-chain and convenience of commercial pharmacies.  The FDA restrictions may also lead some patients to obtain mifepristone over the internet, which poses significant product safety and quality risks.

     In 2016, the FDA lessened restrictions on mifepristone, by increasing the terms of use from seven to 10 weeks and removing the requirement of patients remaining in the healthcare facility for the full duration of the drug administration; but, patients are still required to register with clinics and keep extensive records of their treatment.  It is imperative that the FDA completely removes the restrictions on mifepristone in order to promote the well-being of patients in this State.