Bill Text: NJ ACR138 | 2018-2019 | Regular Session | Introduced
Bill Title: Urges FDA to expedite approval of additional epinephrine auto-injector device products.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced - Dead) 2018-02-08 - Introduced, Referred to Assembly Health and Senior Services Committee [ACR138 Detail]
Download: New_Jersey-2018-ACR138-Introduced.html
ASSEMBLY CONCURRENT RESOLUTION No. 138
STATE OF NEW JERSEY
218th LEGISLATURE
INTRODUCED FEBRUARY 8, 2018
Sponsored by:
Assemblyman HERB CONAWAY, JR.
District 7 (Burlington)
SYNOPSIS
Urges FDA to expedite approval of additional epinephrine auto-injector device products.
CURRENT VERSION OF TEXT
As introduced.
A Concurrent Resolution urging the United States Food and Drug Administration to expedite approval of additional epinephrine auto-injector device products.
Whereas, Insect and food allergies are the leading cause of anaphylaxis, a life-threatening condition that is easily treatable with epinephrine, a medication only available via prescription; and
Whereas, Individuals who are known to be at risk of anaphylaxis may carry emergency doses of epinephrine with them at all times in the form of an epinephrine auto-injector device; and
Whereas, Epinephrine auto-injector devices, which safely deliver a pre-measured dose of epinephrine using a spring-loaded injection mechanism, are a useful tool in administering epinephrine in emergency situations; and
Whereas, Because of their usefulness, many people at risk of a food or insect allergy keep epinephrine auto-injector devices on their person and in their homes, workplaces, and schools. Often, people will acquire a number of devices at one time to ensure they are readily available in case of an emergency; and
Whereas, Many first responders similarly maintain a supply of epinephrine auto-injector devices to have on hand when responding to emergency situations; and
Whereas, New Jersey has enacted a number of laws authorizing persons who complete certain training requirements, including emergency medical technicians, school personnel, and members of the general public, to acquire, maintain, and administer epinephrine using auto-injector devices in various settings, including schools and youth camps; and
Whereas, Because epinephrine loses potency over time, there is a need to obtain new epinephrine auto-injector devices a regular, typically annual, basis; and
Whereas, Since 2009, the price of the only name-brand epinephrine auto-injector currently available on the market, the EpiPen, has increased more than 600 percent, resulting in significant out-of-pocket costs for people without insurance or whose insurance does not provide coverage for the devices. The price increase has similarly affected first responders, youth camps, and other entities that wish to have epinephrine on hand in case of emergency; and
Whereas, There is currently no generic equivalent to the EpiPen that has been deemed therapeutically equivalent by the United States Food and Drug Administration, which limits the ability of pharmacists to offer an affordable alternative to the EpiPen; and
Whereas, Other alternatives to the EpiPen, such as purchasing a vial of epinephrine and a supply of syringes, may be impractical, particularly for children who may experience an allergic reaction at school, and could result in dosage errors, accidental needle-stick injuries, and the spread of bloodborne disease; and
Whereas, The approval of a therapeutically-equivalent alternative to the EpiPen is an essential step in ensuring safe, affordable access to epinephrine for those with the greatest need for this lifesaving drug; now, therefore,
Be It Resolved by the General Assembly of the State of New Jersey (the Senate concurring):
1. The United States Food and Drug Administration is respectfully urged to expedite the approval of therapeutic equivalents to the EpiPen so as to facilitate consumer access to additional safe, affordable epinephrine products.
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 Commissioner of the United States Food and Drug Administration.
STATEMENT
This resolution respectfully urges the United States Food and Drug Administration to expedite approval of a therapeutic equivalent to the EpiPen, which is a name-brand epinephrine auto-injector device that is used to treat the symptoms of anaphylactic shock. Since 2009, the price of the EpiPen has increased more than 600 percent, resulting in significant out-of-pocket costs for many consumers, as well as for first responders, youth camps, and other entities that seek to have epinephrine on hand in case of emergency. Approval of a therapeutically-equivalent alternative to the EpiPen will help ensure that epinephrine is available in safe, affordable forms to those who most need this lifesaving medication.
