ASSEMBLY, No. 3078

STATE OF NEW JERSEY

219th LEGISLATURE

INTRODUCED FEBRUARY 20, 2020

Sponsored by:

Assemblywoman  ANNETTE QUIJANO

District 20 (Union)

SYNOPSIS

     Requires DOH to make list of drugs with "black box" warnings accessible through its website.

CURRENT VERSION OF TEXT

     As introduced.

An Act concerning the provision of certain prescription drug information to the public and supplementing Title 26 of the Revised Statutes.

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

     1.    The Legislature finds and declares that:

     a.     A "black box" warning is a type of warning that appears on prescription drugs that may cause serious adverse effects, so named for the black border that usually surrounds the text of the warning.

     b.    The federal Food and Drug Administration, or FDA, requires pharmaceutical companies to place a "black box" warning on a drug label if medical studies indicate that the drug carries a significant risk of serious or life-threatening adverse effects.

     c.     A "black box" warning is the most serious warning that the FDA requires to be placed on the label of a prescription medication.

     d.    Advertisements that serve to remind health care professionals of the availability of a prescription drug product, known as "reminder ads," are not allowed for products that carry a "black box" warning on their label.

     e.     In many cases, patients are unaware that they have been prescribed a medication that carries a "black box" warning because the warning is not clearly or conveniently displayed in a manner that is easily identifiable by the patient.

     f.     Physicians and consumers often have to negotiate their way through a variety of websites in order to obtain accurate and current information on "black box" warnings.

     g.    The public interest clearly requires that both prescribers and members of the general public have convenient and timely access to up-to-date information, which is contained in a centralized location, about which drugs are required by the FDA to carry a "black box" warning on their label.

     2.    The Department of Health shall post on its website a list of all drugs that are required by the FDA to carry a "black box" warning on their label.  If the FDA makes this information available to the public on its own website on or after the effective date of this act, the department website may provide a hypertext link to that information as an alternative to posting the list of those drugs.

     3.    This act shall take effect immediately.

STATEMENT

     This bill requires the Department of Health (DOH) to post on its website a list of all drugs that are required by the federal Food and Drug Administration (FDA) to carry a "black box" warning on their label.

     The bill provides that if the FDA makes this information available to the public on its own website on or after the effective date of the bill, the DOH website may provide a hypertext link to that information as an alternative to posting the list of those drugs.

     A "black box" warning, which the FDA requires a pharmaceutical company to place on a drug label if medical studies indicate that the drug carries a significant risk of serious or life-threatening adverse effects, is the most serious warning that the FDA requires to be placed on the label of a prescription medication.