Senator Mike Hilgers
AGO 18-2
No. 18-002
Nebraska Attorney General Opinion
State of Nebraska Office of the Attorney General
March 27, 2018
SUBJECT:
Constitutionality of LB 117, the Investigational Drug Use
Act, Under the Supremacy Clause of the U.S. Constitution
REQUESTED
BY: Senator Mike Hilgers Nebraska State Legislature
WRITTEN
BY: Douglas J. Peterson, Attorney General, Lynn A. Melson,
Assistant Attorney General
You
have requested an opinion from this office to address your
concerns whether LB 117, the Investigational Drug Use Act,
"if enacted into law, would be preempted by the Food,
Drug, and Cosmetic Act and the Supremacy Clause of the
Constitution." For the reasons set forth below, we think
it is likely that one or more of the provisions of LB 117
could be preempted by federal law.
BACKGROUND
As
described by the principal introducer of LB 117, Senator
Hilkemann, this bill "allows eligible patients under the
Act to be treated with any drug, biological product, or
device that has successfully completed Phase 1 of a clinical
trial but has not yet been approved for general use by the
USFDA [United States Food and Drug Administration, or
"FDA"] and remains in a clinical trial approved by
the USFDA." Committee Records on LB 117,
105th Neb. Leg., 1st Sess. (Jan. 27,
2017) (Introducer's Statement of Intent). He also notes
that such an act is more commonly called a "Right to
Try" act.
Among
its provisions, LB 117 sets out certain criteria for eligible
patients, including having an advanced illness, having a
recommendation from a treating physician, and giving written,
informed consent. Terms such as "eligible patient,"
"advanced illness," "investigational
drug" and "written, informed consent" are
defined. LB 117, § 2. Under the bill, a manufacturer
may, but is not required to, provide the investigational
drug, biological product, or device for treatment. LB 117,
§ 5. Section 11 of the bill further provides that it
does not create a private cause of action against the
manufacturer of an investigational drug or device for harm to
the patient if the manufacturer has complied in good faith
with the provisions of LB 117. The patient's health
insurance carrier is not obligated to pay for such
treatments. The Division of Public Health [of the Nebraska
Department of Health & Human Services] may not take any
action against the license of a health care provider based
solely on the provider's recommendation that the patient
use an investigational drug, biological product, or device
which has not yet been approved by the FDA, and the State of
Nebraska will not block the patient's access to such
medical treatment. LB 117, §§8-10.
According
to one source, "right to try" acts have been
enacted in 38 states since 2014.
http://righttotry.org/faq/. (last accessed on
3/19/18). The provisions of these acts vary from state to
state. However, all are based on the premise of allowing
terminally ill patients to access investigational drugs and
devices that have passed the first phase of clinical trials
required for approval by the FDA.
Federal
legislation concerning the access by patients with advanced
or terminal illnesses to investigational drugs has also been
proposed. The Senate passed S. 204, the "Right to Try
Act of 2017" on August 3, 2017. A somewhat different
"Right to Try Act of 2018", H.R. 5247, was passed
by the House on March 21, 2018.
FEDERAL
FOOD, DRUG AND COSMETIC ACT
Prescription
drugs, biological products and medical devices are subject to
the comprehensive regulation of the Food and Drug
Administration ("FDA") pursuant to the Federal
Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C.
§§ 301 et seq. Relevant to this opinion
are the statutory and regulatory provisions pertaining to new
or investigational drugs. "No person shall introduce or
deliver for introduction into interstate commerce any new
drug, unless an approval of an application filed pursuant to
subsection (b) or (j) of this section is effective with
respect to such drug." 21 U.S.C. § 355(a) (2017).
In other words, a new drug product cannot be marketed until...
