PHOENIX, Ariz. (March 24, 2017) – Earlier this week, Arizona Gov. Doug Ducey signed a bill into law that allows pharmaceutical companies to talk to healthcare providers about alternative uses for approved drugs despite FDA prohibition of such communication. The law sets the stage to nullify the federal law in effect.
Rep. Phil Lovas (R-Peoria) sponsored House Bill 2382 (HB2382). Titled the “Free Speech in Medicine Act,” the legislation opens the door for pharmaceutical companies to talk to doctors and healthcare providers about “off-label” uses for approved drugs despite federal prohibition.
When the FDA approves a drug, it does so for specific uses, doses and age-ranges. But further research and practical application often reveals the same drug can effectively treat other conditions, or can be administered in different doses or to different age ranges. Doctors can legally prescribe FDA-approved drugs off label – meaning for a different use or dosage. But federal law prohibits pharmaceutical companies from discussing off-label uses with healthcare providers. A drug company representative simply talking to a doctor about a potentially effective treatment for a patient could face federal criminal charges.
HB2382 authorizes “truthful promotion of an off‑label use of a drug, biological product or device,” and prohibits state enforcement of the federal law that bans such communication.
Notwithstanding any other law, an official, employee or agent of this state may not enforce or apply section 32‑1967 against or otherwise prosecute a pharmaceutical manufacturer or its representative for engaging in truthful promotion of an off‑label use of a drug, biological product or device.
Notwithstanding any other law, the Arizona state board of pharmacy, the Arizona medical board, the Arizona board of osteopathic examiners in medicine and surgery and the department of health services may not revoke, fail to renew or take any other action against the license of a pharmaceutical manufacturer or its representative, a health care institution or a physician solely for engaging in truthful promotion of an off‑label use of a drug, biological product or device.
The House passed HB2382 by a 60-0 vote. The Senate approved the measure 29-0. With Ducey’s signature, the law will go into effect 90 days after the legislature adjourns.
The Goldwater Institute drafted the model legislation that HB2382 was based on. The organization said the law will expand the number of treatment options in a doctor’s tool kit, enhance patient medical autonomy and increase access to healthcare.
“Curbing the exchange of information about off-label treatments by those with the most knowledge about the drug’s uses, risks, and side effects not only prevents patients from receiving the best possible care; it violates the constitutional right to free speech,” Goldwater Institute executive vice president Christina Sandefur said.
The new law does not attempt to block FDA enforcement of federal law, but prohibits any state cooperation in enforcement efforts, and protects Arizona doctors and healthcare providers from any state sanctions based on their discussions with drug companies.
Although the new law only addresses one small aspect of FDA regulation, it provides a clear model that demonstrates how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself, which has proven to be very effective.
EFFECTIVE
Based on James Madison’s advice for states and individuals in Federalist #46, a “refusal to cooperate with officers of the Union” provides an extremely effective method to render federal rules and regulations unenforceable because most enforcement actions rely on help, support and leadership from the states. This new law could effectively end enforcement of the FDA law against pharmaceutical companies communicating information about off-label treatments to doctors in the state.
LEGAL BASIS
An Arizona state constitutional amendment passed in 2014 explicitly affirms the state’s right to “exercise its sovereign authority to restrict the actions of its personnel and the use of its financial resources to purposes that are consistent with the Constitution.”
The amendment and HB2382 rest on a well-established legal principle known as the anti-commandeering doctrine. Simply put, the federal government cannot force states to help implement or enforce any federal act or program. The anti-commandeering doctrine is based primarily on four Supreme Court cases dating back to 1842. Printz v. US serves as the cornerstone.
“We held in New York that Congress cannot compel the States to enact or enforce a federal regulatory program. Today we hold that Congress cannot circumvent that prohibition by conscripting the States’ officers directly. The Federal Government may neither issue directives requiring the States to address particular problems, nor command the States’ officers, or those of their political subdivisions, to administer or enforce a federal regulatory program. It matters not whether policy making is involved, and no case by case weighing of the burdens or benefits is necessary; such commands are fundamentally incompatible with our constitutional system of dual sovereignty.”
