Ken Alltucker , The Republic | azcentral.com
Arizona wants to hand drug companies a powerful tool the federal government now forbids: the authority to promote drugs for uses beyond what they are approved.
The Arizona Legislature unanimously passed and Gov. Doug Ducey signed on March 21 House Bill 2382, which allows drug and medical-device companies to “engage in the truthful promotion” of drugs and devices to medical professionals.
The federal Food and Drug Administration oversees how drug manufacturers market prescription drugs. Companies can sell a drug to the public only after the FDA evaluates medical studies and determines that a drug is safe and works.
Pharmaceutical companies are forbidden from promoting drugs beyond approved uses. But doctors are allowed to prescribe drugs “off label” for ailments other than what the FDA has approved. Such off-label prescribing is common and accounts for up to 20 percent of drug sales, and it’s even more common for specialties like cancer care.
Industry watchdogs say it’s important to limit drug-industry influence over off-label promotion because it could lead to improper prescriptions, wasteful health-care spending and even poor outcomes for patients.
More freedom sought to promote drugs
The new Arizona law will allow drug-company representatives to share information with doctors or other licensed prescribers that is “not misleading, not contrary to fact and consistent with generally accepted scientific principles.” The measure passed 29–0 in the Senate and 60–0 in the House.
Arizona lawmakers believe pharmaceutical representatives should have more freedom to promote drugs directly to doctors, even for uses that have not been fully vetted by the FDA.
Rep. Phil Lovas, R-Peoria, said he sponsored the bill at the request of the Goldwater Institute, a Phoenix-based conservative think tank that pushed for the legislation, which it calls the Free Speech in Medicine Act.
“I thought this was a good idea,” Lovas said. “The drugs are legal. Prescribing is legal. The only thing illegal was for the (drug) company to talk to the physician about off-label uses.”
While Lovas believes the bill will eliminate legal barriers that bar drug companies from off-label promotion, some experts aren’t convinced the bill will have much immediate influence.
Because the pharmaceutical industry must answer to the FDA under federal law, most large companies may be reluctant to promote off-label uses to doctors, nurse practitioners or other prescribers.
“Most of the pharmaceutical manufacturers, because they operate in all 50 states, generally would be hesitant to change their current practices,” said Mark Boesen, a University of Arizona College of Pharmacy instructor and CEO of GenRx Pharmacy in Scottsdale.
Companies that run afoul of FDA’s off-label rules risk fines or costly lawsuits.
Fear of lawsuits
Since 2004, more than 30 pharmaceutical companies have spent billions of dollars to settle False Claims Act lawsuits involving off-label promotion of drugs. That includes Medicis, a former Scottsdale-based company, that paid $9.8 million in 2008 to settle claims that it marketed a skin cream for infants with diaper rash even though the FDA limited the medication to people older than 10.
More recently, Insys Therapeutics, a Chandler-based drug company, has faced numerous state and federal investigations for its off-label sales of Subsys, made from the powerful painkiller fentanyl, that is sprayed under the tongue of patients.
A half-dozen former Insys executives and managers were arrested and charged last December with conspiring to defraud health insurers and bribing doctors to prescribe the powerful and addictive Subsys.
Insys, in a statement issued last December, said that it is cooperating with “all relevant authorities in its ongoing investigations and is committed to complying with laws and regulations that govern our products and business practices.”
The prospect of costly settlements — or worse — could make large pharmaceutical companies skeptical of changing business practices in Arizona when there is no comparable law in other states, experts say.
“The large, ethical pharmaceutical companies won’t participate,” said Dr. Ray Woosley, founder of Credible Meds, which promotes medication safety. “They will be taken to court, fined, and people could get hurt.”
But Woosley added that some smaller companies may take a chance to accelerate off-label promotion in Arizona.
“It will be those smaller companies that are willing to take the risk so they can expand the market and make more money at the risk of patients and prescribers,” said Woosley, a former UA College of Medicine dean.
Knocking down regulatory barriers is goal
Goldwater Institute representatives said the bill is intended to knock down regulatory barriers between drug companies and doctors.
“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,” said Christina Sandefur, a Goldwater Institute executive vice president who contributed language to the bill.
Naomi Lopez-Bauman, the Goldwater Institute’s director of health policy, said the organization’s goal is to replicate Arizona’s off-label prescribing bill in other states.
If off-label promotion bills are passed in other states, UA’s Boesen said it may be similar to the rapid growth of legalized marijuana. Marijuana use is forbidden by federal law, but 29 states and the District of Columbia have adopted laws legalizing marijuana for medical use, recreational use or both.
‘Right to try’ wins approval
It’s not the first time the Arizona Legislature has approved bills that take aim at the highly regulated medical industry.
The Goldwater Institute pushed for and Lovas also sponsored a resolution that led to the state’s “right to try” ballot measure, which voters overwhelmingly approved in 2014.
Right-to-try laws, which give terminally ill patients potential access to experimental drugs that have not been fully vetted by the FDA, have been adopted by 33 states, and President Donald Trump has signaled his support for the concept.
However, since Arizona passed the ballot measure in 2014, neither Lovas nor the Goldwater Institute could identify a single example of a terminal patient who has received medication under the bill.
“I am not aware of any cases,” said Lopez-Bauman. “We don’t track them … We do know of some (cases) across the country.”
In 2015, the Legislature also passed a bill pushed by Theranos that allowed consumers to order blood and other lab tests without a physician’s order.
Theranos is the embattled Silicon Valley blood-testing startup that shut down its retail lab businesses and faces numerous lawsuits from patients who claimed inaccurate test results led to heart attacks or other health issues.