State lawmakers should pass legislation protecting the freedom of prescription drug manufacturers to share information about possible off-label uses of drugs with health care providers and insurers, a new report by the Goldwater Institute states.
Off-label use is application of a drug to treat an ailment other than the medical condition for which the U.S. Food and Drug Administration (FDA) initially approved the drug.
For years, FDA has prosecuted manufacturers for allegedly “misbranding” drugs after manufacturers have shared information about potential off-label uses, according to “Restoring Free Speech in Medicine,” published by Goldwater in June.
States can protect the right of manufacturers to inform health care providers and insurers more fully about their products by fortifying constitutional protections of speech, the report states.
“The U.S. Constitution provides a floor of protection for individual rights, not a ceiling, leaving states free to enact laws that protect those rights more broadly than the federal Constitution does,” the authors wrote.
Off Label, On Target
Off-label drug use constitutes one-fifth of all prescription drug use, the report states.
Naomi Lopez-Bauman, coauthor of the report and Goldwater’s director of healthcare policy, says FDA rules prevent providers from understanding how drugs have been and can be used.
“Gagging manufacturers about truthful, lawful off-label [use] is at odds with the rapid availability of health care information in the twenty-first century that holds so much promise for medical advances and treatments,” Lopez-Bauman said. “By protecting free speech in this area, manufacturers would be free to share truthful information about the lawful ways their treatments can be and are being used off-label.”
Limiting Useful Information
The prevalence of off-label use makes it easy for doctors to run afoul of FDA restrictions when giving their patients the best possible treatment, Lopez-Bauman says
“Because of federal gag rules on the sharing of information about off-label treatments, doctors are at an increased risk of making prescribing mistakes,” Lopez-Bauman said. “There is also the risk that a doctor may not know about better treatment options to care for their patients, especially when the patient has a rare or deadly disease and few options exist.”
FDA regulations prevent doctors and patients from making fully informed decisions about treatment, Lopez-Bauman says.
“The lack of information can be particularly harmful in highly specialized areas such as oncology, where a cancer patient’s on-label treatment options have either failed or don’t exist,” Lopez-Bauman said. “Only when doctors and payers are fully informed about the lawful treatment options available to them can they best serve their patients’ individual needs.”
States vs. Overreach
States can protect the right of manufacturers, providers, and insurers to share information about off-label uses of drugs under their constitutions and the U.S. Constitution, the report states.
Christina Sandefur, executive vice president for Goldwater and a coauthor of the report, says state-level protections of free speech are immune from federal government overreach.
“Federal law cannot preempt state law when the federal law or act itself is unconstitutional,” Sandefur wrote in the Summer 2017 issue of the Cato Institute magazine Regulation. “When the FDA silences truthful, scientific speech about lawful treatments, it is violating the constitutional right to free speech.”
Arizona Expands Protections
Arizona has passed the Free Speech in Medicine Act, allowing members of the health care industry to share research about off-label drug uses under state law. The bill passed each house unanimously and was signed by Gov. Doug Ducey (R) in March.
Sandefur says the law invites drug manufacturers to tell providers and patients the whole truth about their products.
“The end result will be that pharmaceutical companies will no longer have to fear state or federal prosecution for sharing truthful information about lawful treatments and will speak more freely,” Sandefur told Health Care News.
Lopez-Bauman says expanding free speech protections regarding health care is a political win for all parties.
“In a time when health care is so politically divisive, this reform offers an opportunity for positive reforms that can improve care and allow patients to access innovative treatments sooner,” Lopez-Bauman said.
Brandon Best ([email protected]) writes from Cedarville, Ohio.
Christina Sandefur, “Protecting Free Speech in Medicine,” Regulation, Cato Institute, Summer 2017: https://heartland.org/publications-resources/publications/protecting-free-speech-in-medicine
Naomi Lopez-Bauman and Christina Sandefur, “Restoring Free Speech in Medicine,” Goldwater Institute, June 6, 2017: https://goldwater-media.s3.amazonaws.com/cms_page_media/2017/6/6/Free%20Medicine%20-%20Final.pdf
Arizona House Bill 2382, 53rd Legislature, March 2017: http://www.azleg.gov/legtext/53leg/1r/bills/hb2382p.pdf
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