Arizona on Tuesday became the fifth state to approve a law allowing dying patients to try medical devices and drugs not yet approved by the FDA.
The "right-to-try" law gives terminally ill patients access to drugs and devices that have completed Phase One clinical trials, but are still in the investigational stage.
Now, patients who want to try an investigational drug may get a prescription from a physician provided all other treatment options have been exhausted. The law shields doctors, drug manufacturers, and all other involved parties from state disciplinary action and lawsuits.
State officials who block access to treatments for eligible patients could be charged with a misdemeanor offense and be subject to up to six months jail-time. However, pharmaceutical companies are not required to provide unapproved treatments, and insurers are not asked to cover the costs.
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Pharmaceutical Research and Manufacturers of America (PhRAM), the industry's leading trade group, opposes the right-to-try laws because they contradict federal regulations and statutes, but advocates say Arizona's approval displays further public support.
"I think there's a general consensus in the public that an element of the FDA's process is broken," says Victor Riches, VP of external affairs for the Goldwater Institute, a not-for-profit that lobbies for such measures. "It's really a sign that there's a desire from the public at large to do something to make sure that these terminally ill patients have access to medication."
Goldwater created legislation that served as a template for the right-to-try laws in place in Arizona, Colorado, Louisiana, Missouri, and Michigan. The institute has targeted 10 more states to lobby for similar measures. Riches says that getting more states to support right-to-try laws puts more pressure on the federal government to lessen the restrictions on investigational drugs.
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The case against right-to-try
Opponents of right-to-try laws call them ineffective, arguing states cannot overturn or bypass federal laws.
"It's purely an anti-government, political move that imposes no obligations on anyone other than impinging federal law," says Henry Greely, director of the Stanford University Center of Law and the Biosciences. However, he acknowledges that states' decisions over time could pressure FDA to loosen compassionate-use limits.
Currently, the FDA allows dying patients to have access to investigational therapies on a case-by-case basis, although it grants approval in 99% of requests. But proponents argue FDA's reviews for compassionate-use take too long, and that applicants may die during the months-long process.
The real issues are patients' lack of awareness about the policy and the struggle to afford treatments, says Arthur Caplan, director of the medical ethics division at the New York University Lagone Medical Center. Right-to-try laws do not address those problems, Caplan says.
Other critics say increased access to investigational drugs will lead to fewer clinical trial volunteers and warn that insurance plans are not required to pay for treatment of side effects (Johnson, Modern Healthcare, 11/5 [subscription required]).
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