The new year is already a busy one for supporters of so-called “right-to-try” laws. A national campaign to allow terminally ill patients to legally get unapproved drugs and devices in each state has made its way to Illinois.
Lawmakers from both parties are throwing their support behind a measure that would make the state the sixth to have a right-to-try law on its books.
The bill would allow drug and device manufacturers whose products are still in the investigational stage to offer those therapies to terminally ill patients once those products have completed Phase 1 clinical trials under the Food and Drug Administration's protocols.
Similar laws were passed last year in Colorado, Louisiana, Missouri, Michigan and Arizona, which in November became the only state so far pass a right-to-try measure by voter referendum. It is still unclear, however, that the laws are actually providing dying patients greater access to experimental drugs compared with what the FDA already permits.
“If there is a chance that a patient suffering from a terminal illness may improve from access to experimental medications, and if the patient is willing to and chooses to accept that risk, government should not stand in the way,” said Republican Illinois state Sen. Michael Connelly, who introduced the bill in the Illinois General Assembly Jan. 15.
As with right-to-try laws either proposed or passed in other states, the Illinois bill was based on proposals originally written by the Goldwater Institute, a Phoenix-based, not-for-profit conservative research organization (PDF) that has led the national lobbying campaign to get state lawmakers across the country to pass similar measures.
At a news conference in Chicago on Friday, Connelly was joined in support of the bill by Democratic state Rep. Greg Harris, along with Goldwater policy adviser Kurt Altman and AIDS Foundation of Chicago Vice President Ramon Gardenhire, who said such laws offer terminally ill patients another chance for life that they would not normally have.
“When those individuals are facing their humanity, they should be able to exhaust all the means available to them to find a cure for the disease that is ailing them,” Gardenhire said. “We stand in strong solidarity with Rep. Harris and Sen. Connelly in making sure we can push this bill over the finish line this session.”
Altman said similar laws are being considered in 23 other states. By passing right-to-try laws through the states, he acknowledged a goal of forming a consensus large enough to put pressure on the federal government to possibly loosen its process for approving investigational drugs.
“At some point the federal government is going to recognize there is an issue out there, and hopefully address it as well, so we can work with each other,” Altman said. “With states and the federal government we'll make the system better.”
Under the proposed Illinois law, patients seeking an investigational drug would be required to get a prescription from a physician after all approved treatment options had been exhausted. Drugmakers and anyone involved in providing and administering the treatments would be immune from lawsuits and disciplinary action by state regulators. State officials could be penalized if they are found to have blocked access of an experimental medication to an eligible patient.
State right-to-try laws do not require pharmaceutical companies to provide unapproved drugs and devices. They also do not call for insurers to cover the costs of those treatments. In fact, payers would not be under obligation to cover any healthcare costs related to the experimental treatment, so patients could have to pay out of pocket for care they need if they suffer a bad reaction.
The FDA already allows for access to investigational therapies for terminally ill patients outside of a clinical trial under expanded or “compassionate” use on a case-by-case basis. The FDA has granted approval in more than 95% of those cases.
Few drugmakers have come out in support of right-to-try laws. Most of them, according to Connelly, have remained neutral. But the Pharmaceutical Research and Manufacturers of America has come out against such legislation.
“We have serious concerns with any approach to make investigational medicines available that seeks to bypass the oversight of the Food and Drug Administration and clinical trial process, which is not in the best interest of patients and public health,” John Murphy, assistant general counsel for PhRMA said in an e-mail in November. “Legislation at the state level, however well-intentioned, is unlikely to add any meaningful new approaches that can optimize the federal expanded access process overseen by FDA.”
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