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More states in Midwest enacting 'right to try' laws

by Tim Anderson ~ January 2016 ~ Stateline Midwest »
A nationwide legislative push to give terminally ill patients easier access to experimental medications has succeeded in changing the laws of six Midwestern states over the past two years. In this region, the trend began in late 2014 in Michigan, with bipartisan passage and the governor’s signing of SB 991 and
HB 5649
.
This past year, “right to try” laws were enacted in Illinois (HB 1335), Indiana (HB 1065), Minnesota (SF 100), North Dakota (SB 2259) and South Dakota (HB 1080).
Under these measures, doctors can prescribe certain pharmaceuticals and other medical products that have successfully gone through the first phase of a U.S. Food and Drug Administration-approved clinical trial, but have not yet been approved for general use.
The FDA already has in place a process for allowing patients access to these investigational medicines, under its “compassionate use program.” According to the Regulatory Affairs Professional Society, close to 6,000 requests for experimental drugs were made between 2010 and 2014, and the FDA approved nearly all of them. The new state laws, however, reflect concerns that applying for the federal compassionate-use program is too cumbersome or time-consuming.
They provide a “right to try” certain experimental medications provided that a doctor has advised the use of them and that the patient has exhausted conventional treatments and provided “informed consent” acknowledging the potential risks.
Manufacturers are not required to offer the drug, and insurers do not have to cover the experimental treatments. In addition, the statutory language typically includes liability protections for drug manufacturers and shields health care providers from being sanctioned for prescribing the experimental medications.
Right-to-try bills received near-unanimous support in the six Midwestern state legislatures that approved them.
“What drew my attention to this legislation from the outset is the fact that elected officials from both sides of the political spectrum saw this issue the same way,” Illinois Sen. Michael Connelly wrote in the May 2015 edition of Stateline Midwest as the right-to-try bill made its way through the state General Assembly.
But in October, California Gov. Jerry Brown vetoed legislation in his state, citing recent changes by the FDA to simplify the process for requesting experimental medications under its compassionate-use program.
“Before authorizing an alternative state pathway, we should give this federal expedited process a chance to work,” he wrote in his veto message.
Opponents of these bills have also said they could do more harm than good — by prescribing drugs that have not gone through the full FDA testing process, raising false hopes and causing patients to overspend on unproven drugs.