- Associated Press - Thursday, February 12, 2015

DOVER, Del. (AP) - Delaware lawmakers announced Thursday that they are introducing a bill allowing terminally ill patients access to experimental medicines that have not received final approval from the Food and Drug Administration.

The so-called “Right to Try” bill is similar to legislation already passed by five states and introduced in 26 others this year. It is aimed at helping patients diagnosed with terminal illnesses circumvent what supporters say is the FDA’s time-consuming and complicated process to authorize “compassionate use” of or “expanded access” to drugs still undergoing clinical trials.

“The bottom line here is … we have the potential to save some lives,” said chief bill sponsor Sen. Colin Bonini, R-Dover.

FDA spokeswoman Sandy Walsh said the agency has not taken a position on any state’s “Right to Try” law, and supporters said they are not worried about a legal challenge.

Bonini compared such legislation to an Oregon “right to die” law that was challenged by the federal government as a violation of the federal Controlled Substances Act because it involved the prescribing of lethal doses of drugs to terminally ill patients. The U.S. Supreme Court upheld the Oregon law in a 2006 ruling.

Kurt Altman, national policy adviser and general counsel for the Arizona-based Goldwater Institute, which is leading the state-level legislative efforts, said he believes it is a proper exercise of states’ rights under the Constitution and is not pre-empted by federal law.

“If challenged, we would prevail,” he said.

Walsh, meanwhile, noted that the FDA has allowed to proceed more than 99 percent of “expanded access” submissions it received during fiscal years 2010-2014.

“The FDA attempts to allow these submissions to proceed quickly and, in the case of emergencies, may provide authorization over the phone,” she said in an email. “The FDA believes the process works well overall, and has resources available to help physicians navigate the process.”

But supporters of the state legislation say it can take several months to navigate the FDA compassionate-use process, time that some terminally ill patients may not have.

The legislation allows people diagnosed with cancer and other terminal illnesses and their doctors to decide whether to pursue treatment with investigational drugs that have passed the first initial safety phase of the FDA approval process but are not yet available in pharmacies.

The bill does not require pharmaceutical companies to supply the drugs in such instances, nor does it obligate health insurance providers to cover the treatment. The legislation also provides immunity from liability under state law for anyone who prescribes or supplies investigational drugs for use by eligible patients.

Despite passage of right-to-try legislation in Arizona, Colorado, Louisiana, Michigan and Missouri, it does not appear that any patients have yet reached agreements with drug companies to receive investigational drugs, Altman said, noting that the laws are only a few months old.

“We have had no pushback from the pharmaceutical industry,” he said.


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