Tags: Colorado | right-to-try | drugs | FDA

Colorado Backs Experimental Drugs for Dying Patients

Monday, 19 May 2014 09:27 AM

The growing pressure to allow experimental drugs to be used on dying patients has been given a vital boost in Colorado, where a so-called "right-to-try" bill became law over the weekend.

Although the measure is the first in the nation, lawmakers in several states are pushing similar legislation that could result in terminal patients receiving therapies still to be approved by the Food and Drug Administration, The Wall Street Journal reported.

The bill, which received unanimous legislative support and was signed by Colorado Gov. John Hickenlooper, does not force drug companies to give test drugs to potential patients outside those taking part in clinical trials.

However, right-to-try supporters hope that the act will lead to faster approval of life-saving drugs that often take years to be approved.

Arizona is due to vote on a right-to-try referendum this fall, while similar bills have been passed by state legislatures in Missouri and Louisiana but are still waiting for the governors to sign off on them, the Journal said.

The Goldwater Institute, a Phoenix-based conservative nonprofit advocacy group that put forward the proposals in these states, says it’s planning to push the measures in legislatures nationwide.

Colorado’s right-to-try act allows terminal patients to take experimental drugs that have cleared early-stage safety trials. The manufacturer must agree to provide them to the patients, while the FDA is no longer required to approve them in that state, as it has in the past.

State Sen. Irene Aguilar, a Denver Democrat and physician who co-sponsored the bill, said, "If a person has been diagnosed with something terminal, and they don't have any hope, and there is something out there they want to try that might work for them, I am supportive of people being able to do that."

The right-to-tryers are hoping their efforts will result in easier access to the new so-called cancer immunotherapies, which unleash the body’s immune system to fight tumors. They shrink tumors and have performed well in early clinical trials.

But the trade group Pharmaceutical Research and Manufacturers of America, warned that the public’s safety is not best served by circumventing FDA oversight, the Journal reports.

Sascha Haverfield, vice president of scientific and regulatory affairs at PhRMA, told the Journal, "Successful completion of the clinical trial process is necessary to demonstrate that an investigational medicine is safe and effective, which is required to obtain FDA approval, so that companies may make the medicine available to a broader patient population when clinically appropriate."

An FDA spokesman says the right-to-try movement is "inconsistent with its congressionally mandated authority and agency mission to protect the public from therapies that aren't safe and effective."

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The growing pressure to allow experimental drugs to be used on dying patients has been given a vital boost in Colorado, where a so-called "right-to-try" bill became law over the weekend.
Colorado, right-to-try, drugs, FDA
Monday, 19 May 2014 09:27 AM
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