Colorado becomes 3rd state with Right to Try law

| Saturday, May 17, 2014, 6:33 p.m.

Colorado, Missouri and Louisiana are poised to become the first states in the nation to give terminally ill patients the right to try experimental drugs without the blessing of the Food and Drug Administration, setting the stage for what could be a lengthy battle over who should decide whether a drug is too risky to try.

Lawmakers in the three states have passed “Right to Try” laws with unanimous votes in recent weeks, after high-profile, social media campaigns in which families of dying patients have pushed for access to unapproved but potentially lifesaving drugs. Colorado's governor signed that state's law on Saturday.

Proponents of the measures argue that patients desperate for treatments must navigate a lengthy, cumbersome process to get the FDA to approve early access to experimental drugs and to persuade companies to provide them. The Right to Try laws are intended to cut through some of that red tape by essentially cutting the federal government out of the picture.

“For people who are facing death and have one last hope, they should have a choice to try every possible drug,” said state Rep. Joann Ginal, a Democrat and co-sponsor of the bill in Colorado. Ginal introduced it in part because she witnessed how an experimental treatment helped her older brother, who has a rare blood cancer.

Opponents of the approach call it an ill-advised effort that circumvents federal law, undermines the drug development process and threatens to harm more people than it helps by providing access to medications that haven't been proven safe and effective.

Frank Burroughs, founder of the Virginia-based Abigail Alliance for Better Access to Experimental Drugs, which has long pushed the FDA to widen access, said people aren't after just any new medication that comes along.

“We're talking about ‘promising' drugs,” said Burroughs, whose group has helped the Goldwater Institute, a conservative advocacy organization, push for the state laws. “Patients are much smarter and savvy than they get credit for.”

Burroughs said the FDA simply hasn't moved quickly enough and that people who are out of options are willing to take on more risk than an ordinary person.

“The risk-benefit is much different than someone who's waiting for a new allergy medication or a new toe fungus cream,” he said.

The FDA on Friday declined to take a position on any of the state Right to Try bills. But in a statement, the agency said it is concerned about any efforts that might undermine the “congressionally mandated authority and agency mission to protect the public from therapies that are not safe and effective.”

FDA regulations allow for access to investigational drugs outside of a clinical trial for patients who have serious or life-threatening illnesses and have no comparable alternatives. While these “compassionate use” exemptions can apply to individuals on a case-by-case basis, the FDA also can grant expanded access for larger groups of patients. However, the agency cannot force a company to provide a drug to patients.

The Right to Try bills aim to provide a streamlined alternative to the FDA process. Instead of having to fill out lengthy and complex paperwork, patients would only need to get an OK from a drug company and a simple prescription or “recommendation” from a doctor to access an unapproved treatment. The drugs involved must have successfully completed an initial safety trial and have moved to the next phase of development.

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