The legislation would allow terminally ill Americans to try medicines that have passed Phase 1 of the Food and Drug Administration approval process. Phase 1 clinical trials usually include 20-100 “healthy volunteers or people with the disease/condition,” the FDA says. The purpose of the phase is to identify the safety of the drug and what dosage is best. Around 70 percent of drugs in Phase 1 move on to the next phase. Drugs in Phase 1 are not yet available through prescriptions from doctors.
What is a Right to Try bill? Here’s a look at the legislation the president called for Tuesday.
What are Right to Try laws?
Right to Try laws allow terminally ill patients to have access to drugs and/or therapies that have not been fully approved by the FDA. The Right to Try laws are state laws. Trump called for a federal Right to Try law. Thirty-eight states have passed Right to Try laws.
Which states have Right to Try laws?
The states that have passed Right to Try laws are: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, Washington and Wyoming.
What happens if you live in a Right to Try state and have a terminal disease?
According to righttotry.org, “You and your doctor should discuss best treatment options for your condition. If those options include a qualifying investigational drug your doctor believes is your best hope, he/she can initiate contact with that drug manufacturer’s compassionate use program director to discuss your options for access.”
Righttotry.com offers a sample letter to be sent to drug manufacturers.
Right to Try by the numbers
Fewer than 3 percent of terminally ill patients gain access to investigational treatments through clinical trials.
Compassionate use exceptions are only granted to about 1,200 patients a year.
Who would be eligible for “Right to Try”? (From righttotry.org)
- The patient has a terminal disease and has exhausted all conventional treatment options;
- The patient's doctor has advised the use of an investigational medication;
- The medication has successfully completed basic safety testing and is part of the FDA's ongoing approval process;
- The patient has provided "informed consent" acknowledging the potential risk of the drug; and
- The company developing the medication is willing to make it available to the patient.
- Right to Try includes important protections. The basic safety testing and informed consent requirements protect the patient. And doctors and the manufacturer are protected from liability if the investigational medication doesn't work. But this is not protection from medical malpractice.
If there are state laws, why did the president ask for a federal one?
According to righttotry.org, "FDA regulations cannot preempt state laws that preserve constitutionally protected rights, such as the fundamental right to life and medical self-preservation. The U.S. Supreme Court has never addressed Right to Try specifically, but it has held that states have great latitude in regulating health and safety, including medical standards, which are primarily and historically a matter of local concern."
Where is Congress on a federal law?
Sen. Ron Johnson, R-Wis., introduced a Right to Try bill in January 2017. The bill passed Aug. 3. A companion bill is in the House Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
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