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New law gives dying patients the right to try unapproved drugs

The FDA Commissioner says his agency fully supports the effort

Photo (c) scanrail - Getty Images
President Trump has signed the Right to Try Act, legislation that gives terminally ill patients access to experimental and unapproved drugs.

“Thousands of terminally ill Americans will have the help, the hope, and the fighting chance -- and I think it’s going to be better than chance -- that they will be cured," Trump said at the bill-signing ceremony.

The drug approval process can be long and cumbersome, and terminally ill patients and their families have long asked to be able to try promising, but unproven, treatments before they win approval from the Food and Drug Administration (FDA).

Democrats' concerns

The Right to Try Act passed with bipartisan support, though some Democrats said it could be dangerous because it could give dying patients false hope. Under the measure signed into law, terminally ill patients will be able to use unapproved medical treatments without getting permission from the FDA.

FDA Commissioner Scott Gottlieb said his agency fully supports the new law, and it has already taken steps to improve access to experimental drugs.

"We understand that treatment decisions for those facing terminal illnesses are best made by patients and families, with the support of their treating physicians," Gottlieb said in a statement. "When appropriate, those suffering from a terminal illness who've exhausted available options should be able to access promising treatments being studied in clinical trials, or products under active review by the FDA."

Informed decisions

At the same time, Gottlieb said the FDA would work to make sure patients are fully protected and able to make informed decisions about their treatment.

The new law amends the Federal Food, Drug, and Cosmetic Act to establish a new procedure for making yet-to-be approved drugs and investigational treatments available to patients diagnosed with life-threatening diseases, or who suffer from conditions that have exhausted approved treatment options.

"Our implementation of the Right to Try Act will build on our long-standing efforts to help patients and families who are facing life-threatening diseases or conditions, in a way that seeks to protect their autonomy, their safety, and the safety of others following in their paths," Gottlieb said.

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