A bill introduced in the US Senate on Tuesday becomes the latest legislative effort to expand the ability of terminally ill patients to gain access to experimental medicines. The legislation, which joins a companion bill that was introduced in the House last summer, would prohibit the federal government, including the US Food and Drug Administration, from taking any action to prevent patient access.
The bill, which was introduced by Senator Ron Johnson (R-Wis.), comes after 28 states have passed so-called “Right to Try” laws. These allow patients to leapfrog a drug-development process that takes years before new treatments become available. And the laws reflect rising frustration with an FDA program called expanded access, in which people who are seriously ill can obtain a drug under development, even though they aren’t enrolled in a clinical trial.
Under federal law, if terminally ill patients are not eligible to obtain an experimental therapy through a clinical trial, they can apply to the FDA for what is known as compassionate use. The agency actually approves the vast majority of these requests, but as we have noted previously, critics say the federal program is arbitrary and cumbersome.
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