Now that President Donald Trump has signed his long-sought â€śright to tryâ€ť law, Americans have a dubious new freedom to bypass the drug quality-control system and experiment with medicines of questionable safety that may or may not work.
This solves no real problem. The Food and Drug Administration has long granted access to medicines that are only partway through the U.S. approval process for patients in extreme circumstances who might benefit. But a myth had spread throughout the land, promulgated by conservative groups, that dying patients were being refused permission to try experimental drugs. Congress responded with a feel-good law.
From now on, these patients - in fact, practically anyone who has been diagnosed with any life-threatening disease or condition, whether or not he or she is near death - will be able to choose to trust doctors and drug companies alone to look out for their well-being.
Thatâ€™s a questionable privilege - and not just because itâ€™s risky.
Before they exercise their right to try, patients will have to persuade the companies to provide the drugs. The new law doesnâ€™t compel the companies to so, and often they donâ€™t want to.
Under the new law, without the FDAâ€™s expert guidance, companies will have even more reason to turn down requests for experimental medicines.
FDA Commissioner Scott Gottlieb has pledged to carry out the new law in a way that promotes access and protects patients. But he has no authority to do anything except issue guidance and receive annual summaries from companies providing investigational drugs.
A word of advice to doctors and patients who choose to sidestep the FDA: Proceed with care, and donâ€™t count on a miracle.