USA Today Gets It Right: FDA Should Not Stand in the Way of Dying Patients
A USA Today editorial this week calls for the FDA to be stripped of its power to decree whether dying patients can take experimental drugs that could save their lives. Patients and doctors, the editors write, should be allowed to make this decision without needing the government’s permission. The article describes the lengthy process required to obtain FDA approval:
The process for getting experimental drugs is so daunting that fewer than 1,000 people sought and got federal approval to take such drugs last year.
Food and Drug Administration rules require patients to clear a series of hurdles. First, they and their doctors must find a company to provide its drug. Many drug makers — worried that a patient’s death will spur a lawsuit or harm their chances for final FDA approval — refuse.
Even then, patients still need a hospital review board to sign off, a contract between the hospital and the drug maker, and FDA approval. The FDA application process, according to its own estimates, can take up to 100 hours.
The article comes out in favor of “right to try” laws, which have been passed in three states:
These carefully crafted measures allow patients and their doctors to go directly to a pharmaceutical company to seek access to drugs, but only those that have cleared the first phase of clinical trials and remain in development. The laws protect drug makers from lawsuits. And, pointedly, they seek to cut out the FDA, which now has final say.
My two cents: It is heartening to hear that, in at least some states, terminally ill patients will be able to pursue all their medical options without having to first jump through the FDA’s hoops. But everyone, not just those who are terminally ill, should be free to do this. The government has no rational basis for prohibiting individuals from deciding for themselves the drugs they are willing to take and the treatments they are willing to undergo.