Posted by 29 May 2018
For some people who are dying, the ability to try any treatment option – even if it hasn’t been approved as effective by the FDA – provides hope for their future. Under new legislation passed by Congress, these patients may find it a little easier to access drugs that are experimental but promising.
Under this “right to try” legislation, the Food and Drug Administration would no longer have the authority to stop certain patients from having access to experimental treatments. These patients must have a terminal illness with a prognosis to die within months, have no other treatment options, and not have access to other clinical trials.
People who meet that criteria can work with their doctors to devise a treatment plan that includes drugs that have been proven safe by the FDA, but have not been proven effective. Drug companies would have to agree to provide the drugs, and the patients would bear the cost of those drugs.
The FDA had a program in place where terminal patients could request experimental drugs, but the agency retained the ability to approve or deny these requests.
Supporters of this legislation say that someone facing death should be able to try any drug that may be useful. They contend that the federal government should not be a gatekeeper between patients and potentially life-saving treatments. Opponents of the bill say that it short-circuits necessary safeguards. They also claim that very few people will be eligible for the program, and that those who are will face very high costs for drugs.
The Senate approved this legislation by unanimous consent on August 3, 2017, and the House of Representatives approved it by a vote of 250-169 on May 22.
Do you support terminally ill patients having access to experimental medication? Or should the Food and Drug Administration still be able to oversee the process of providing experimental drugs to patients who are dying?