Drugs

‘Right-to-Try’ Legislation Would Hurt Patients: Ethicist

David McFarland

— 2 min read
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Medical ethicist Arthur Caplan and two other Health Affairs bloggers warn that “right-to-try” legislation that purports to give terminally ill patients the right to try experimental drugs outside of a clinical trial “will do nothing to make companies more likely to grant patients access to their experimental drugs and will only make patients more vulnerable to actors looking to profit from their desperation.” The post says the right-to-try bills “will do more harm than good. Nonetheless, right-to-try proponents are making a strong push to have this legislation included in the user fee legislation that funds FDA, which is currently being negotiated.”

The post asserts that right-to-try legislation is based on two myths — that FDA’s expanded use program is slow and ineffective, and that the legislation will allow patients faster and more guaranteed access to experimental drugs by cutting FDA out of the process.

“In fact,” the authors say, “it is hard to imagine how the agency could provide a faster turnaround time on expanded access requests while still conducting a thorough review of a patient’s medical history and proposed treatment plan.” They note that the form doctors submit takes less than an hour to complete and FDA, which approves more than 99% of such requests, responds on average within four days and can provide an answer in an emergency in one day or less.

“The central objective of right-to-try legislation is to end FDA oversight over the use of experimental drugs,” Caplan and his colleagues say. “For terminally ill patients, ending FDA oversight over experimental drugs would expose the patients to exploitation without guaranteeing access to the drugs they seek. And weakening FDA puts everyone else who takes drugs or uses medical devices or vaccines at grave risk.”

The post notes that the decision to provide or not provide experimental drugs is left with drug companies and the legislation “does not give patients a ‘right’ to access experimental drugs. It simply gives them a right they have now — to beg.”

The authors list several steps that Congress could take that would facilitate access to experimental drugs and thus be more effective than a right-to-try law: 

  •          explore, with the pharmaceutical and biotech industries, ways to make expanded access a more appealing prospect to companies;
  •          strengthen and improve FDA’s expanded access program;
  •          allow FDA to require that doctors report additional data from expanded access attempts to the agency;
  •          encourage FDA to better educate healthcare professionals and researchers on the expanded access program;
  •          eliminate institutional review board oversight for single-patient expanded access protocols; and
  •          use legislative and other means to promote access to and equity in clinical trial enrollment.

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