Writing in JAMA: Journal of the American Medical Association, Patricia J. Zettler, JD, and Henry T. Greely, JD, both of Stanford University, criticize the “strange allure” of states’ laws that recognize patients’ “right to try” new medicines before the Food and Drug Administration (FDA) approves them.
These laws should help patients get access to medicines that the FDA forbids. However, these lawyers point out that the FDA’s power may overwhelm these laws:
Despite the attention they have received, right-to-try laws are unlikely to give patients more access to unapproved drugs or devices. Under the “Supremacy Clause” in the US Constitution, federal law trumps conflicting state laws. For example, states can repeal their laws against medical (or nonmedical) use of marijuana, but the federal government may still arrest and convict people in those states for violating medical marijuana prohibitions. Although the federal government has chosen to limit its enforcement of federal marijuana laws in certain circumstances, the FDA is unlikely to ignore unauthorized use of unapproved products, especially because the agency already provides physicians with a regulatory pathway for compassionate use.
Another reason is that right-to-try laws do nothing to overcome industry’s understandable reluctance to provide experimental drugs and devices outside clinical trials. Manufacturers worry that providing access outside of trials could deplete their limited supplies of experimental products, make them liable for injuries to patients, and make eventual FDA approval less likely…
The latter appears to be a significant obstacle to these laws’ effectiveness. It is hard enough to get drug makers to supply drugs for compassionate use under the FDA’s protocol. Although three states (Colorado, Louisiana, and Missouri) have passed “right to try” laws, I have not seen evidence of drug makers supplying unapproved drugs in those states.