What Is The Potential Liability For Physicians In Prescribing Experimental Drugs Still In Clinical Trials?

The U.S. Senate is approving “right-to-try” legislation that will allow individuals with life-threating conditions to use drugs which are still in the trial process, also known as the experimental phase, where the Food & Drug Administration (FDA) has yet to approve them. The law is expected to also pass the House, as strong support exists, particularly at the state level. 

Over 25 states have instituted some variation of “right-to-try” laws, largely touted by libertarian and conservative groups like the Goldwater Institute. The bill was originally sponsored by Senator Ron Johnson of Wisconsin, who says the law will help those “facing mortality without hope”. Among the critics is the American Society of Clinical Oncology (ASCO) who says that the law leaves patients without FDA protection and that it may not guarantee access to these medications. Patients who have already tried all available remedies may be eligible for “right-to-try”.

The original proposal was intended for those with a terminal illness; however, it has been revised to include those whose disease may result in death. Physicians may be liable for medical malpractice with this enactment. Originally, the bill provided immunity for makers of the product, those who prescribe them, and those who dispense these drugs. 

With a recent amendment, a physician who prescribes these drug products can be held liable if their conduct is determined to be grossly negligent, done with intent, or if the acts are willful or wanton. The FDA has an existing “compassionate use” option available, and approves the vast majority of the requests that it receives.

Recent debate has included some of the following points:

• Supporters say the laws will expand access and that the FDA compassionate use option is too slow; however, the FDA says that they handle non-emergency requests in roughly four days and emergencies often the same-day
• ASCO suggests that the FDA expanded-access program has improved and renders this “right-to-try” legislation unnecessary
• Manufacturers have no limitations on how they price the products; therefore, only wealthier patients potentially could have access
• The FDA expanded-access program does have manufacturer product pricing caps

Those who are denied approval for the current FDA program may appeal, but the process is slow and time-consuming. The majority of states reportedly do not have a system to assist physicians in obtaining the experimental medications, despite that they are required to make the request on behalf of the patient. 

Medical insurance providers generally do not cover products lacking FDA approval and alternative options to fund them are not available. It is also important to remember that medications that have only cleared Phase 1 of the multi-phase process of obtaining FDA approval have only proven the safety of a product; therefore, there is no established evidence of efficacy.