Legal Review: Should the Federal Government Expand Access to Experimental Drugs?

By personal injury and insurance bad faith lawyer Scott Glovsky, who is barred and practices in the state of California with the Law Offices of Scott Glovsky.

In 2017, California enacted a law that allows terminally-ill individuals to ask pharmaceutical companies to allow them to access experimental drugs that have not yet been approved for public consumption.

The idea behind the law is simple, the drug trial and approval process is long and arduous and many of the patients that may benefit from the drugs in question may die well before the drug is approved for the public. Therefore, it allows drug companies to provide access to experimental drugs, if the company so chooses, to terminally ill patients prior to Food and Drug Administration (the FDA) approval and without opening itself up to liability in the event the drug causes the patient to die earlier.

Much like legalization of marijuana, however, there are federal rules that govern access to experimental medications that cannot be trumped by state law and drug companies that allow access to experimental medications risk having their drugs denied approval if a patient outside of the regular clinical trial process has an adverse reaction or dies from the medication.

As development of these medications and conduct of drug trials is expensive, drug companies are loathe to risk drug approval for one desperate patient and often decline to allow access outside of the clinical trial.

President Trump has come out in support of a national “Right to Try” law that would allow drug companies to provide access to terminally ill patients without risking any ongoing clinical trial.

Versions of the law have been floated and one that passed the Senate last year prohibited the FDA from using patient outcomes from a “Right to Try” situation in determining whether to approve a drug, unless it was critical to determining a drug’s safety.

The drug approval process is stringent for a reason. As dangerous drugs sometimes end up with FDA approval, how many would be on the market without the oversight that is currently in place? But for people with no other options who are facing death, the possibility that their lives could even be extended for a little while overcomes any fear they may have about a drug’s lack of testing.

“Regardless of how much testing is required, sometimes drugs end up on the market that cause people injury and sometimes death. The testing conducted by the FDA is critical,” said Scott Glovsky, a Pasadena Dangerous Drug Lawyer. “However, terminally ill individuals that may benefit from a drug in testing should have the opportunity to access those medications, provided they understand all of the possible consequences. Even a small extension on life can be a huge benefit.”