Governor Terry McAuliffe signed the Right to Try bill into law March 26, making Virginia the 11th U.S. state to pass such a bill.
Under the new law, patients with terminal illnesses will have expanded access to investigational drugs, or drugs pending Food and Drug Administration approval. The Goldwater Institute, an organization which lobbies for bills that promote individual freedoms, has supported Right to Try from its beginnings.
“The Goldwater Institute crafted the original model language for the Right to Try laws, and we
have assisted lawmakers in every state where the bill has become law,” said Craig Handzlik, State Policy Coordinator of the Goldwater Institute.
Supporters of Right to Try argue that access to investigational medicines may yield lifesaving results for terminally ill patients. Although limiting patients’ access to drugs that have not been FDA approved is meant as a protective measure, these restrictions may also withhold valuable treatment for long periods of time.
“The FDA’s clinical trials and approvals process takes an average of 10 years and $1 billion to complete,” Handzlik said.
Right to Try seeks to give patients access to investigational medications which show promise.
Terminally ill patients in Virginia will now have the option to access drugs which have passed through the FDA’s first phase of clinical trials. The bill’s supporters hope this will provide treatments faster while keeping patients safe from toxic substances.
However, opponents of this bill argue that it has exactly the opposite effect. Law Prof. Margaret Riley said she believes that Right to Try ultimately slows down the process by which lifesaving drugs are made available to the public. She notes that Right to Try does not actually require drug companies to provide terminally ill patients with access to investigational drugs.
“And when drug companies refuse to do so, it is not because doing so is expensive and burdensome, although it is both of those,” Riley said. “It is because doing so may mean that it may jeopardize or extend the time for the approval of the drug.”
Giving individuals early access to drugs prior to FDA approval may prolong the time it takes for the FDA to approve the drug. This delays the availability of the drug to all terminally ill patients. Additionally, the FDA already selectively permits expanded access to investigational drugs on a case-by-case basis.
“In a number of situations, FDA will allow expanded access — sometimes called ‘compassionate use’ — to an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition,” Riley said.
While Right to Try seeks to provide terminally ill patients with the widest access to the most effective drugs, some health law experts believe this bill is not effective. Instead, the release of new lifesaving drugs to the public may be facilitated by boosting enrollment in clinical trials. This, health law experts argue, would bring safe and effective drugs to the market faster.
“I have no doubt of the good intentions of most of the legislators who vote for such bills,” Riley said. “But they do not seem to fully understand either the legal aspects of the legislation nor the real problems that the legislation is supposed to address.”
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