In 2014, Colorado enacted the nation’s first Right to Try Law. Right to Try Laws are designed to allow terminally ill patients access to investigational drugs that have not been approved for public use by the U.S. Food and Drug Administration. Forty states followed Colorado’s lead and enacted Right to Try.
On May 30, 2018, President Donald Trump signed federal Right to Try legislation, which he praised for its potential to save “hundreds of thousands of lives.” At the one-year mark of the federal law, it’s fair to ask whether Right to Try has lived up to its promises and expectations. Based upon the available evidence, it has not.
In concept, Right to Try should provide terminally ill patients with one more tool in fighting their last, most important fight. The laws remove the FDA from the decision-making process and empower patients and their physicians to utilize investigational drugs without first asking for the FDA’s permission.
In practice, Right to Try is fatally flawed. It depends on a drug company’s willingness to provide its investigational drugs to patients outside FDA purview and approval. The law does not obligate a company to do so. Each company must weigh the benefits of providing its drug to a patient versus the possibility that the FDA will punish it in the future for its decision. That is a no-win situation for patients.
While the FDA has several early access drug programs available, they are time intensive and the FDA can ultimately deny access. Right to Try laws eliminate the FDA in theory, but not in reality.
Congress and state governments can enact measures that might strengthen Right to Try, but ultimately Congress must restrict the FDA’s monopoly and overreach in drug development, access and approval to assist patients. The FDA’s drug approval process was last changed significantly in 1962 and those changes resulted in enormous growth in the FDA’s size and jurisdiction. As a result, it now takes on average 10-12 years and $2.8 billion to bring each new drug to market.
In the past 57 years, technology, testing, record keeping and treatment have changed. It is time for Congress to reform the FDA to reflect these changes while ensuring safety, allowing greater access and promoting individual liberty and patient choice.
Kurt L. Hellmann
public affairs consultant