Right to Try legislation, which has already been passed in 37 states, is now being considered at the national level. The legislation, which aims to remove the FDA from the equation when granting patients access to unlicensed drugs, has been backed by both President Donald Trump and Vice President Mike Pence. After the Senate unanimously voted in favor of the legislation earlier this year, the Trickett Wendler Right to Try Act of 2017 now moves on to the House of Representatives, where many terminally ill and desperate patients hope it will receive similar support.
However, FDA commissioner, Scott Gottlieb, has recently pushed back against claims that the FDA is a roadblock for patients trying to access investigational drugs. At a House subcommittee meeting in early October, Gottlieb argued that the FDA is largely in favor of unlicensed medicines use as long as it is deemed appropriate and safe.
According to the FDA commissioner, the real barrier to unapproved medicines access is drug supply issues. As such, he believes passing legislation which removes the FDA from the equation, but does nothing to address supply constraints, will do very little to help terminally ill patients access investigational therapies.
While Gottlieb’s point is valid, critics of Right to Try have pointed to a number of other issues that are also not addressed in the proposed Right to Try legislation. For example, many companies refuse to allow access to their investigational products because they worry that any adverse events will be held against them when applying for FDA approval. Other manufacturers do not have the budget, time, manpower or knowhow to manage a program for unlicensed drug supply alongside the clinical trial. Further still, many manufacturers worry that, if they start supplying patients outside the clinical trial, trial efforts will lag as a result, and it will take longer than anticipated to get the drug to market.
There has been no evidence to suggest that the Right to Try legislation would help solve any of these additional issues that limit access to unlicensed drugs. As such, Gottlieb believes it would be better for legislators to focus their time and efforts on improving the current FDA Expanded Access framework, rather than on passing a Right to Try law.