A review of legal databases was unable find any liability lawsuits against pharmaceutical companies related to four years’ worth of products used under expanded access, according to a study by FDA researchers.
The threat of legal action — and its effects on eventual FDA approval — is frequently mentioned as a barrier to drugmakers’ participation in expanded access and compassionate use programs, which involve the use of unapproved drugs in terminal patients.
The researchers said they sought to provide a perspective on the likelihood of a drug’s approval and possible liability risks to commercial sponsors in providing access to investigational drugs.
Insulating companies from any liability following adverse events in the experimental treatments — with some drugs only completing Phase I human testing — has been a fixture of federal “right-to-try” laws currently being considered on Capitol Hill, as well as laws that have been passed in over 30 states.
From fiscal 2010 through 2014, the FDA received nearly 5,400 individual patient expanded access applications, approving 98 percent of them.