I was surprised by your editorial "A Right to Try Arrives" (May 23), which praises just-passed legislation that would permit terminally ill patients to seek drugs not yet approved by the FDA directly from the manufacturer. This alters the status quo hardly at all. As NYU School of Medicine bioethicist Arthur Caplan said, right to try is "nothing more than a right to beg a company, that right already exists, and you're really not doing much to help anybody gain access to much of anything."
Moreover, federal regulators are already implementing a version of right to try. From 2010-15 the FDA approved more than 99% of applications for "compassionate use" of unapproved drugs, and since then has worked to simplify the process.
The right to try unapproved drugs has the potential to be compassionate and sound public policy, as well as an important statement about individuals' freedom to make choices, but the legislation enables patients to request medicines after only the most meager safety testing—Phase 1, which is usually performed in a small number of healthy volunteers. About three-quarters of drugs that pass Phase 1 will ultimately fail to be approved because they founder on the grounds of safety or lack of efficacy. And of those that do ultimately gain approval, often the use for which the FDA approves them (as well as the dosage regimen) will be very different from the expectations during Phase 1 testing.
Henry I. Miller, M.D.