«“The problem is it’s a classic case of Trump demagoguery. It sounds good — cutting red tape and saving lives — but at the root of it there’s nothing there,” said Peter Lurie, former top official of the Food and Drug Administration, now president of the Center for Science in the Public Interest. “The FDA already had a process that approved more than 90 percent of people who wanted access to these drugs and treatments.”
The measure was originally pitched by a Phoenix-based libertarian think tank called the Goldwater Institute as a way to give terminally ill patients access to unapproved medications from pharmaceutical companies without being bogged down by FDA regulations. But since at least the 1970s, there had already been a way for patients to get access to such drugs. That pathway — called expanded use or compassionate use — is used by hundreds of people a year, and more than 90 percent of such requests are granted by the FDA, experts say.
When seriously ill patients struggle to access unapproved drugs outside clinical trials, drug companies, not the FDA, are most often the main obstacle. But the law did not address that.»