In my column this week for Hoover’s Defining Ideas, I argue that the FDA is not only standing between sick patients and crucial drugs, it is violating the prohibition against free speech. The problem is its policy about the off-label promotion of drugs.
Between 25 and 60 percent of drugs are prescribed for off-label uses. For cancer patients, that number may be as high as 65 percent. The bottom line is that these drugs help sick patients recover and they save lives. Yet, the FDA criminally prosecutes drug companies that promote and publicize any off-label uses of drugs. If the off-label uses are indeed beneficial, anything that slows down their dissemination could mean the difference between disease or recovery—life or death—in thousands of sick individuals. The unbounded power of the FDA to block the use of such drugs does not square with any defensible conception of individual autonomy or freedom of speech. The FDA is vulnerable. The Supreme Court should cut it down to size.
I elaborate on these issues and more over at Defining Ideas.