"The summer of 2015 could mark the beginning of a step back to the pre-1960s era for prescription drugs," warns Jerry Avorn M.D., Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, referencing the thalidomide tragedy of that era that prompted Congress to give the FDA new authority over regulating prescription drugs.
This summer, the FDA will hold a public meeting to discuss whether its restrictions on what drug manufacturers can claim about their products improperly infringes the freedom of those companies. Under current rules, physicians are allowed to prescribe medicines for any condition they want, regardless of what the drug is approved to treat.
However, drug companies are not allowed to promote their drugs for uses that have not been approved by the FDA. In a commentary published in Annals of Internal Medicine, Dr. Avorn suggests that lifting restrictions on marketing drugs for off-label use threatens the liberty of Americans who trust that medications prescribed to them have been properly studied and are proven reasonably safe and effective. He uses the marketing of dietary supplements as an example of the kind of "ludicrous" claims that could be expected if off-label marketing is not restricted.