Manhattan Institute's Paul Howard, director of the Center for Medical Progress, and Jim Copland, director of the Center for Legal Policy, joined forces to author an article on the federal government's criminal prosecution of truthful speech about off-label pharmaceuticals.
The piece can be found in today's Investor's Business Daily:
Every day, millions of Americans benefit from drugs their physicians prescribed for uses and indications beyond those listed on the drug's FDA-approved label.
Some of these off-label uses include treatment for diseases or symptoms, or patient population (like children), not formally reviewed by the Food and Drug Administration. Off-label drug prescribing has been a boon to public health and continues to grow.
A 2006 study in the Archives of Internal Medicine estimates that 21% of commonly used drugs are prescribed for off-label uses.
Doctors find off-label drugs particularly valuable in life-threatening emergencies: 36% of all drugs used in intensive care units are for off-label indications, according to a 2011 study in the Journal of Critical Care. Off-label prescriptions of anti-psychotic drugs alone amounted to an estimated $6 billion in 2008.
Yet Americans may be missing out on new applications for drugs because the law makes it difficult for pharmaceutical companies to share this information with physicians.