By Paul Howard and Jim Copland
From 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.
Fortunately, there is hope on the horizon.
On Dec. 3, the U.S. Court of Appeals for the Second Circuit issued a landmark ruling in United States v. Caronia, overturning the federal prosecution of a drug company sales representative who had disseminated information about an off-label use of a drug.
The court ruled that "criminalizing the truthful off-label promotion of FDA-approved prescription drugs" was an unconstitutional limitation on free speech in violation of the First Amendment.
The Caronia case highlights two major emerging trends in medicine and law: the widespread prescription of FDA-approved medications for off-label uses and the increasing application of federal criminal law to regulate pharmaceutical promotion.
However the Supreme Court decides the First Amendment question in Caronia, the FDA needs to rethink its off-label speech regulations, which have become overly broad and unnecessarily opaque, effectively criminalizing truthful science-based speech by some parties, but not others.
Doctors often lack adequate information about off-label drug use because those best-positioned to inform them about the benefits and risks associated with such uses -- the drug manufacturers themselves -- are often precluded from doing so by the FDA.
The FDA's official line is companies can share only "scientific" information, not "promotional" information -- a murky distinction at best.
Under the FDA's current rules, companies can communicate scientific information on their medicines by distributing independent articles from medical journals. But since companies sponsor the lion's share of all drug research, much of the relevant literature is disqualified a priori. And even those articles that make the cut may be months or years behind the latest research.