Why Does FDA Keep Drugmakers From Informing Doctors?
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.
The lack of clarity creates a liability minefield for companies. Claims of illicit off-label drug promotion have been among the most commonly asserted Medicaid-fraud allegations in federal enforcement actions.
Manufacturers can’t afford to fight a criminal investigation, because the potential repercussions for a company convicted of a crime include debarment from federal contracting — precluding the company from being reimbursed by Medicare or Medicaid, effectively a corporate death sentence for a pharmaceutical manufacturer.
Rather than risk a criminal trial for off-label drug promotion, pharmaceutical companies are increasingly entering into nonprosecution agreements with the Justice Department and U.S. Attorneys’ offices and corporate integrity agreements with the Health and Human Services Department to avoid prosecution.
Such agreements involve significant fines (sometimes in the billions of dollars), significantly modified business practices (sometimes overseen by corporate monitors who report to a federal prosecutor) and even the removal of top executives.
In 2012, Abbott Laboratories paid a $1.6 billion fine and pleaded guilty to a criminal misdemeanor for the off-label promotion of the anti-convulsant epilepsy drug Valproic Acid (Depakote) for schizophrenia, bipolar disorder and migraines — notwithstanding that such uses are well-established standards of care in the medical community approved for reimbursement by the federal government and private insurers. Instead of its patchwork of current rules, the FDA should adopt a safe harbor to let drug companies communicate truthful science-based off-label information (including risks and benefits) about their products to the physician community.
Physicians are highly sophisticated, and a supplemental warning accompanying such information, emphasizing that the use in question is not FDA-approved and that safety and efficacy information is still emerging, should give physicians enough information to make informed decisions.
Something has to change, because patients are the losers in a system that limits companies’ ability to communicate with doctors about the latest advances in medicine. We shouldn’t be telling companies to shut up when what they have to say can save lives.
Let’s hope Congress and the FDA — and the Supreme Court, when it takes up Caronia — get the message soon.
This piece originally appeared in Investor's Business Daily
This piece originally appeared in Investor's Business Daily
