Tag: Pharmaceutical companies

Is the Era of Off-Label Promotion Over?

The question arises in the wake of yesterday’s news that the government and GlaxoSmithKline settled a string of lawsuits charging the company with illegal promotion of prescription drugs for unapproved uses. The $3 billion settlement represented just a small fraction of the sales to patients for whom the off-label prescriptions either caused harm or did little or no good.

Glaxo’s chief executive Andrew Witty, in a prepared statement, assured the public that his company has “fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity.”

Judging by the number of seminars and conferences over the past few years designed to help companies meet the legal requirements for promoting drugs, there would certainly appear to be a lot more attention being paid these days to staying within the law. There have been 165 settlements between the government and drug companies over the last two decades, and the more recent settlements — $2.3 billion from Pfizer and $1.4 billion from Eli Lilly — have achieved blockbuster status (a word usually reserved for drug sales above $1 billion). While that is affordable for the highly profitable industry, settlements of that size do tend to capture the attention of top company officials and begin to tip the risk-reward ratio for illegal activity toward better compliance with the letter of the law.

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Part 2: Bypassing Prior Authorizations


A few weeks ago, I saw a young patient who was suffering from an ear infection. It was his fourth visit in eight weeks, as the infection had proven resistant to an escalating series of antibiotics prescribed so far. It was time to bring out a heavier hitter. I prescribed Ciprofloxacin, an antibiotic rarely used in pediatrics, yet effective for some drug-resistant pediatric infections.

The patient was on the state Medicaid insurance and required a so-called prior authorization, or PA, for Ciprofloxacin. Consisting of additional paperwork that physicians are required to fill out before pharmacists can fill prescriptions for certain drugs, PAs boil down to yet another cost-cutting measure implemented by insurers to stand between patients and certain costly drugs.

The PA process usually takes from 48-72 hours, and it’s not infrequent for requests to be denied, even when the physician has demonstrated an undeniable medical need for the drug in question.

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Drugmakers May Win Big in Effort to Curb Gun Violence

Reducing gun violence by increasing access to mental health services may cost billions of taxpayer dollars and give drugmakers that help treat mental illness a revenue windfall. But will it reduce gun violence? The answer is uncertain.

In the wake of the tragic shooting at Sandy Hook Elementary School, there have been repeated calls to increase access to mental health services as a way to reduce gun violence in the U.S., even though the evidence is weak at best that those services actually reduce gun violence.

Absent from these calls to action is any sense of how much that policy would cost. Many argue that any cost is worthwhile if it prevents just one needless death due to gun violence. But we live in austere fiscal times and knowing the price tag before taking action makes sense (click on the image above to enlarge).

A just-published Bloomberg Government Study estimates that the potential impact on the federal deficit due to increased spending on mental health services could exceed $260 billion from 2014 to 2021.

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