Relaxing Rules for Off-Label Prescribing: "Akin to Crying 'Fire!' in a Crowded Theater?"

In the Amarin court case, the court ruled that the company has the right, under the First Amendment, to promote information to health-care professionals about certain uses of the drug Vascepa that aren't covered by the drug's FDA-approved labeling -- as long as the information is true and not misleading (read "Amarin Wins Off-Label Case Against FDA"). This case is likely to influence new guidance from the FDA regarding off-label drug promotion by pharma marketers.

"Might changes in rules for promotion of off-label indications based on free speech arguments lead to a situation akin to crying fire in a crowded theater?," asks authors of Commentary published in the recent issue of JAMA Internal Medicine. The authors of the commentary -- Chester B. Good, M.D., M.P.H., and Walid F. Gellad, M.D., M.P.H., of the Veterans Affairs Pittsburgh Heathcare System -- referred to "compelling evidence" that "off-label prescribing is frequently inappropriate and that prescribing in these circumstances increases the risk for an adverse event substantially."

That evidence was presented in a study published in the same issue of the journal titled "Off-label Prescription Drug Use and Adverse Drug Events" (JAMA Intern Med. Published online November 2, 2015. doi:10.1001/jamainternmed.2015.6058).

What is the "compelling evidence?"

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Ethical Off-Label Drug Promotion: What Would It Look Like?

In a Forbes piece (here), former Pfizer VP of Research John LaMattina noted the "jarring" juxtaposition of two articles in the August 8th edition of the New York Times.

One article was the obituary of Dr. Frances Oldham Kelsey (see image on left, read Frances Oldham Kelsey, F.D.A. Stickler Who Saved U.S. Babies From Thalidomide, Dies at 101), a "legend for anyone involved in regulation and approval of new drugs."

The other was an article about a court ruling opening the door for pharma to promote their new (and old) drugs off-label (read Amarin Wins Off-Label Case Against FDA; Will Promote Viscera Off Label "ASAP").

You recall that thalidomide was already on the market in Europe as a sleeping aid, when the drug company Merrill submitted it for approval to market in the U.S. by the FDA.

Dr. Kelsey felt that there was insufficient safety data to justify U.S. approval. "Much to Merrill's dismay," notes LaMattina, "Dr. Kelsey was adamant that more testing was needed and refused to recommend approval of the drug. This delay proved to be more than justified."

Jump ahead more than 50 years to the off-label court case. What does the thalidomide experience teach us about off-label promotion?

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Off-Label Uses Promoted in DTC Ads for Diabetes Drugs

Print and TV DTC ad for Farxiga
(click on image for an enlarged view)

Public Citizen, a consumer advocacy group with more than 350,000 members and supporters nationwide, sent FDA’s OPDP Director Tom Abrams a letter on March 31, 2015, urging him “to stop the apparently violative off-label promotional statements in the direct-to-consumer (DTC) advertisements of five prescription drugs approved for the treatment of Type 2 diabetes. The drugs are Farxiga (dapagliflozin), Jardiance (empagliflozin), Invokana (canagliflozin), Victoza (liraglutide) and Bydureon (extended-release eventide).”

Usually, pharmaceutical companies are accused of promoting drugs “off-label” to physicians, which is understandable because it is perfectly legal for physicians to prescribe drugs for so-called off-label use.

The FDA rarely cites off-label or “unapproved use” claims made in DTC ads. None of the letters issued by FDA in 2014 mentioned that violation. Historically (between 2004 and 2013), only 4% of violations cited in FDA letters were concerned with off-label/unapproved use promotion and no TV ad received such a letter (see here).

Public Citizen includes a Farxiga ad that “touts” weight loss and blood pressure reduction as potential benefits although the drug has not been approved for those indications (see the ad in the above figure; also included is a screen from the TV ad).

“These five drugs have been approved solely to lower hemoglobin A1C levels in patients with Type 2 diabetes,” says Public Citizen, “but the advertisements presented in this letter clearly convey the false perception to patients and doctors that the drugs have been deemed safe and effective for weight loss and/or reducing blood pressure.”

Public Citizen wonders if the FDA approved the ads and asks a couple of interesting questions in light of the recent paucity of warning letters issued by the FDA (read “Banging Year for Drug Approvals, Wimpy Year for Enforcement Actions”).

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Some “Walter White” Pharma Sales Reps Make an “Ungodly” Amount of Money

Last Week Tonight with John Oliver is back on HBO and the pharmaceutical industry was the centerpiece of last night's show in which Oliver spent more than 17 minutes educating the audience on the industry's marketing practices.

Oliver began by citing some statistics such as annual sales of Rx drugs in America amount to over $1,000 per person. "Walter White could have made more money cooking up arthritis medications," quipped Oliver.

I'm not sure arthritis is where the real pharma money is these days -- maybe orphan drugs (see here and here) or cancer drugs (see here), certainly Hep C drugs (see here) are where the real money is.

Oliver focuses mostly on physician marketing and pharma sales reps. He begins by showing segments from direct-to-consumer (DTC) ads, all of which end with the phrase "ask your doctor," which of course is often the butt of jokes (see, for example, here).

"Oliver says Big Pharma wants you to talk to your doctor," says Time, "because they have spent billions of dollars marketing their drugs to physicians. Oliver’s research revealed that pharmaceutical companies spent $24 billion marketing directly to doctors last year. According to one study quoted by Oliver, 9 out of 10 top drugmakers spent more on marketing drugs than researching the drugs. In Oliver’s words, 'Drug companies are like high school boyfriends: they are more interested in getting inside you than in being effective once they are there.'"

I've written about many of the issues that Oliver speaks about in his segment and I will provide the back stories below. There was one thing in this segment, however, that stood out for me. It was a claim made by a GSK executive in a 2001 Advair launch video that the Department of Justice uploaded to its website as part of a whistleblower suit.

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