by John M. Curtis
(310) 204-8700

Copyright Oct. 6, 2009
All Rights Reserved.

       Filing an unprecedented lawsuit Oct. 2 in federal court, Irvine-based drug maker Allergan Inc.—the maker of Botox—rejected the Food and Drug Administration’s recent ban on marketing off-label drugs   FDA banned drug companies from promoting and  marketing drugs not approved by the FDA.  Pfizer, the world’s biggest drug company, paid $2.3 billion Sept. 2 to settle criminal and civil complaints about inappropriately marketing its painkillers Bextra and Lyrica.  Bextra was yanked from the market because of dangerous side effects.  “It’s another step in the administration’s ongoing effort to prosecute any individual or organization that tries to rip off health care consumers and the federal government,” said Health and Human Service Secretary Kathleen Sebelius.  Allergan’s Oct. 2 lawsuit directly relates to Pfizer’s Sept. 2 settlement, punishing drug industry fraud.

            Allergan’s suit attempts to preempt pending litigation against the drug-maker, concerned that the government action against Pfizer could pave the way to future litigation.  Bristol-Meyers Squibb also suffered a $515 million judgment Sept. 18, 2007 for paying off doctors to prescribe Bristol-Meyers Squibb drugs.  “Kickbacks are especially nefarious when they’re used as a marketing effort to convince physicians to prescribe drugs for uses that the FDA has not determined to be safe and effective,” said U.S. Attorney in Boston Michael Sullivan.  Nothing peddles influence more than hard- green-cash, the exact argument used by Sen. John McCain (R-Ariz.) and Sen. Russell Feingold (D-Wis.) to pass March 22, 2002 campaign finance reform.  Influence peddling reached its peak in the drug business when the New York and LA Times exposed corruption at the National Institutes of Health.

            Consumers considering taking FDA-approved or off-label drug have a right to know whether the safety and efficacy research can be trusted.  When NIH researchers receive salaries from both the government and drug-makers it compromises the integrity of scientific research.  Banning off-label drug use presents problems for companies like Allergan, whose Botox sales are built around off-label applications.  Allergan sells about $1.3 billion annually, perhaps as much as 50% from off-label sales.  Allergan markets Botox as a “natural purified protein” with a “30-plus-year safety record,” reassuring physicians about its long-term safety.  On May 13, the FDA required Allergan to post “black-box” warning labels, warning doctors and patients about Botox’s potential dangers.  While used for many off-label purposes, some question Botox’s safety and effectiveness.

            In September, the FDA required Allergan to implement Risk Evaluation and Mitigation Strategies [REMS], publishing off-label prescribing guidelines for use of Botulinum Toxin, Type A.  Allergan believes that it’s impossible to implement an effective REMS program, while, simultaneously, restricting the drug’s marketing to only FDA approved uses.  Some experts believe over 33% of Allergan’s Botox applications involve off-label uses.  Allergan claims that its ban on off-label marketing violates its First Amendment corporate and individual free speech rights.  Yet every one knows that you can’t cry fire in a crowded theater.  When Allergan Senior Vice President of product development Mitchell F. Brin, M.D. told New York Times in 2003 that Botox  “will go down in history as drugs affecting mankind as similar to the impact of penicillin,” is it any wonder the FDA got nervous?

            Drug makers, of course, have a responsibility to disseminate product information, including research about safety and effectiveness.  Allergan’s recent suit against the FDA alleges the government violates its commercial and general free speech rights.  “The government is allowing drugs to be used off-label but at the same time not allowing companies to proactively provide information about it,” said Douglas Ingram, Allergan’s Executive Vice President and Administrative Officer.  Allergan knows it has no “free speech” right to off-label marketing.   Robert McAllister, former Director of the National Spasmodic Dysphonia Assn., told USA Today in 2003 that Botox was “a godsend” and the “cat’s meow” for treating the “strangled voice.”  McAllister denied that his nonprofit organization, funded almost exclusively by Allergan, recommends any form of treatment for the “strangled voice.”

            Allergan’s recent suit claims the FDA denies its right to free speech and obligation under FDA guidelines to provide Risk Evaluation & Mitigation Strategies [REMS] to inform and protect physicians.  “That doesn’t serve the public health,” said Ingram, complaining that restricting off-label product information endangers the public.  With at least a third of Allergan’s Botox business coming off-label, it’s no wonder that the drug maker has issues with current FDA policy.  If Botox were really the “next penicillin,” as Allergan’s VP of Product Development Dr. Brin claims, the FDA wouldn’t insist on “black box” warning labels.  Exaggerated product claims and excessive off-label applications prompted the FDA to put its foot down.  Allergan knows that they have no First Amendment right to exaggerate product claims, market off-label uses and minimize safety concerns.

.John M. Curtis writes politically neutral commentary analyzing spin in national and global news.  He's editor of OnlineColumnist.com and author of Dodging The Bullet and Operation Charisma.