Pfizer Inc. will pay $55 million plus interest to resolve allegations that Wyeth illegally introduced and caused the introduction into interstate commerce of Protonix, a misbranded drug. Protonix is a proton pump inhibitor (PPI) that was used by physicians to treat various forms of gastro-esophageal reflux disease (GERD). This is just another example of a drug company violating the law, paying a settlement and then continuing to do business as usual.
Wyeth sought and obtained approval from the Food and Drug Administration to promote Protonix for short-term treatment of erosive esophagitis — a condition associated with GERD that can only be diagnosed with an invasive endoscope. But federal officials alleged that Wyeth fully intended to, and did, promote Protonix for all forms of GERD, including symptomatic GERD, which is far more common and could be diagnosed without an endoscopy. As all of our readers should now know, under federal law, manufacturers must obtain FDA approval for any indication for use for which a manufacturer intends to market a drug.
A drug is misbranded if its labeling does not contain adequate directions for use by a layperson safely and for the purposes for which it is intended. A prescription drug must be prescribed by a physician and is only exempt from the adequate directions for use requirement if a number of conditions are met, including that the manufacturer only intended to sell that drug for an FDA-approved use. A prescription drug marketed for unapproved off-label uses does not qualify for the exemption and is misbranded.
The FDA warned Wyeth before the company even began promoting Protonix that its proposed promotional materials were misleading. Wyeth had “overstated” its “erosive esophagitis indication” by “suggesting that Protonix is safe and effective in the treatment of patients with . . . GERD, according to the FDA. ” Wyeth was also warned that “Protonix is not indicated for treatment of GERD symptoms that occur in the absence of esophageal erosions.” Despite the FDA’s admonishment, the government alleges that Wyeth trained its sales force to promote Protonix for all forms of GERD, beyond its limited erosive esophagitis indication. It’s also alleged that Wyeth sales representatives frequently promoted Protonix to physicians for unapproved uses, such as symptomatic GERD.
Wyeth promoted Protonix as the “best PPI for nighttime heartburn,” even though there was never any clinical evidence that Protonix was more effective than any other PPI for nighttime heartburn. It’s alleged in the complaint that this superiority slogan was formulated at the highest levels of the company. Wyeth allegedly retained an outside market research firm, at the cost of tens of thousands of dollars, to ensure that sales representatives delivered that misleading superiority message.
Wyeth used continuing medical education (CME) programs to promote Protonix for unapproved uses. CME programs are sponsored by accredited independent providers, such as universities, nonprofit organizations, or specialty societies. Pharmaceutical companies are permitted to provide financial support for CME programs, but they are not permitted to use CME programs as promotional vehicles for off-label indications. It was alleged in the complaint that Wyeth spent millions of dollars providing “unrestricted educational grants” to CME providers, and these grants invariably included promises that Wyeth would not attempt to influence the content of the program in any way.
The government alleges further that one of Wyeth’s “core marketing tactics” for Protonix was to use CME programs “to drive off-label use of the drug.” According to the complaint, the Protonix “brand team” influenced virtually every aspect of these CME programs: program topics, speaker selection, organization, and content. In addition, Wyeth even insisted that the CME program materials use the same color and appearance as Protonix promotional materials–a tactic that Wyeth and the vendor called “branducation.”
It’s high time for the government to clamp down on the politically powerful drug industry. That will require action by both the Executive and Legislative branches of government, including the FDA. The Judicial branch – when allowed to do so – is has been doing its part. Big Pharma must be made to realize that laws, rules and regulation that apply to and govern them must be adhered to. When a company fails to do so, it must pay the consequences.
Source: Corporate Crime Reporter
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