Is an extra profit really worth jeopardizing the health of thousands of American consumers?
Generally, this blog focuses on the greed of the financial sector, but today I would like to shed light on the misconduct of a major pharmaceutical company. Companies like Pfizer have been putting profits over compliance to the detriment of society for years.
Pfizer was recently fined $1.19 billion in criminal penalties for the off-label marketing of Bextra. After rigorous testing, the FDA approved this drug for the sole purpose of easing arthritis pain and menstrual cramps. However, Pfizer employees, hungry for an extra profit, illegally marketed Bextra to doctors as a cure for all types of pain. This is referred to as “off-label marketing” and is illegal in most countries. In the United States, Federal Law prohibits pharmaceutical companies to market a drug to doctors or consumers for purposes other than those approved by the FDA and delineated on the drug’s label. According to Bloomberg, Pfizer also paid $1 billion in civil penalties relating to Bextra and two other drugs on the same day.
OVER $2 BILLION IN ONE DAY! WHY SO MUCH?
Simply: Marketing off-label uses of drugs is almost always illegal.
I’m sure many of you are thinking, “I’ve had my doctor prescribe a drug meant for one illness in order to cure the symptoms of another.” Don’t worry; this is a common and legal practice under the Food, Drug, and Cosmetic Act. It can be a tricky legal matter, but the law permits doctors to prescribe a drug for any purpose that they deem safe and reasonable. Off-label prescription is particularly common in pediatric medicine. In fact, in an October 22nd interview on NPR, Dr. Sydney Spiesel claimed that between 50% and 70% of all medications used by pediatricians are off-label but useful. Doctors learn about the off-label uses of drugs through medical journals and independent lab testing. Most drugs that are prescribed off-label are older and have been proven for other uses through extensive research and use.
So, why $2 billion in one day? Pfizer’s crime was marketing Bextra and other drugs to physicians without solicitation and for uses other than those approved by the FDA. In short, off-label prescription by doctors is fine, but off-label marketing by pharmaceutical companies is expressly forbidden. Prohibition of off-label marketing was upheld by the Supreme Court in USA v. Z Cosmetica U.S.C. 21 §§301-97. Any reasonable reader can see that overzealous marketing of off-label uses of pharmaceuticals would lead to a country flooded with “wonder drugs” – not a safe place if you ask me.
In its “Who We Are” portion of its website, Pfizer claims that it “believes that patients benefit from information about diseases and medical treatment options” and that “In order for patients to make good decisions about their health, they need access to health information.” This is an excellent policy, but while it recognizes the importance of access to information, Pfizer has shamefully ignored FDA regulations in attempts to supply its own version of the pertinent facts to doctors and consumers.
Pfizer and other companies need profits as incentives to work quickly and efficiently, but putting profits over compliance and ethics should be strongly discouraged. Compliance in the world of pharmaceuticals translates to public health and safety. Is an extra profit really worth jeopardizing the health of thousands of American consumers? Hopefully the pain of the most recent fines will steer Pfizer’s shareholders and board members toward the right answer.
Assisted by Zach Kady