Pharmaceutical giant Pfizer Inc. has agreed to pay $1 million to the state of Oregon and conduct a national television ad campaign correcting commercials that overstated the benefits and understated the risks of one of its products, Oregon Attorney General Ellen Rosenblum announced today.
The settlement, filed today in Marion County Circuit Court, marks the first time a state Attorney General has obtained payment of a penalty by a major drug company for allegedly violating the terms of an earlier consumer protection legal settlement between the parties.
In 2008 and 2012, the Oregon Department of Justice obtained a judgment and an assurance of voluntary compliance against Pfizer.
“Companies need to know when they agree to terms as part of a legal settlement, the Department of Justice intends to hold them to their promise to Oregonians,” said Attorney General Rosenblum.
Last May, the U.S. Food and Drug Administration issued a warning letter to Pfizer regarding allegedly misleading ads for EpiPen, the company’s injectable form of epinephrine. A month later, in a separate incident, the FDA alleged a Pfizer brochure for its antibiotic Zmax “minimized important risk information” and made misleading claims.
The Oregon Department of Justice claims the allegedly deceptive EpiPen and Zmax advertising violated the state’s earlier settlements with Pfizer.
The corrective advertisements for EpiPen, also required by the FDA, will be broadcast on national cable and broadcast television networks starting this week.
In addition to the monetary payment and corrective advertising, the assurance of voluntary compliance filed today in Marion County has the following additional requirements:
Zmax direct-to-consumer advertising in any medium shall clearly and conspicuously disclose: “Zmax does not work against infections caused by viruses or the flu. Only your doctor can determine whether an antibiotic is indicated.”
Restrictions on promotional use of patient survey data and promotional claims about patient preference.
An extension of the requirement in the 2008 judgment that Pfizer submit prescription drug television advertisements to the FDA and wait at least 45 days before running the ads. If the FDA does not pre-approve the advertisement, Pfizer must provide the Oregon Attorney General with a copy of the commercial for its approval.
An additional $1 million payment that is suspended so long as Pfizer complies with the 45-day delay provision.
The Department of Justice has in recent years vigorously pursued a series of actions against some of the nation’s largest pharmaceutical companies. The department has recovered more than $16.5 million in consumer protection settlements from drug and medical product companies in the last 12 months alone.
In addition to paying financial penalties, the companies in many of these settlements also agreed to certain terms governing their ongoing business practices.
Attorney General Rosenblum thanked David Hart, assistant attorney-in-charge of the Financial Fraud/Consumer Protection Section, as well as Michael Kron, assistant attorney general, for their work on this case.
Jeff D. Manning, firstname.lastname@example.org, 503-378-6002