Pharmaceutical giant Pfizer Inc. has agreed to pay $1 million to the state of Oregon and conduct a national TV ad campaign correcting commercials that overstated the benefits and understated the risks of one of its products, Oregon Attorney General Ellen Rosenblum announced Thursday.
The settlement, filed Thursday 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, she said.
In 2008 and this year, 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.
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.
COMPANY’S SETTLEMENT WITH OREGON DEPARTMENT OF JUSTICE
REGARDING ZMAX AND EPIPEN
Pfizer Inc. reached an agreement with the Oregon Department of Justice (DOJ) to pay $1 million to settle an investigation regarding past promotional practices related to Zmax and EpiPen. The agreement resolves the Oregon DOJ’s allegations that a Zmax brochure, which was in circulation for approximately one year ending in July 2011, and one EpiPen television advertisement, which aired over the course of one week in April 2012, violated previous agreements entered into with the Oregon DOJ. The Zmax brochure was the subject of a June 19, 2012 untitled letter from FDA and the EpiPen television advertisement was the subject of a May 24, 2012 Warning Letter from FDA. As part of the settlement agreement, Pfizer denies any wrongdoing. The safety of Zmax and EpiPen, when used as directed, was not an issue.
“Pfizer is resolving this investigation to avoid the further time and cost of litigation. Pfizer is committed to conducting its business with the highest degree of ethics and integrity and providing patients, physicians and the public with accurate, science-based information regarding our medicines.”
The Company has numerous controls and oversight mechanisms in place to help facilitate compliance with state and federal laws, and continues to evaluate these policies and practices on an ongoing basis. Pfizer’s compliance program includes a dedicated chief compliance officer, corporate compliance committee, code of conduct, extensive compliance training, policies and procedures regarding the appropriate promotion of Pfizer’s products, auditing and monitoring, a compliance hotline and extensive procedures to investigate and remediate potential issues of non-compliance with company policy or applicable legal requirements.