Pfizer has agreed to pay nearly $35 million to settle charges for inappropriate marketing of the human growth hormone Genotropin.
The firm acquired the treatment as part of its $60 billion purchase in 2003 of Pharmacia, which the US Department of Justice has been investigating for past off-label marketing of Genotropin (somatropin). The case, which refers to sales practices before the Pfizer acquisition, refers to two Pharmacia subsidiaries, the first of which is to plead guilty to a single count of offering a vendor payment in 2000 for recommending the purchase of the firm’s medicines. A fine of $19.7 million has been levied and the subsidiary will be disqualified from participation in US government healthcare programmes, although the plea will not affect continued marketing of the growth hormone, Pfizer said.
Another Pharmacia subsidiary has entered into a deferred prosecution agreement with the Justice Department that involves a fine of $15 million for improper promotion of Genotropin that Pfizer discovered soon after the Pharmacia merger. No criminal charges will be filed against Pharmacia in exchange for compliance with terms of the agreement, it was noted.
Allen Waxman, Pfizer’s senior vice president and general counsel, noted that the firm “voluntarily and fully self-disclosed the off-label promotion of Genotropin” and Pfizer's marketing and promotion strategies are not involved in the settlement as it has “internal controls to guard against these types of practices."
Pfizer resumes TV ads for Celebrex
Pfizer also added that it has resumed television advertising for its COX-2 inhibitor Celebrex (celecoxib) in the USA, three years after the company suspended direct-to-consumer advertising for drug at the request of the US Food and Drug Administration, after data suggested that it was associated with an increase in cardiovascular risk at high doses.
The two-and-a-half minute TV ad, which was approved by the FDA, will begin by discussing the drug's risks, stating that "any prescription [non-steroidal anti-inflammatory drug], including Celebrex, may increase the chance of heart attack or stroke, which can lead to death." Pfizer noted that it has decided to resume advertising Celebrex after internal research showed that 40% of consumers believed the drug was no longer on the market and that there was much confusion regarding the safety of COX-2 inhibitors.