Pfizer Chair and CEO Hank McKinnell Supports FDA Review of Prescription Drug Advertisements
Pfizer Chair and CEO Hank McKinnell on Tuesday said the company supports a proposal in Congress that would require pharmaceutical companies to submit all advertising to FDA for advance review, the Boston Globe reports (Henderson, Boston Globe, 5/18).
Introduced in April by Senate Finance Committee Chair Chuck Grassley (R-Iowa) and Sen. Christopher Dodd (D-Conn.), the bill would require pharmaceutical companies to seek approval from a new Center for Postmarket Drug Evaluation and Research for advertisements for new prescription drugs, high-risk medications and treatments not tested in post-market clinical trials (California Healthline, 4/28).
McKinnell said that the company works to comply with FDA advertising rules, but "[s]ometimes, we get it wrong. We certainly can submit everything before we run it. And if they don't like it, they ought to tell us before we run it, rather than after." He noted that advertisements do a "great job" of promoting brands but fail to adequately convey medication risks.
However, McKinnell was "less receptive" to other provisions in drug-safety legislation in Congress, including the creation of an independent drug-safety center at FDA, the Globe reports. McKinnell said such a center would create "a giant game of gotcha" between FDA departments.
Meanwhile, he also said he opposes a bill that would require the publication of early trials, noting that doing so could raise false hopes for patients who view unconfirmed studies. He added that a promise from FDA to provide information to the public about drug risks as they become available could scare people unnecessarily.
According to the Globe, Pfizer has stopped most advertising while company officials develop campaigns that better inform patients about drug risks, their diseases and the need to talk to physicians about treatment (Boston Globe, 5/18).
In related news, Verispan recently reported that Pfizer's COX-2 inhibitor Celebrex has taken over 34% of the market share for the company's Bextra, which was removed from the market in April at the request of FDA. FDA expressed concerns that Bextra could increase the risk for heart disease and skin problems.
For the week ending May 6, Celebrex's total prescriptions were 228,898, and new prescriptions reached 92,674, the drug's "best showing in at least three months," according to the AP/Los Angeles Times. Analysts said the figures were "a glimmer of good news" for Pfizer, but they added that the Celebrex's "glory days ... were firmly behind it" as more doctors shift patients to other prescription drugs or over-the-counter medications, the AP/Times reports.
Meanwhile, Mobic, a pain reliever marketed by Boehringer Ingelheim and Abbott Laboratories, has taken about 26% of the Bextra market (AP/Los Angeles Times, 5/18).