Pharma fighting back in Washington

Call it the backlash against the backlash. In the wake of the recent Vytorin [1] and Vioxx marketing scandals, drugmakers are banding together to prevent a Congressional crackdown on their power to promote. Ten companies, including Pfizer, Bayer, AstraZeneca, and Johnson & Johnson, have formed a coalition to push for looser restrictions on off-label marketing, previously proposed by the FDA. Drug marketers also want to fight any proposed limits on DTC ads, including a new proposal to require the FDA's phone number in every ad [2]. "We have to be concerned that Congress will act too quickly in this atmosphere," one marketing-strategy firm told the Wall Street Journal.

The Big Pharma coalition--which also includes the National Alliance on Mental Illness and the National Organization for Rare Disorders--will submit their arguments for new off-label promotion guidelines to the FDA today. You'll recall that the FDA wants to allow drugmakers to distribute journal articles that support unapproved uses for their drugs. Advocates say the practice educates physicians about new ways to treat difficult illnesses.

The atmosphere in the capital isn't altogether friendly, though. Several congressional investigations of drugmakers are underway, and Rep. John Dingell, chair of the House Committee on Energy and Commerce, plans to call hearings on DTC ads in a few weeks. "Drug companies should know that they will be held accountable," he said in a statement.

- read the WSJ article [3]

ALSO: Two Harvard doctors are balking at the idea of banning any drugmakers' gifts to docs in Massachusetts; in a Boston Herald column, the physicians argue that the bill goes too far and would interrupt communication. One blogger notes, however, that the doctors misrepresent the provisions in the bill, and the WSJ points out that one of physicians is a director at Pfizer. Report [4] | Report [5] | Column [6]

Related Articles:
Grand jury probes Vioxx marketing. Off-label report [7]
Rep decries off-label marketing "loophole." Report [8]
Ex-Pfizerite indicted in off-label case. Pfizer report [9]
Should FDA's info be in all DTC ads? FDA report [2]
Survey: No doubt DTC ads work. DTC report [10]
Watchdogs circling DTC drug commercials. DTC report [11]