MMM Previews Pharma Debates in DC: Prepare for a Wild Ride in 2012

Dec. 12, 2011 — Facing a need to decrease spending and boost revenues, the federal government will continue to target the pharmaceutical industry in 2012, according to a recent report in the December issue of Medical Marketing & Media. In the report, “Outlook 2012: Detailing DC,” author Matthew Arnold states that although pharma is fighting back, it faces a number of significant challenges and needs “to make the case for itself as a source of good jobs and a center of American innovation.”

The comprehensive report draws heavily from remarks by Coalition Executive Director John Kamp and others at the November meeting of leading members of the Coalition, held in Washington, D.C.  Arnold lists several controversies likely to arise in 2012, including:

  • Proposals to end or limit the tax deductibility of communication and marketing by pharma and other companies
  • Potential imposition of additional discounts (“rebates”) on medicines sold to the government
  • Efforts to reduce patent protection for biologics from 12 years to seven years
  • Possible multiple “riders” to legislation to fund FDA under the PrescriptionDrug User Fee Act V (PDUFA V)
  • Possible guidance from the FDA on social media
  • Rules from HHS’ Centers for Medicare & Medicaid on the Sunshine Act

Arnold suggests that ongoing challenges to the FDA off-label marketing restrictions may provide some regulatory clarity for pharma marketers. “FDA’s policy on off-label uses of approved drugs is being challenged on First Amendment grounds,” says Arnold. Among other issues, many industry lawyers see a “potential disarming of the rationale behind the jaw-dropping settlements for off-label marketing,” Arnold states.

Drawing on Kamp’s November briefing, Arnold notes that with Wall Street now in the public’s crosshairs, the pharma industry is getting less negative attention, and health care marketing is becoming less of a target than medical product safety. “We are still in the post-Vioxx era,” Kamp said in the report. Thus, Members of Congress are less focused on pharma marketing and more focused on food and drug safety, and the proposed new medical device approval process.

Arnold also quotes Kamp’s report, saying that “the best kept secret about healthcare reform is that if it keeps, it’s a pretty good deal for pharma.”