Industry Tries to Revamp Drug Marketing Amid FDA Scrutiny

Strategic Insights -

The pharmaceutical industry is undergoing a shift in marketing practices, driven by regulatory pressure and public concern over medication safety. The Pharmaceutical Research and Manufacturers of America (PhRMA), the industry's chief trade association, is developing new guidelines for television and other consumer ads, while lawmakers are pushing for legislation requiring companies to submit ads for review before release. However, critics argue that voluntary guidelines may not be effective in curbing problematic practices, and that a law requiring pre-submission may be vulnerable to First Amendment challenges.

Key Takeaways:

  • The Pharmaceutical Research and Manufacturers of America (PhRMA) is developing voluntary guidelines for drug companies to follow for TV and other consumer ads.
  • Legislation proposed by Sens. Chuck Grassley (R-Iowa) and Christopher Dodd (D-Conn.) would require companies to submit ads and other promotional materials to the FDA for review 30 days before release.
  • Companies such as Pfizer and Johnson & Johnson are reorienting their consumer ads to highlight risks and benefits, with Johnson's ad for Ortho Evra featuring a doctor cautioning a young woman about risks.
  • Critics like Rob Schneider of Consumers Union fear that industry-led initiatives may be ineffective in preventing deceptive practices, and warn that practices will resurface when regulatory focus subsides.
  • Industry representative Billy Tauzin suggests ads should be carefully directed to narrow audiences, be more informative about diseases, and better balanced about risks and benefits.
  • A law requiring pre-submission would be "highly vulnerable" to a First Amendment challenge, according to Daniel Troy, a former FDA general counsel.

Statistics:

  • 99%: The effectiveness of Johnson's Ortho Evra birth-control patch, as highlighted in their TV ad.
  • 30 days: The proposed review period for ads and other promotional materials under the lawmakers' legislation.
  • Several years ago: The time period when PhRMA tried but failed to craft voluntary guidelines.

Sources:

  • "Pharmaceutical Research and Manufacturers of America" (PhRMA)
  • "The Wall Street Journal" (no specific date provided)
  • Julie Schmit, The Associated Press (no specific date provided)