Drugmakers Test the Waters of the World Wide Web

Strategic Insights -

Pharmaceutical companies are increasingly turning to the internet to promote their prescription drugs, despite a lack of clear regulatory guidelines from the FDA. Upjohn Co. launched a website for Rogaine (minoxidil) in June, offering customers a list of recommended physicians and a $10-off coupon for a doctor's visit. Schering-Plough soon followed with a website for Claritin (loratidine), a non-sedating antihistamine. The websites include lists of recommended physicians and coupons for discounts, but also raise important questions about the regulation of prescription drug promotion on the internet.

Key Takeaways:

  • The FDA has yet to issue clear regulatory guidelines for the promotion of prescription drugs on the internet, leaving pharmaceutical companies in a regulatory vacuum.
  • Upjohn Co. and Schering-Plough are among the first companies to promote prescription drugs on the web, with their websites offering lists of recommended physicians and coupons for discounts.
  • The FDA considers promotion on the web to be a form of "labeling" or "advertising", depending on the context, with different sets of rules applying to each.
  • Companies are reluctant to market prescription products on the internet due to a lack of regulatory guidance, and concerns about the potential risks and liabilities associated with online promotion.
  • The internet raises new challenges for FDA regulation, including the difficulty of knowing who has access to a website and the potential for international firms to circumvent US regulations.

Statistics:

  • The Upjohn Co. website for Rogaine (minoxidil) includes a list of recommended physicians and a $10-off coupon for a doctor's visit.
  • Schering-Plough's website for Claritin (loratidine) includes a list of recommended physicians and a $5 rebate.
  • It costs between $50,000 to $150,000 to set up an attractive and highly functional internet website, with recurring costs to maintain and update.
  • The FDA receives 10,000 to 20,000 comments per year on new and existing regulations, and has jurisdiction only in the United States.

Sources:

  • "FDA Warns Advertising on the Internet Raises Regulatory Issues" by the Associated Press, without date.
  • "Regulation of Internet Advertising of Prescription Drugs" by the Food and Drug Administration, without date.
  • "FDA Says Internet is Redefining the Industry" by Wendy Bortw Johnson, President of Com-Med Interactive, Deerfield, Ill., testimony to the FDA hearing on direct-to-consumer advertising.