Consumer Activists Demand Mandatory Medication Innovation

Patient advocates recently surprised pharmacists and manufacturers by convincing an FDA advisory panel to recommend increased government scrutiny of its voluntary patient information policy. FDA's Drug Safety and Risk Management Advisory Committee met in July to review the status of a private sector initiative for distributing medication information to patients obtaining prescriptions in pharmacies. An analysis of the program by National Association of Boards of Pharmacy researchers found that 89 percent of patients receive written information-well exceeding the goal of distributing information to 75 percent of consumers. But the analysts also concluded that much of that information failed to meet criteria for usefulness. The patient handouts rated fairly high for being scientifically accurate, up-to-date, and nonpromotional but much lower for legibility-as determined by print size, quality, and ease of reading.

Pharmacy organization representatives and pharmaceutical safety experts complained that the analysts set the bar too high in rating "usefulness" and that they measured criteria never included in a 1996 action plan. Pharmacists strongly oppose federal standards for patient information, particularly in a market in which medicine is increasingly customized to fit individual patients' needs.

But patient advocates led by representatives from Public Citizen's Health Research Group insisted that the private sector had failed to meet patient information goals, terming industry's record "appalling and disgraceful." The advisory panel stopped short of recommending a mandatory information program but advised FDA to take a more active stance in compelling pharma companies to improve the quality of patient information. The committee recommended that FDA form a group to develop a new action plan and enforcement strategy that would ensure private sector compliance with information standards by 2006.

The panel also backed establishing a public regulatory body to rate consumer medication information and enforce requirements. Although FDA doesn't have to follow advisory panel recommendations, it often does. Either way, the recommendation is sure to raise pharma companies' awareness of the problem.