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Patient Information Program is Failing Under Private Sector Management

July 31, 2003

Patient Information Program is Failing Under Private Sector Management

New Research Shows Inadequacy of Leaflets; FDA Should Ensure Accuracy and Usefulness, Public Citizen Tells Panel

WASHINGTON, D.C. – Patients are receiving incomplete and potentially misleading information because of the government’s reliance on the private sector to implement a prescription drug information program. The U.S. Food and Drug Administration (FDA) currently allows the private sector to dictate the content of the information patients receive at the time that prescriptions are filled.

The FDA should instead regulate patient information leaflets as a safer alternative to the failing voluntary private-sector program, Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group, said at an FDA hearing today.

In 1995, the FDA proposed a rule requiring the distribution of scientifically accurate and useful written information with all new and refill prescriptions, such as information about adverse effects and guidance on how to best use the drugs. The FDA set a goal: By 2000, 75 percent of patients would be receiving patient information leaflets, and by 2006, 95 percent would be receiving them. Congress’ 1996 law adopted that timetable and required the private sector to design and implement the program, and that the FDA accept public comments on alternative programs if the private-sector program was not working.

A new survey by Public Citizen shows that the private-sector program is not meeting the FDA’s goal or the expectations of Congress, Public Citizen told the FDA today. The survey of the quality of information accompanying 23 top-selling drugs in 2002 that are required to carry black box warnings found that none of the patient drug information leaflets being distributed in a Washington, D.C., pharmacy complied with the 1996 law’s guidelines. These results are extremely troubling because black box warnings are the most serious type of warning the FDA can require.

Further, information included in the leaflets, which had been downloaded from the National Institutes of Health’s MEDLINEplus Web site, was incomplete and inaccurate. It is irresponsible for the site to feature unregulated information that fails to meet minimum quality standards and the information should be removed from the site, Wolfe said.

Although 89 percent of consumers are receiving some sort of information, a study conducted by the University of Wisconsin for the FDA found that none of approximately 1,300 leaflets studied for four common drugs achieved minimum goals for useful, scientifically accurate drug information. As measured by eight objective criteria, the overall usefulness of information was about 50 percent.

“The notion that consumer drug information can be 50 percent useful is unfathomable,” Wolfe said in his testimony to the FDA. “Drug information that communicates only half of what it should is misleading, and misleading drug information is potentially dangerous.”

Public Citizen filed suit against the U.S. Department of Health and Human Services (HHS) in February of this year because the FDA was refusing to hold a hearing on the matter. HHS signed a settlement agreement in April, agreeing to hold today’s hearing.

The hearing should be the agency’s first step in the process that will culminate in FDA regulation of the leaflets. A 1999 rule gave the FDA authority to regulate information distributed with certain drugs; a minor modification of the rule could extend that authority to all drugs. The already widespread distribution of substandard information means that it would be no more expensive to distribute information that would help patients.

“The research has been done and the history is clear,” Wolfe told the panel. “There is no longer any legitimate argument in continuing to consider voluntary private-sector programs as a solution for providing consumers with useful, scientifically accurate written drug information. This is a failed paradigm.”

To view a copy of Public Citizen’s statement to the FDA panel, click here.