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FDA Illegally Delaying Prescription Drug Information Program

Feb. 6, 2003

FDA Illegally Delaying Prescription Drug Information Program

Public Citizen Asks Court to Order Agency to Follow the Law for Providing Written Information with Filled Prescriptions

WASHINGTON, D.C. – Public Citizen today filed suit against the U.S. Department of Health and Human Services (HHS) because that agency has not allowed the public to comment on new rules regarding patient information leaflets distributed with prescription drugs by pharmacists, relying instead on a faulty private sector program that does not give patients the vital drug safety information they need. This is in violation of a 1996 patient information law passed by Congress, and the court should order the agency to seek public comments, Public Citizen said in its lawsuit filed in the U.S. District Court for the District of Columbia.

In 1995, the Food and Drug Administration, a part of HHS, proposed a rule requiring the distribution of scientifically accurate and useful written information with 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 passed a law in 1996 adopting that timetable and requiring the private sector to design and implement the program.

In that law, Congress provided that if the private sector’s program failed to meet certain quality and quantity standards by 2001, the FDA must then take public comment on alternative methods for providing accurate and useful leaflets to prescription drug consumers. Although the FDA acknowledged in June 2002 that the private sector failed to meet the 2001 goals, the agency nonetheless refuses to take comment on alternative methods of improving the leaflets, in violation of the law.

“Members of Congress acknowledged that patients should be receiving this information, and they set specific deadlines to ensure that the program starts soon and is done well,” said Larry Sasich, Pharm. D., research analyst with Public Citizen’s Health Research Group. “We have been forced to file this lawsuit because the FDA is unwilling to lift a finger to make up for the private sector’s inadequate job.”

According to the FDA’s assessment of the private sector’s information campaign, while 89 percent of patients were receiving information leaflets, the leaflets on average had just half the information considered essential for a patient to take a drug safely. None of the leaflets met the seven quality criteria of the proposed rule.

Public Citizen has an interest in the success of the program because its members, one of whom is named as a co-plaintiff in the lawsuit, are not receiving sufficient information about their prescription drugs, as Congress intended. Also, because the FDA has not established a public comment period, Public Citizen has been denied its right to participate in the process.

The lawsuit asks the Court to declare unlawful the FDA’s delay in opening a comment period and order the agency to immediately seek public input on initiatives that could achieve the goals laid out by the FDA rule and 1996 law.

“The private sector’s performance up to this point is clearly not acceptable. We need to look for other ways of implementing a workable program,” said Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group. “Educating patients about the potential dangers of the medications they are taking is imperative for lowering the number of needless deaths and injuries from unsafe drugs and drug interactions. It’s inexcusable for the FDA to stand in the way of that.”

Click here to view a copy of the complaint.