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Government Agrees to Follow Law, Take Steps Toward Useful Patient Drug Information Program

April 7, 2003

Government Agrees to Follow Law, Take Steps Toward Useful Patient Drug Information Program

Settlement in Lawsuit Filed by Public Citizen Will Ensure That Public Can Have Input in Alternatives to Failing Private-Sector Leaflet Program

WASHINGTON, D.C. – Agreeing to the terms of a lawsuit filed by the public interest group Public Citizen in February of this year, the U.S. Department of Health and Human Services (HHS) on Friday signed a settlement under which it will open for public comment a process intended to provide patients with useful information with all new and refill prescriptions. The department had been relying on a faulty, voluntary, private-sector program that did not meet the requirements of a 1996 law passed by Congress, and the agency had not allowed the public to comment, prompting Public Citizen’s lawsuit.

The U.S. Food and Drug Administration (FDA), a part of HHS, has committed to holding a public meeting and soliciting comments on the program and alternatives to the current system, such as an FDA-regulated patient information program. Currently, the government is not regulating the quality or quantity of information patients receive from pharmacies, and the companies providing it have failed to meet the expectations of Congress.

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.

The law said 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 had refused to take comments on alternative methods of improving the leaflets, in violation of the 1996 law.

“We’re pleased that the FDA is finally agreeing to open this process to the public, but it is frustrating that it has taken a lawsuit to compel it to do so,” said Larry Sasich, Pharm. D., a research analyst with Public Citizen’s Health Research Group. “The private industry first said it would institute a voluntary program in 1982, but consumers still are taking home prescriptions every day without useful and understandable safety information. It is ridiculous that this process has now dragged on for more than 20 years.”

In fact, the FDA found in a 2001 study that the private sector’s most recent information campaign was ineffective. 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 was named as a co-plaintiff in the lawsuit, are not receiving sufficient information about their prescription drugs, as Congress intended. Also, because the FDA had not established a public comment period, Public Citizen was being denied its right to participate in the process.

Click here to view a copy of the settlement. Click here to view a copy of Public Citizen’s original complaint.