WASHINGTON, D.C. -- April 18, 2003 -- The United States Department of Health and Human Resources (HHS) has agreed to a settlement under which it must allow formal public comment about providing patients with better information concerning their prescription drugs. The Department had been relying on a faulty, voluntary, private-sector program that did not meet the requirements of a 1996 federal law, according to Public Citizen, a non-profit consumer advocacy group that filed the lawsuit against the government.
The U.S. Food and Drug Administration (FDA), a part of HHS, must hold a public meeting and solicit comments on the private prescription information program as well as on alternatives such as an FDA-regulated patient information program. Currently, the government is not regulating the quality or quantity of information patients receive from pharmacies.
In 1995, the FDA proposed a rule requiring the distribution of scientifically accurate and useful written information with all new and refill prescriptions, including details about adverse drug effects. The FDA set these goals: by 2000, 75 percent of patients would be receiving patient information leaflets, and by 2006, 95 percent would be receiving them. A federal law, P.L. 104-180, adopted that timetable and required the private sector to design and implement the program. If it did not do so, the FDA was required to take public comments on alternative methods for providing information leaflets to prescription drug consumers.
The FDA has acknowledged that the private sector failed to meet the 2001 goals. While 89 percent of patients were receiving information leaflets, the leaflets contained only half the information considered necessary for a patient to take a drug safely. None of the leaflets met the quality criteria of the proposed rule.
"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, a research analyst with Public Citizen's Health Research Group (Press Release, April 7, 2003). "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."
A public meeting about consumer prescription drug information will be set for July, 2003. The comment period will be announced in a forthcoming Federal Register. Public Citizen has provided the full text of the settlement agreement on its web site. (If you do not already have Adobe Acrobat Reader installed on your computer, you may download a free copy in order to access the settlement agreement).
Brayton Purcell believes that consumers should receive appropriate prescription drug information. We are also concerned about the effectiveness and safety of prescription drugs. If you or a family member has been injured through the use of an unsafe prescription drug, please feel free to contact us to learn about your legal options.