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February
25, 2003 Prescription Info is Inadequate, Consumer Group Claims
The consumer group Public Citizen
has filed a suit against HHS, hoping to prod them into improving the safety
information found in prescription drug packaging. The suit claims that
the FDA has been too slow to seek public input on the information. A 1996 law requires private companies to develop prescription information leaflets that contain accurate and adequate information on side effects and the best ways to use the drug. The law required that at least 75 percent of all prescriptions contain such information by 2000, and ordered HHS to “seek public comment on other initiatives that may be carried out to meet such goals” if the private sector failed to meet the law’s requirements. In June 2002, the FDA reported that approximately 89 percent of patients received written information with their prescriptions, but that on average the leaflets had only half the information necessary for a patient to take the drug safely. The FDA said that it would continue to work with the private sector in improving the information, so that 95 percent of patients would receive adequate information with their prescriptions by 2006. Public Citizen says that the failure to meet the 2000 requirements is enough to trigger the law’s requirement for public input. To read the Public Citizen brief, go to http://www.publiccitizen.org/documents/FDAComplaint.pdf. |
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