Toll-Free Number For Adverse Event Reporting Due On Labels By Mid-2009
Executive Summary
Industry will have an extra six months - until July 1, 2009 - to comply with a requirement that drugs be dispensed with information on a toll-free number for reporting adverse events, according to a final rule on the topic issued by FDA Oct. 28
|
Industry will have an extra six months - until July 1, 2009 - to comply with a requirement that drugs be dispensed with information on a toll-free number for reporting adverse events, according to a final rule on the topic issued by FDA Oct. 28. The regulation originally was proposed in 2004 and issued as an interim rule last January to meet a deadline set by the FDA Amendments Act (1 (Also see "Adverse Event Hotline On Rx Bottles Gets Final Rule; No Enforcement Till 2009" - Pink Sheet, 7 Jan, 2008.), p. 18). The 2 final rule adopts the interim measure without change. However, when issuing that rule, FDA said it would not begin enforcement until Jan. 1, 2009. Now, because of the short interval between the final rule's publication and that date, FDA is delaying enforcement another six months. At the time the interim rule was issued, FDA was still studying alternate phrasings to see which statement conveyed the information most effectively. That 3 study is now complete, and the agency concluded there were minimal differences in comprehension between the different possibilities - with the arguable exception of one that started with a question ("Side Effects?") reminiscent of a milk awareness campaign - so the final rule requires that prescriptions be dispensed with the original statement: "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088." Pharmacies must distribute the statement with all new prescriptions and refills, using either a MedGuide, a sticker attached to the drug container/package, a preprinted pharmacy prescription vial cap, a separate sheet of paper or as part of consumer medication information. FDA finalized its proposed side effects statement based on a comprehension study and factors such as length and readability. The requirement for mentioning the toll-free number will cost drug makers $36 million to $49.6 million in capital outlays and $17.1 million in annual expenditures, according to agency figures. On an annualized basis, drug firms could spend as little as $4.5 million or as much as $24.2 million, FDA estimates. There are no expected capital costs for either retail or non-retail pharmacies, but the drug dispensers could incur annual costs of $12.4 million to $27.3 million, FDA says. Annual costs to the agency are predicted to be $1.9 million. These expenditures do not classify the regulation as economically significant, FDA concludes. - Cathy Dombrowski ([email protected]) |