FDA Planning Label Update for Dozens of Drugs

FDA Planning Label Update for Dozens of Drugs

May 22nd, 2014 // 1:13 pm @

Aiming to jump-start a largely idle safety initiative, the U.S. Food and Drug Administration on Tuesday detailed plans for a government contractor to help pharmaceutical companies update warning labels for hundreds of older products.
The move stems from a 2006 regulation known as the physician labeling rule, which required prescription drugs approved after June 30, 2001, to adopt new formatting for disclosing risks, dosage and various scientific data.

That mandate has only resulted in label updates for 15 percent of the drugs on the market, and so the FDA is offering an incentive in hopes of winning voluntary compliance with the rule. Specifically, the agency is hiring an outside company to help do the heavy lifting for drugmakers by preparing a draft version of new labeling.

The FDA floated its labeling proposal in February 2013, and it reported Tuesday that feedback was largely supportive from commenters who said that a contractor would reduce the chances of inconsistency and confusion that could emerge if drugmakers were expected to overhaul labels entirely on their own.

“Public comments … supported the initiative, including the use of a government contractor to ease the resource burden on application holders and to facilitate conversion to the [new] format,” regulators wrote.

Under the FDA’s plan, 375 companies will be contacted over the course of five years regarding 750 products. The agency estimates that there will also be ripple effects for nearly 1,900 generic drugs, which are required to update their labels in accordance with changes to the labels for brand-name products.

The fact that 85 percent of drugs don’t have updated labels suggests that a sizable number of products with at least moderate risks are using old formats. In its announcement, the FDA said it would select the 750 medications “based on criteria that would maximize the benefit to the public health, including volume of prescriptions, clinical relevance and risk-based considerations.”

While costs for companies will be reduced by the use of a contractor, there could be noteworthy expenses in the handful of cases where label revisions are so extensive that new packaging is needed to accommodate printed inserts. The FDA projects that about two dozen drugs would be affected in that manner, and that they would incur costs of about $245,000 apiece.

The government contractor, which will receive $26 million for its work, is Reed Technology and Information Services Inc., a unit of Law360 parent company and LexisNexis owner Reed Elsevier Inc.


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