Regulatory Focus: Pinning Down New Labeling Rules


By David Vaczek, Senior Editor

As it has done with antidepression drugs, FDA in its new labeling rules for NSAIDs has stipulated a class label. In other words, the labeling is identical for all the drugs in the class. The labeling includes the package insert (PI) for professionals and the Patient Medication Guide (MedGuide) that must be distributed to patients with each prescription. Also, FDA says that MedGuides would replace any patient package inserts (PPIs) currently provided with the drugs.

PPI distribution is required only for estrogen-containing products and asthma inhalers. However, many drug manufacturers distribute the patient inserts voluntarily with some drugs. There is no set format or content for PPIs, as there is with MedGuides, but their content must be approved by FDA as part of drug labeling.

Apart from these two drug classes, MedGuides have been required for about 30 drugs. The content has been individual to a particular drug, and FDA has typically requested the use of a MedGuide during the drug approval process, says Thomas McGinnis, RPh, PharmD, director of pharmacy affairs, FDA.

“MedGuides [for the antidepression and NSAID drugs] are generic. Every drug in the class can use the same information,” McGinnis says.

For instance, the MedGuide for the Cox-2 inhibitor selective NSAID Celebrex will be the same as the guides for the other NSAIDs. The Celebrex PI, however, will contain information specific to that drug, including clinical trial data demonstrating an increased risk of adverse cardiovascular events for celecoxib.

MedGuides are about two pages long, with type no smaller than 10-point size. They all follow a standard format (21 CFR Part 208, Sec. 208.20). This ensures that consumers find the information in the same place for every drug. The format “is consistent from product to product, like the OTC Drug Facts label, or food labeling,” McGinnis says.

Draft changes to the NSAID PI include a boxed warning and about six pages of additional copy on risks and precautions.

OTC NSAIDs will feature more risk information, stronger reminders on dosage and treatment duration, and instructions on which patients should seek physicians’ advice before using the drugs.

In announcing the NSAID labeling in April, FDA said the changes should be implemented within three months from a manufacturer’s submission of the supplement labeling, or at the first printing following the label revision submission.

FDA is encouraging unit-of-use forms with both these classes. “We have said that the ultimate goal is to have the MedGuides attached to unit-of-use packaging for the prescription antidepressants and NSAIDs,” says Crystal Rice, FDA spokesperson.

FDA also has published a draft guidance document on Consumer Medication Information (CMI), titled “Useful Written Consumer Medication Information” (May 26, 2005, Docket-0169). Such CMI is printed material intended to guide patients in the safe use of prescription drugs. Surveys by FDA and others have shown that these guides are widely distributed by pharmacies, but that they are often deficient in quality. Neither FDA nor drug manufacturers review the guides’ content.

With the guidance document, FDA is advising developers of CMI on how to evaluate the patient guides and develop material that meets usefulness criteria defined by a 1996 task force. A task force comprised of stakeholders across the healthcare spectrum defined standards and goals for patient information in “Action Plan for the Provision of Useful Prescription Information.”

The task force and action plan were mandated by federal law (Public Law 104-180), which set a target that 95% of patients should receive useful oral and written information with their prescriptions by 2006. The law prohibits FDA from regulating CMI content and format so long as the private sector meets the target goals.

FDA is a taking a more active role on CMI as the federally mandated deadline looms. “FDA stated its belief that the voluntary approach to improving the distribution of useful CMI could still work to meet the legislatively mandated 2006 level if efforts to improve begin immediately,” the agency reported.


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