FDA Caters to Physicians

A proposed rule for redesigning prescription drug labeling can help save physician time and reduce adverse drug events.

One of the reasons FDA would like to revamp prescription drug labeling is to make it easier for physicians to access the information most crucial to them. While most of the proposed changes would affect the professional labeling, a few would affect the labeling on the package that the patient receives. FDA proposed the rule in the December 22, 2000 Federal Register (65 FR: 81081­81131).

FDA's proposal came in response to the increasing length and complexity of labeling for new prescription drugs, and after many physicians said the current format can lead to confusion. The agency states that the information most useful to doctors is contraindications, drug interactions, side effects, and dosage and administration. As such, the rule would not apply to drugs approved more than five years before the implementation date, because FDA has found that physicians were more likely to refer to the labeling information on new drugs.

The agency plans to reorganize professional labeling into three main sections: "Highlights of Prescribing Information," "Comprehensive Prescribing Information: Index," and "Comprehensive Prescribing Information." The highlights section would cite those things about a drug that a physician should be most familiar with, and the index would make it easier to find a particular piece of information in the comprehensive section. FDA stresses that reading the highlights section is not a substitute for reading the comprehensive section.

The highlights section would be limited to two columns on one side of a standard piece of typing paper and would not affect any regulations related to the advertising and promotion of prescription drugs. It would begin with the product name, dosage form, and route of administration, along with the Rx symbol to indicate a prescription drug. The inverted triangle symbol would be used for drugs that had been approved for less than three years and if they included a new molecular entity or some other novel element.

Next would come highlighted boxed warnings, not to exceed 20 lines, followed by a list of approved labeling changes that have occurred in the past year. A concise statement of indications, including major limitations of use, would follow. Next would be succinct information about the dosage regimen and then the "How Supplied" section, which specifies dosage forms.

Following would be a summary of contraindications and then the newly formatted "Warnings/Precautions" section. These two facets are being combined because physicians usually don't distinguish between them. Which warnings and precautions should be included in the highlights section should depend on "the seriousness of an adverse reaction and its frequency of occurrence, whether steps can be taken to avoid the adverse reaction and identify and treat it at an early stage, and the likelihood that it could affect patient compliance or continuation of therapy," states FDA.

After a contact number to report serious adverse drug reactions would come a summary of drug interactions and any clinically important difference in response to or use of the drug by specific patient populations. Last would come a referral to patient counseling information, a disclaimer that the highlights section is not all-inclusive, and the date of the latest labeling revision.

An index, which consists of a list with each subheading in the comprehensive section and a number or identifier preceding it, follows the highlights section. The number or identifier also appears next to the subheading in the comprehensive section. The format will be easily adaptable for use as hypertext links when electronic labeling becomes a reality, the agency says.

Significant developments in the proposed comprehensive section include using the International Conference on Harmonization definition of adverse reactions and prohibiting the use of in vitro data in the "clinical pharmacology" section unless a waiver is granted.

The proposed rule calls for moving some information from the label to the package insert to avoid confusion and medication errors. This includes listings of the types of containers that pharmacists should use when filling the drug, inactive-ingredient information, and, in some cases, dosage information. In addition, all headings and subheadings and certain portions of the text must be in bold type, and all text must be in at least eight-point type.

FDA estimates that labeling changes will cost $140.07 million over 10 years. But the savings in physician time and the prevention of some adverse drug events should produce a savings of $447.67 million, the agency says.

Comments on the proposed rule must be submitted by March 22, 2001, to the Dockets Management Branch (HFA-305), FDA, 5630 Fishers Ln., Rm. 1061, Rockville, MD 20857.

For further information, contact Nancy M. Ostrove at 301/827-2828, Ostrove@cder.fda.gov.

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