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Product Labeling & Pharmacoeconomic Information
  by Louis A. Morris, Pharmaceutical Executive, May 2004

sking the Food and Drug Administration (FDA) to describe the role of product labeling at the agency is like asking an auto mechanic to describe the role of his wrench. The approved label on a pharmaceutical product is the basic tool that the FDA uses to characterize the
effects of that product and to determine whether the advertising for the product is consistent with the legal requirements specified by the US Food, Drug and Cosmetic (FD&C) Act.

Labeling and advertising under the act
Under the FD&C act a drug may be approved only for the conditions specified in its labeling. Although physicians are free to prescribe products for any conditions they deem appropriate, drug companies are legally limited in their sales and marketing to using only those promotional claims that are consistent with a product's approved labeling or that have been otherwise substantiated.

Many written materials distributed directly by drug companies are considered "labeling" under the FD&C Act. Although people often think of labeling as the package insert or the material printed in the Physicians Desk Reference, labeling is legally considered to be any written, printed or graphic matter that "accompanies" the product. The material does not have to physically accompany the product to be considered labeling, but it must be linked to the product, for example, by providing a description of the product's uses. These rules apply to materials distributed by or on behalf of drug manufacturers, packers or distributors of the product. Many product brochures, journal reprints, and other written, printed and graphic materials that discuss regulated products and are distributed by sales representatives are considered to be labeling.

The FD&C Act prohibits the distribution of labeling that is "false or misleading in any particular." As a practical matter the FDA does not insist that product claims be limited to the information contained in the product's approved label, but the FDA does insist that the information be "consistent with, and not contrary to," the approved labeling. Claims contrary to or inconsistent with the label may "misbrand" the product (an illegal act). Claims not contained within the approved product labeling must be supported by substantiating evidence to ensure that an adequate scientific basis for the claim exists.

In reviewing evidence to support advertising and labeling assertions, the FDA, through its Division of Drug Marketing, Advertising, and Communications (DDMAC), is particularly sensitive to 2 types of product claims: new-use claims and comparative claims. New-use claims occur when promotional information states or suggests that a drug is effective for a new indication, claims that may obviously influence prescribing decisions. If physicians prescribe a drug whose benefits have not been adequately demonstrated and whose risks are not fully known, an increased public health risk may result. New-use claims must be supported by adequate and well-controlled trials that ensure safety and efficacy. Claims providing direct comparative data about a product's performance relative to other products are also likely to influence prescribing decisions. Scientific support for comparative claims should be substantial. However, adequate comparative research may be difficult to perform, especially in trials intended to assess product equivalence. For example, underpowered studies or poorly measured outcomes may result in a failure to find differential effects that actually exist. Direct comparative claims require substantiation based on adequate and well-controlled trials that permit fair evaluations among competing products.

In addition to reviewing the substantiation for product claims, the FDA reviews promotional material to confirm that the material provides readers with sufficient disclosures about a specific product's risks or limitations. The failure to reveal material facts can mislead an audience. Disclosures may be made in the form of modifications to specific claims, so that the audience can fully understand the context for and the limits to promoted effects (such as the specific population studied, the length of a measured effect, or the nature of a response scale). In addition, advertising and labeling materials must be "fairly balanced." This provision requires that manufacturers disclose important risk information along with the promoted benefits of a product.

As a matter of general policy the FDA has historically encouraged the free flow of scientific information from drug companies to prescribers. The FDA does not restrict drug companies from discussing their drugs in nonpromotional contexts such as stockholder materials or the scientific literature. Drug companies are free to publish findings from their studies and editorial opinions from their employees in the medical literature, even if the information is contrary to the product labeling. The FDA does not object to the industry's providing a response that contains off-label information to an unsolicited request from a consumer or health care professional, as long as the request is independently generated (ie, prompted by the drug company). A recent court decision, however, suggests that FDA policies limiting the support of the pharmaceutical industry for scientific and educational materials may reach too far and infringe on commercial free speech. FDA position papers on industry support of continuing medical education and on the distribution of textbooks and reprints of pivotal studies have been held to be unconstitutional.

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