Food and drug law in biotechnology

Food and Drug Law in Biotechnology

For prescription drugs, what is advertising and what is labeling under the FD&C Act? What are FDA's requirements for prescription drug advertising? Please discuss both print and broadcast advertising.

Congress passed the Federal Food, Drug and Cosmetic Act of 1938 (FD&C) in part as a reaction to the dangerous claims manufacturers were attaching to the medicines and potions of the day, and to safeguard the public from dangerous products. False labeling of drugs and cosmetics was prohibited, and labeling materials were identified as "written, printed or graphic matter accompanying the product" (21 CFR Part 201).

The FD & C. Act and subsequent Code of Federal Regulations restrictions on labels include misbranding of consumer products. The barred actions are use of a label that lacks accurate and full descriptions of the ingredients, or a label not properly displayed on the actual product, or a label that fails to meets the Poison Prevention Packaging Act of 1970, by omitting toxic information. The FD&C Act also does not allow FDA "approval" of cosmetics before they are manufactured and marketed, and any labeling claim of such FDA approval for any cosmetic is also a labeling offense. (Dunn 1938)

Years later, The Drug Amendments of 1962 (Kefauver-Harris) established pre-marketing testing requirements, mandated "Good Manufacturing Practices," expanded the FDA's role, and regulated advertising -- materials and claims issued apart from those regulated as labeling. Under these amendments and the CFR sections written to enforce them, the FDA reviews and regulates prescription drug advertising and promotion (21 CFR Part 202). By contrast advertising for over-the-counter drugs is under the jurisdiction of the Federal Trade Commission. (Hutt and Merrill 1991)

These drug advertising rules have two central tenets: under most circumstances, a company may only advertise a drug "for the specific indication or medical use for which it was approved." The second requirement is that ads and promotion must contain a "fair balance" of warnings regarding the risks of a using a particular drug, and the so called beneficial uses touted by the vendor.

When manufacturers of prescription drugs (product sponsors) target the general population of consumers and patients, it is referred to as "direct-to-consumer" promotion or DTC. The manner these audiences are reached may include television and radio advertisements, print, telephone, direct mail, video or brochures. Section 502(n) of the FD&C Act specifies that prescription drug advertisements must contain "a true statement of . . . information in brief summary relating to side effects, contraindications, and effectiveness" of the advertised product.

CFR part 202 makes a distinction between print ads and TV/radio commercials (broadcasts). For print advertisements, it is set out that that "every risk addressed in the product's approved labeling" has to be included in the advertising copy. By contrast all broadcast advertisements need only to disclose the "most significant risks" those actually appear in the labeling, as long as they also include a summary of all necessary information related to "side effects and contraindications." Obviously this advantage has encouraged the flood of TV drug ads!

2. Discuss the GRAS/GRAE exception and how it formed the basis for FDA's regulation of OTC drugs.

There have always been a category of drugs sold in the United States with the necessary FDA approval. Generally this group of products are not being marketed in under the over-the-counter (OTC) drug review either The "generally recognized as safe, and generally recognized as effective" (GRAS/GRAE) exception originally referred to only those old drugs that did not require prior approval from the U.S. Food and Drug Administration, because they were in wide use before the 1938 Act (grandfathered in, as it were). (Dunn 1938)

The problem was that Act contained a definition for a "new drug" (one in need of prior approval to market), as any drug "the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." FDCA § 201(p) (1). The manufacturers set out to establish then, that anything GRAS/GRAE therefore was not a new drug, and needed no FDA blessing.

Many medicines are ancient, and the active ingredients of many drugs on were first introduced before 1938. To make matters worse, between 1938 and 1962, the FDA considered drugs that were identical, related, or similar (IRS) to any approved drug to be covered by that approval, permitting IRS drugs to be marketed without independent approval.

Naturally, some companies brought drugs onto the market between 1938 and 1962 based on their own conclusion that the products were generally recognized as safe and effective (GRAS/GRAE), or based on an opinion letter from FDA that they were not new drugs. Conversely, a medicine would not be considered a new drug if it is generally recognized as safe and effective (GRAS/GRAE) and has been used to a material extent and for a material time. See 21 U.S.C. 321(p) (1) and (2).

The impact on the over-the-counter market (drugs that are available to consumers without a prescription) was as expected. As with prescription drugs, the FDA oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh their risks. The basis for FDA oversight is similar to the GRAS/GRAE standard because OTC drugs generally have these characteristics:

their benefits outweigh their risks the potential for misuse and abuse is low consumer can use them for self-diagnosed conditions they can be adequately labeled health practitioners are not needed for the safe and effective use of the product (Hutt and Merrill 1991)