Food, Drug and Devices — October 2000 Compilation

Decisions   Foods   Human Drugs and Biologics   Animal Drugs    Cosmetics   Medical Devices

Recent Court Decisions

D.C. Circuit upholds FTC advertising restriction for OTC back pain product.   Novartis Corporation, the manufacturer of Doan’s Pills, an over-the-counter back pain remedy, was ordered to cease advertising superior efficacy and to publish a correction in future advertising and packaging. According to the Federal Trade Commission (FTC), the advertising truthfully claimed that the product was effective for back pain relief and contained an active ingredient (magnesium salicylate) not found in other OTC products. However, the Commission found the claims implied unsupported product superiority. Because the manufacturer’s advertisements deceptively created or reinforced consumer belief in product superiority, the manufacturer was ordered by the FTC to include a disclaimer of superiority in all advertising and packaging for one year and until a sum equal to the average spent annually on the deceptive advertising campaign is expended. An exception to the advertising disclaimer was allowed for any television or radio advertisement that is fifteen seconds or less (Novartis Corporation v. FTC, D.C. Cir., ¶38,635).

Prozac® patent term extension denied. Eli Lilly’s attempt to prevent generic equivalents for its antidepressant, Prozac (fluoxetine hydrochloride) from entering the market until 2003 was thwarted by the U.S. Court of Appeals for the Federal Circuit. According to the court, Lilly’s claim to fuoxetine hydrochloride for use in preventing serotonin uptake in an animal’s brain was invalid for obviousness-type double patenting because the original patent claimed an entire class of disclosed compounds for treating human depression, and genus claims are not patentable over an earlier species claim. As the court further reasoned, the original patent excluded competing uses of thousands of compounds within the original class, which included fluoxetine hydrochloride during the original exclusivity term, which expired in 1994; the substance could not now be isolated from the class to shield the company from competing ANDAs based on the substance. Otherwise such an extension would be the kind of result the obviousness-type double patenting doctrine is designed to prevent. The ruling opens the door for generic manufacturers such as Barr Laboratories, who filed an ANDA in December 1995, to market fluoxetine hydrochloride, to enter the market. Lilly indicated that it will appeal the decision to the U.S. Supreme Court. If the double patenting invalidation is upheld, Barr’s generic product could appear on the market as early as August 2001. (Eli Lilly and Co. v. Barr Laboratories, Inc., Fed. Cir., ¶38,634)

Decisions   Foods    Human Drugs and Biologics   Animal Drugs    Cosmetics    Medical Devices

Foods

FDA and FSIS to jointly review food and color additive petitions. The review procedures for food and color additive petitions were recently streamlined. The changes also cover radiation petitions for meat and poultry products. Previously, the FDA and FSIS conducted separate, sequential reviews of food and color additive and GRAS petitions, resulting in costly, duplicative filing for industry. Under the new rule, petitioners need only file one petition with the FDA for a single, government-wide approval or GRAS status determination. The FSIS will receive and review a copy of the petition simultaneously with the FDA. FSIS will report to the FDA on the additive’s efficacy, suitability, and any necessary conditions that should be placed on usage prior to the additive’s approval or a GRAS affirmation. The FDA will review and incorporate appropriate FSIS conditions when issuing or amending regulations. The rule also incorporates a recent FDA/FSIS memorandum of understanding (¶43,144) to harmonize review processes in order to ease the regulatory burden on industry, reduce government administrative costs, and increase the speed in which safe, lawful additives are introduced into the market. The rule is effective August 25, 2000, and provides specific procedures for filing the petitions. The information collection provisions are pending OMB approval and written comments may be submitted on them to the Dockets Management Branch through October 24, 2000 (FDA Order ¶40,088).

Decisions   Foods    Human Drugs and Biologics   Animal Drugs    Cosmetics    Medical Devices

Human Drugs and Biologics

FDA amends OTC antifungal drug monograph. The OTC final monograph for topical antifungal drug products was amended to require a minor labeling change inserting the word "most" between the introductory indications phrase and the condition for which the products will be used. The qualifier will facilitate accurate expectations to consumers. The labeling compliance date is May 16, 2002. The compliance date for businesses with less than $25,000 in annual sales is May 16, 2003. The compliance dates were harmonized with the new standardized format and standardized content requirements for OTC drug product labeling (FDA Order ¶40,090).

Uniform labeling for oral contraceptive products—draft guidance published for comment (¶41,158A)

Blood derivative standards revision. For consistency with current industry practices and to remove outdated requirements, the FDA recently amended the biologics regulations applicable to the human blood derivatives albumin, plasma protein fraction, and immune globulin. The amendments were originally made by direct final rule, but significant adverse comments resulted in the agency’s confirmation of only unopposed amendments. The agency particularly disagreed with adverse comments on heat treatment, stabilizer use, and sterilization. The amendments are effective September 27, 2000 (FDA Order ¶40,089).

Decisions   Foods    Human Drugs and Biologics   Animal Drugs    Cosmetics    Medical Devices

Animal Drugs

FDA reclassifies sheep as minor species. The FDA classified sheep as a minor species for determining human food safety of edible products. Sheep were previously classified as a minor species for target animal safety and effectiveness studies, but as a major species for human food safety purposes. The change is based on new data regarding drug metabolism similarities between sheep and cattle, rather than consumption levels. The agency believes that drug metabolism is more significant than consumption data for determining the major/minor status of species because metabolism demonstrates the reliability of data extrapolated from a major species. The reclassification of sheep as a minor species will allow sponsors of supplemental new animal drug applications to extrapolate human food safety data from a major species such as cattle to sheep. The rule is effective September 5, 2000 (FDA Order ¶40,086).

Veterinary drug impurities guidance (¶41,157A)

Decisions   Foods    Human Drugs and Biologics   Animal Drugs    Cosmetics    Medical Devices

Cosmetics

OTC sunscreen monograph. The FDA extended the final OTC sunscreen monograph compliance date until December 31, 2002 to include standards for ultraviolet A (UVA) and ultraviolet B (UVB) radiation ( ¶40,081). The agency published the monograph for sunscreen products under the Food and Drug Administration Modernization Act of 1997 (FDAMA) on May 21, 1999. However, the monograph did not address active ingredients, labeling, and testing issues for UVA coverage products. The FDA changed the effective date for the sunscreen monograph to accommodate pending standards for UVA formulation ingredients, labeling, and testing. When finalized, the comprehensive monograph will address testing and labeling issues of sun protection factor (SPF) values above SPF 30. The agency will also consider including UVA and UVB indications.

"Warning—This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn." (21 CFR §740.19, ¶78,344).

To review the full sunscreen monograph, or other OTC Monographs, consult CCH Food, Drug & Cosmetic Law Reporter

Decisions   Foods    Human Drugs and Biologics   Animal Drugs    Cosmetics    Medical Devices

Comment period opens for postmarket surveillance requirements proposal. The FDA proposed the implementation of postmarket surveillance (PS) regulations for serious health risk devices. The FDCA, as amended by FDAMA, authorizes the FDA to require a manufacturer to conduct PS of a Class II or III device if its failure would be reasonably likely to have serious health consequences, if it is intended to be implanted in the human body for more than one year, or if it is intended to be life-sustaining or supporting and is used outside a device user facility. The proposed regulations are intended to ensure the collection of data useful in addressing safety, effectiveness, and public health issues related to the devices for which the agency has issued PS orders. The regulations govern FDA notification of the PS requirement, PS plan content, the FDA review process and action on PS submissions, manufacturer responsibilities with regard to timely submissions, waivers and exemptions of PS requirements, and manufacturer maintenance of reports and records. Comments on the proposal may be submitted to the FDA Dockets Management Branch through November 27, 2000 (FDA Proposal ¶11,815).

FDA reclassifies extracorporeal shock wave lithotripter. Extracorporeal shock wave lithotripters, when used to fragment kidney and ureteral stones, were reclassified from Class III to Class II by the FDA. The Gastroenterology and Urology Devices Advisory Panel recommended the reclassification because it believes that risks of bleeding, renal injury, cardiac arrhythmia, urinary obstruction, infection, injury to adjacent organs, and other reported complications that may be associated with the devices can be controlled through special controls of consensus standards (regarding shock wave characterization measurements and general mechanical and electrical safety), clinical performance testing, labeling restrictions, and physician training restrictions. A guidance document describing the information to be included in a premarket notification submission to support findings of substantial equivalency for the devices, including potential special controls was also issued by the FDA. The rule is effective September 8, 2000 (FDA Order ¶16,682)