CBER and DDMAC promo untitled letters.

The following untitled letters were issued by either the Center for Biologics Evaluation and Research's (CBER) Advertising and Promotional Labeling Branch (APBL), or Office of Medical Policy Division of Drug Marketing, Advertising and Communications (DDMAC). Copies of these letters are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval.

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Merck, West Point, PA, Dec. 19 (CBER). Through routine monitoring and surveillance, the Advertising and Pro-motional Labeling Branch (APLB) of CBER identified a Dose Spacing Slide Rule (20302533-01-CMV) for Merck's Comvax [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine], that was misleading. Specifically, APLB determined the Slide Rule contained false or misleading representation with respect to GlaxoSmithKline's Pediarix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined], and its compliance with certain immunization recommendations. These recommendations are issued by Centers for Disease Control and Prevention (CDC) and approved by the American Academy of Pediatrics (AAP) and Advisory Committee on Immunization Practices (ACIP). FDA said the Slide Rule, which consists of two pull-out tables that compare the dosing schedules of Comvax and Pediarix, represents that, in each of the eight dosing scenarios, Comvax is in compliance with AAP/ACIP recommendations for minimum hepatitis B dose spacing and Pediarix is not. CBER found this to be misleading because Pediarix will not always be non-compliant with AAP/ACIP recommendations when doses are delayed, and noted the disclaimer, appearing in small print in one part of the Slide Rule and conveying that Pediarix fails to comply with AAP/ACIP recommendations if the third dose is given "on time at 6 months of age," is insufficiently prominent to correct the false or misleading representation that Pediarix does not comply with the recommendations in the scenarios described in the Slide Rule. Lab

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Organon, West Orange, NJ, Dec. 12 (DDMAC). DDMAC identified the company's promotional detail aid for Follistim (follitropin beta for injection) as misleading because it minimized the risks associated with Follistim and made unsubstantiated superiority claims for the drug. Although risk information includes that the substance is capable of causing Ovarian Hyperstimulation Syndrome (OHSS), the promotional aid minimizes the possibility of the serious medical disorder by confining it to a single-spaced, paragraph without additional emphasis, on the last page of a six-page document. In contrast, effectiveness claims are presented as large, colorful, bolded headers, the agency said. The detail aid also contains superiority claims by indicating that the product produces "larger numbers of embryos for cryopreservation;" and that the product requires smaller doses, fewer treatment days, and less monitoring than other similar urofollitropin for injection treatment options. The agency emphasized that it is not aware of any substantial evidence or substantial clinical experience demonstrating that Follistim provides a treatment duration that is superior. F-B

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Xcel Pharmaceuticals, San Diego, Dec. 19 (DDMAC). The agency took issue with Xcel's detail aid for Migranal (dihydroergotamine mesylate) Nasal Spray and an accompanying insert for D.H.E. 45 (dihydroergotamine mesy-late) Injection), because they contained misleading information. Specifically, the detail aid states that Migranal Nasal Spray works in a similar way to triptans and has a comparable safety profile, but the letter points out that comparable safety of Migranal to triptans has not been demonstrated by substantial evidence or substantial clinical experience. The accompanying insert for D.H.E. states that it was "developed as a safer alternative to ergo-tamine," but the agency noted that the superior safety of dihydroergotamine to ergotamine has not been demonstrated by substantial evidence or substantial clinical experience. The company was also cited for failing to pre-sent certain contraindications from their respective PIs. Specifically, the detail aid and the insert failed to include the contraindications that patients with uncontrolled hypertension, patients who have used 5-HT1 agonists, ergotamine-containing or ergot-type medications, or methysergide within the last 24 hours, or patients with hemiplegic or basilar migraine should not use Migranal or D.H.E. 45. Furthermore, the detail aid and the insert were misleading because they minimize the risk information for Migranal and D.H.E. 45. All of the risk information for Migranal and D.H.E. 45 was relegated to the second page of the detail aid and the second page of the insert and is presented in a single-spaced paragraph format without additional emphasis. The company was also hit with un-substantiated efficacy claims, such as claiming the product provided "complete headache relief," and with broadening of indication by claiming the product D.H.E. may be used intravenously for "management of refractory, intractable migraine," although D.H.E. 45 is not indicated for the treatment of status migrainosis or intractable migraine, and FDA is not aware of substantial evidence demonstrating as much. F-B