Released by FDA: 7/13/01.  Posted by FDA:  7/26/01

Suzanne M. Sensabaugh, MS. 
Associate Director, Regulatory Affairs 
Genzyme Corporation 
One Kendall Square 
Cambridge, MA 02139

RE:    NDA20-367 
          Cerezyme (imiglucerase for injection) 
          MACMIS 1D#: 10172

Dear Ms. Sensabaugh:

This Letter concerns Genzyme Corporation’s (Genzyme) dissemination of a direct-to-consumer (DTC) radio broadcast advertisement (ad) for Cerezyme (imiglucerase for injection).   The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed this ad as part of its monitoring and surveillance program and concludes that it is misleading and fails to comply with regulatory requirements.   Therefore, this ad violates the Federal Food, Drug, and Cosmetic Act and applicable regulations. Our specific objections follow.

Misleading Minimization of Material Fact and Risk Information

“Cerezyme (imiglucerase for injection) is generally well-tolerated, however, side effects related to therapy may occur.  The most common side effects include nausea, rash, and hives.  Anaphylactic reactions have been reported in less than l% of the patient population.  Periodic monitoring for antibody formation is recommended.  Patients should notify their health care provider immediately if they experience any side effects with their treatment.”

The ad is misleading because it minimizes a material fact in light of representations made about the drug.   The ad misleadingly minimizes the material fact that this drug is injected into the bloodstream over the course of one to two hours, and does not adequately explain that the patient may experience a variety of local reactions at the site of the injection (e.g., discomfort, itching, burning, swelling, or sterile abscesses).

In addition, the ad lacks fair balance because the content and presentation of the ad misleadingly minimize risks associated with use of Cerezymne.   Specifically, the “generally well tolerated” safety claim is neither stated in the approved product labeling nor supported by substantial evidence.   Furthermore, by presenting that the safety claim at the beginning of the risk discussion, it minimizes the subsequent important information about warnings and side effects related to hypersensitivity reactions. Moreover, some of the listed side effects are not communicated in consumer-friendly language or with the context needed to be understandable to listeners (terms such as “anaphylactic reactions,” “antibody formation,” and “hypersensitivity reactions”). Finally, the speed with which the risk information is spoken is not reasonably comparable to the speed of the presentation of benefits information.

Failure to Fulfill “Adequate Provision” Through Incomplete Presentation

The radio ad does not fulfill the regulatory requirement to either present a “brief summary” of all the risk concepts or to ensure “adequate provision” for disseminating the approved product labeling to a potentially diverse audience of consumers.   The ad provides no source of labeling for consumers who might want to remain anonymous (e.g., a print ad), nor for those who prefer to obtain information rapidly (e.g., through the Internet).  Also lacking is a clear disclosure that healthcare providers, such as doctors, are an additional source of drug product information (rather than “prescribing information” a phrase that is implies that the information is meant only for healthcare providers).

Failure to Disclose Prescription Drug Status

The ad is misleading because it fails to clearly identify that Cerezyme is only available by prescription.

We acknowledge Genzyme’s July 12, 2001, letter to DDMAC stating that the radio ad was aired one time only and was immediately discontinued on June 29, 2001.   Your letter responded to our June 29 2001, telephone conversation during which DDMAC notified Genzyme that, based on the script alone, the ad appeared to be violative and we requested the audiotape for review.   We request that Genzyme review all other promotional materials for Cerezyme to determine if there are other materials with the same or similar claims or presentations.

Please respond to Margaret NI. Koher, R.Ph., by facsimile at (301)594-6771, or in writing at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications HFD-42, Rm. 17-B-20, 5600 Fishers Lane, Rockville, Maryland 20857.   Your written response should be received no later than July 27, 2001, and should include a list of any violative materials, a description of your method of discontinuation, and the discontinuation date for each item.

In all future correspondence on this matter, please refer to MACMIS ID# 10172 as well as the NDA number.  DDMAC reminds you that only written communications are considered official.

Sincerely,

 

Joan Hankin, J.D. 
Consumer Promotion Analyst 
Division of Drug Marketing, 
   Advertising, and Communications