Released by FDA: 7/3/00.  Posted by FDA:  7/6/00

Ron Steinhauf 
Vice President, Regulatory Affairs 
Jerome Stevens Pharmaceuticals, Incorporated 
60 DaVinci Drive 
Bohemia, NY 11716

RE:   THYROX (Levothyroxine Sodium Tablets, USP) 
         MACMIS ID# 8964

Dear Mr. Steinhauf:

As part of its routine monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has become aware of promotional materials for THYROX (Levothyroxine Sodium Tablets, USP), a product of Jerome Stevens Pharmaceuticals (Jerome Stevens).  These materials include a journal advertisement (item number JS2401-0004) that appeared in the June, 2000 issue of U.S. Pharmacist, a “Dear Pharmacist” letter (item number JS2400-0004A), and a sales aid (item number JS2400-0004).  We have reviewed these materials and consider them to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations.

Background

None of the currently marketed levothyroxine sodium products is the subject of an approved New Drug Application (NDA).  None of these products have been determined to be equivalent to or inequivalent to any other.  There is no standard product.  Thus, we consider any claims of equivalence, interchangeability, inequivalence, or superiority to be unsupported.

False or Misleading Claims

Jerome Stevens’ promotional materials are misleading because they state that THYROX is “the new standard.”  In support of this claim, the materials state that Jerome Stevens has filed an NDA with the Food and Drug Administration (FDA).  This claim is misleading because it suggests that THYROX is the reference standard for levothyroxine sodium products.  However, neither THYROX nor any other levothyroxine sodium product is currently recognized by FDA as a standard or reference product for levothyroxine sodium products.  The filing of an NDA does not support this claim or implication. 

Similarly, the implied superiority claims inherent in these materials are misleading because THYROX has not been demonstrated to be safer or more effective than any other levothyroxine sodium product.  Claims such as “Unparalleled track record of quality” and "Greater stability ensures more predictable results- easier and less frequent titration — less frequent TSH monitoring” clearly imply THYROX is superior to other levothyroxine sodium products.  These and similar claims would require substantial evidence from head-to-head clinical trials.  Likewise, “One of the only levothyroxine formulations to consistently demonstrate reliable potency, stability, and bloavailability” is an unsupported superiority claim.

Finally, statements such as “all manufacturers who wish to continue marketing levothyroxine must have an approved NDA by August 14, 2000” are now false in light of the Federal Register notice of April 26, 2000 extending the compliance date. (65 FR 24488)

Lack of Fair Balance

The materials lack fair balance because they fail to present any risk information.  Risk information must be presented in a manner reasonably comparable to information about drug efficacy.  Including only the prescribing information or the brief summary does not satisfy this requirement.

Conclusion and Recommendation

Jerome Stevens has promoted THYROX in a manner that creates false or misleading impressions regarding the current status of levothyroxine sodium drug products and with materials that lack fair balance.  Accordingly, Jerome Stevens should immediately cease dissemination of the aforementioned materials and any other promotional materials that contain the same or similar violations.  We request that Jerome Stevens respond to this letter within ten business days of receipt.  Your response should include a statement of your intent to comply with the above, a list of similarly violative materials, and the date on which their dissemination was discontinued.

Direct your response to the undersigned at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD-42, Rm. 17B-20, 5600 Fishers Lane, Rockville, MD 20857.  DDMAC reminds you that only written communications are considered official.

In all future correspondence regarding this particular mailer, please refer to MACMIS ID # 8964.

Sincerely,

Margaret M. Kober, R.Ph. 
Regulatory Review Officer, 
Division of Drug Marketing, 
    Advertising, and Communications