Released by FDA: 7/19/01.  Posted by FDA:  7/30/01

Ellen R. Westrick
Executive Director, Office of Medical/Legal 
Merck & Co., Inc.
UG3BC-10 
P.O. Box 1000 
North Wales, PA 19454-1099

RE:   NDA# 20-560
         Fosamax (alendronate sodium tablets) 
         MACMIS ID # 9727

Dear Ms. Westrick:

As part of its routine monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has become aware of the Fosamax web site www.FOSAMAX.com (6-20-01) disseminated by Merck & Co., Inc. (Merck) which promotes, this drug product in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations.   Specifically, we object because the web site overstates the benefits of Fosamax while minimizing the risks associated with the drug.

Overstatement of Benefit

In the patient information section of the Fosamax web site, each web page has the same side bar on the left side of the page.  The side bar consists of links to other web pages within the Fosamax web site.  One link is titled "Preserving Your Independent Lifestyle."  Use of this phrase in the context of product-specific promotional materials misleadingly implies an outcome of Fosamax treatment that has not been demonstrated by substantial evidence.  Therefore, this claim is misleading because it overstates the potential benefit of Fosamax.  Previous correspondence, dated October 4, 2000, addressed this concept in our response to your request for comment.

The information provided regarding the use of Fosamax in conjunction with Estrogen/Hormone Replacement Therapy (ERT/HRT) which appears in the patient information portion of the web site is misleading because it does not include facts material in light of representations made.  For example, you provide information that "In clinical studies, the combination of FOSAMAX and ERTAHRT increased bone density more than either FOSAMAX or HRT alone."  This presentation is misleading without the additional contextual information from the approved product labeling (PI) that no significant effect was seen for total body bone mineral density (BMD) or that the long-term effects of combined Fosamax and HRT on fracture occurrence and fracture healing have not been studied.

Inadequate Communication of Risk Information

The "Product Highlights" section of the healthcare professional portion of the web site is further divided into headings entitled "Efficacy," "Proven Tolerability," and "Indications." Presenting risk information under the heading "Proven Tolerability" minimizes the serious adverse effects associated with Fosamax therapy.  According to the PI, these effects include cases of severe esophageal adverse reactions requiring hospitalization.  Previous correspondence, dated December 20, 2000, and January 18, 2001, addressed this concept in our response to your request for comment.

The warning that patients should discontinue Fosamax and seek medical attention if they develop signs or symptoms signaling a possible esophageal reaction is incomplete because it does not include new or worsening heartburn.  Therefore, the presentation is misleading because it is inconsistent with the PI in regard to this important warning. Previous correspondence, dated December 20, 2000, addressed this concept in our response to your request for comment.

The reference to inclusion of "Up to 54% of patients with a history of GI disorders at baseline" in the postmenopausal osteoporosis treatment studies is misleading.  It does not convey the material information that patients who had a history of major upper GI tract disease were excluded from the studies.  Previous correspondence, dated October 23, 2000, addressed this concept in our response to your request for comment.

DDMAC requests that Merck immediately discontinue the violative portions of the web site and all other promotional materials that contain the same or similar violative claims or representations.  DDMAC requests that Merck submit a written response to this letter no later than July 5, 2001, including your plan to comply with DDMAC's request. Your written response should include a list of all materials that you have discontinued and the date that they were discontinued.

If you have any questions or comments, please contact me by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD-42, 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 matter, please refer to MACMIS ID #9727 in addition to the NDA number.

Sincerely,

 

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