FDA Issues Secret Warning to Shire for Fraudulently Marketing Drug

by Heidi Stevenson

11 March 2010

Shire Pharmaceutical gave patients of their kidney-failure drug, Fosrenol, a brochure titled "How I Stay On Track". It gave false information, did not provide information about risks, made unsubstantiated claims, overstated the efficacy, and said it could be used for things that had never been approved. The FDA's response was to send Shire a warning letter in secret. Nothing was sent to patients. Nothing was sent to doctors. No notice was placed in any publication.

The warning was sent on 5 November 2009, over four months ago, and it's just now receiving some press. Maybe some of the patients will find out, but if they do, it won't be because of the FDA's efforts.

In its letter, the FDA asked Shire to:

• Immediately cease sending the offending brochure to patients.
• Submit a written reply by 20 November 2009 indicating whether they intended to comply.
• Come clean about any other misleading promotional materials.
• Put together and explain a plan to end sending out misleading information.

The FDA's letter further stated, "Because the violations described above are repeated, we request, further, that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials."

At this time, there is no public record of a response from Shire.

Sounds pretty bad—but this is not the first time that Shire has been warned by the FDA about distributing misleading information on Fosrenol. A notebook and medical exam light kit were given to doctors with misrepresentative labeling. The letter sent by the FDA stated, "The pieces misbrand Fosrenol…as they fail to include, among other things, the drug's product indication as well as material contextual information and information addressing the risks associated with Fosrenol."

Shire apparently pulled this marketing gift back, but increasing sales by any means remained their goal. Instead of trying to mislead doctors, they focused on lying to patients. They didn't tell them of precautions that must be taken with "acute peptic ulcer, ulcerative colitis, Crohn’s disease or bowel obstruction". They didn't tell them that pregnant women shouldn't take it. They didn't even tell them about the relatively mild side effects, such as nausea, vomiting, or abdominal pain, and of course, they didn't mention more serious concerns, like headaches, hypotension, bronchitis, or hypercalcemia. All these items are detailed in the FDA's letter.

False claims of how Fosrenol acts were made. They claimed that it can prevent "mineral deposition, bone disease, heart disease, or death"—all false. They implied that it can be used by anyone with hyperphosphatemia (excess phosphorus), though the drug was approved only for end-stage renal disease.

Obviously, Shire has no respect or concern for people who use their products. Nor do they seem to be concerned about the FDA's actions.

Then again, how much concern has the FDA shown for the people they're supposed to be protecting? They appear to have all the concern and sensibility of the gamers in the photo above. Their warning to Shire sounds much like, "Well...uhhh...if ya don't shape up, we're gonna...ummm...we're gonna...well, we're gonna do sumthin! Double-down dare ya!"

The FDA didn't send warnings to doctors. They said nothing to patients taking the drug. They didn't go to the press with the information. They sent a letter to the company with a deadline that wasn't met, and then did nothing. Perhaps they will...somewhere along the line. How many people will have been hurt by then?

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