Warning Letter Summary for Third Quarter 2006

J0185052The rate of Warning Letters coming from DDMAC for violations by pharmaceutical companies continues to come out a slow-paced drip.  The third quarter of 2006 produced only four letters from DDMAC for communications issues. 

DDMAC reviews all types of communications materials for fair balance, claims beyond the approved indication or competitive claims without data, and to ensure that risk information has been included.  Communications includes any sales or promotional items or activities, meaning that the representations of representatives made at medical meeting booths are scrutinized and reported as well as press releases, Web sites, videos, broadcast advertisements, etc. 

Here’s a summary:

  • The first of our Warning Letters centered on a sample request letter that was deemed false or misleading because it failed to communicate any risks associated with the use of the drug and also made claims that were unsubstantiated.  The claim was interesting.  Because the drug was only administered twice a day, as opposed to other treatments that are administered more often, the manufacturer made a statement that this means that patients will comply with treatment more often.  While that is logical to assume, the agency found it only to be an assumption, not backed up by data.  Takeaway lesson – Just because a characteristic of a drug such as convenient dosing might logically mean that it confers an added benefit, that benefit cannot be claimed unless there is data to back it up. 
  • One manufacturer received a Warning Letter regarding two unspecified promotional pieces that were regarding a drug that is indicated for the purpose of prolonging the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease.  The agency said that the company produced two promotional pieces.  One of the reasons for the warning was that, despite a Black Box Warning (BBW), there was no risk information included.  The other reason for the warning was that the language contained in the pieces suggested that the product could be used in a broader patient population than identified in the label, by referring to "Americans diagnosed with atrial fibrillation" as opposed to qualifying it by noting it was for patients without structural heart disease.  The takeaway lesson here – risk information should always be included, particularly if you have a BBW
  • Another manufacturer received a Warning Letter for a journal ad about a product that works as a prophylaxis for organ rejection among transplant patients.  The agency felt that the ad made unsubstantiated superiority claim and minimized risk.  Regarding the risk minimization, despite the fact that the drug comes with warnings on myocardia hypertrophy, the ad stated that there was "favorable cardiovascular profile".  The superiority claim was discerned by language stating that the drug had "superior rejection prevention" – a claim not supported by clinical data. The takeaway lesson here is that any use of words that directly or indirectly imply superiority without clinical data to support it run a risk of warning.
  • A patient brochure by another manufacturer was cited for omitting some facts regarding risk for a drug used in the treatment of lung cancer.  Here, the brochure was cited for not specifically stating the two indications for which the drug was approved.  The language used in the brochure referred to the indication only in general terms such as "treat certain types of cancer."  Also, despite the fact that the label clearly indicates Pregnancy Category D – harm to the fetus, the brochure omitted this warning.  Takeway – list all risk information, especially that to unborn children – and be specific about indication – do not be general in describing what the drug is used for.
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