Yesterday there was a quantitative look at the Warning Letters and Notice of Violation (NOV) etters that showed that after years of decline in enforcement, there is no uptick in DDMAC's issuance of these regulatory letters. Today, the qualitative aspects of the letters. What did they say – what were the violations?
First of all, we are looking at a total of 11 letters, 4 (NOV) letters and 7 Warning Letters. Let's first examine the NOV letters. Tomorrow, we'll look at the Warning Letters.
- August – A journal advertisement was found to have several violations, including a broadening of indication, unsubstantiated efficacy claim. In this case, the product was touted as saying that the condition stops with use of the product. However, the indication was actually for some specific types of the condition and for people with particular characteristics. By stating outright that use of the product stops the condition, DDMAC stated that it implied all patients with all types of the condition could use the product, which is not the case. The ad also did not include the Contraindication or any of the Warnings and Precautions information. Lesson – Avoid blanket statements. Lesson – All risk information, don't pick and choose.
- September – Both a FAQ and a Web site were found to omit risk information when a timeline was used to show the history of the condition and the arrival and approval of the product. Where the product approval was noted on the timeline, there were indication and efficacy claims, but risk information was contained in a small space near the timeline, which omitted some of the imporant risks associated with the product. Referring the reader to the Web site for "full prescribing" information was deemed inadequate.
- October – A voucher tent card was found to present efficacy claims without communicating the indication or risk information. The tent card on one side presents questions about the symptom, but does not directly state the indication of the drug nor is there any risk information. The indication and the risk information are on the back side of the tent card, and the front side did refer the reader to the back side. Lesson – putting risk information must be visible within eyesight on any promotional material - apparently the back of the tent card is like being one-click away on the Internet. DDMAC doesn't buy it.
- November – A dosing sheet for an NSAID includes important risk information from the boxed warning section of the PI, but omits any other risk information associated with the use of the product and instead includes the language "Please see accompanying full Prescribing Information" which DDMAC finds insufficient. Lesson – INCLUDE ALL RISK INFORMATION IN MATERIALS.
Bottom line from this – if the one-click rule does not work on the Internet, it doesn't work in real life either. Don't send people to other places for risk information. Tomorrow, the 7 Warning Letters.