It is always important to look back and see what FDA's DDMAC is producing in the way of objections to promotional materials and practices communicated by medical manufacturers. In Part 1 of the examination of the third and fourth quarter of 2009, we take stock of the quantitative aspect for the Warning and Notice of Violation letters issued by DDMAC.
There were indications early in the year that DDMAC enforcement might be turning around from the plunge that occurred over the previous eight years. That, however, did not happen. One has to assume that either DDMAC is enforcing regulations with less vigor than in previous years, or companies have gotten much, much better at keeping in line. Talk amongst yourselves.
While the numbers represent an increase for this year – to 38, when one strips out the unusual circumstance (to say the least) of the single day of 14 letters surrounding paid search issued on April 2, then the number of enforcement actions by DDMAC falls to a very undramatic 24.
And speaking of mass mailings, the FDA's Office of Compliance on November 16, 2009, sent out 22 letters to various entities regarding Internet Marketing of Unapproved and Misbranded Drugs. There were none sent out at all during the rest of the year. It appears the FDA stored up all the violations for that single day of enforcement. The FDA began to issue letters to Web sites that sold prescription drugs and dietary supplements on line illegally under the category of the badly named "Cyber letters" – a practice that began in 2000, but appears to have fallen into disuse by 2009 when no such letters were issued. These Cyber letters used to include warnings from CDER and from CFSAN for drugs and dietary supplements, respectively. It is not clear whether CDER is now going to include these enforcement actions within it's own Warning Letter system or not, but the 22 letters were not listed as Cyber letters. No word on where CFSAN will post its own warning letters regarding dietary supplements. In all, very confusing sorting on the part of the FDA regarding an important and increasingly emerging issue involving the purchase of medical products on the Internet.
Obviously, you’d have to look at each individual warning letter to see if DDMAC was taking a more aggressive stance (a qualitative vs. quantitative evaluation).
You noted the slight uptick in warning letters and wondered why enforcement hadn’t increased to 1990’s levels. One of the reasons could be that FDA is still in process of determining what represents “fair balance”. Another reason could also be related to FDA’s shift to risk-based actions. Due to a lack of resources, FDA has focused its efforts on the most harmful violations.
We’ll see if this trend holds.
Yep, that is true about the qualitative aspect. I will be going thru the letters and providing an overview of their content in Part 2, but it won’t be going back and comparing them to previous years. As to the downsurge and lack of resources – I don’t have inside info on resources, but it would seem that the influx of PDUFA dollars should have resulted in more resources, not less, unless I’m missing something.
You are missing something. PDUFA-sourced funds are generally earmarked for reviewing activities, not for enforcement activities.
Ah! Many thanks!