A FDA Transparency Task Force proposed 21 suggestions to help consumers, industry and others learn how FDA operates and behaves in the manner it does. One of those suggestions was to provide the public with online information about adverse event reports. Though they recommend that such online information should come with a clear disclaimer about the limits of the information, such a database, even if it was updated regularly, could create huge headaches for industry. In slow economic times everyone is looking for ways to work and make money – including plaintiff class action and personal injury lawyers. To allow them to sift through the database may create substantial risk of frivolous but extortive lawsuits. However, this does not mean one should not comply with the rules regarding AERs and, most importantly, have written SOPs on how to maintain a thorough and accurate database of AERs.
Monthly archives for October, 2010
Claims about probiotics helping the digestive system and protecting immunity have been around for decades. However, 2 recent regulatory actions, one involving the FTC and Nestle and the other a warning letter sent from a California District Attorney, show that probiotic claims beyond those traditionally recognized might bring about greater scrutiny. If you are marketing a probiotic product be careful about extrapolating those general claims to ones such as preventing illness and other health claims.
Two recent settlements with the FTC in addition to a NAD review of another company’s advertisement shows that no longer can one rely on inexpensive in vitro, animal tests. Further third party clinical trials or small pilot studies on one’s own products are also risky unless they are rigorous and directly related to the ingredients and the amounts of those ingredients in the product. Recently the FTC entered into consent agreements with Iovate and Nestle products. Those orders required the products in question to have 2 double blind placebo controlled studies for the products. While the FTC stated that these standards only applied to the particular claims and products in the settlement and that the definition of “reliable scientific evidence” is “flexible”, using some old animal or in vitro studies to support your claims will no longer be sufficient. The NAD or National Advertising Division of the Better Business Bureau said this specifically as it pertained to MuscleMeds advertising for its Armatest product. Bottom line, you need rigorous scientific support for your claims. We recommend retaining third party scientific experts to help you conduct that search and analyze your claims and to do so before you being marketing your product and before the regulators come knocking on your door.
As a law firm, we often work with consultants when a client’s needs require both legal and scientific expertise. For instance, if we are preparing a New Dietary Ingredient Notification for a client or a claim substantiation package or an evaluation of the safety and regulatory compliance of a dietary ingredient, the scientific consulting group Innovative Science Solutions, LLC (ISS) is the team of chemists, biologists, physiologists, and toxicologists that we often turn to for their scientific expertise. As an example of the kind of insight that we have come to rely on from ISS, we were interested in their take on the July 29, 2010, British Medical Journal article linking calcium supplements to an increased risk of myocardial infarction. [BMJ - Calcium Supplements and MI] We spoke with David H. Schwartz, Ph.D., head of the Liability Support Practice at ISS about the findings from this study and the implications for individuals taking calcium supplements. (Editorial Comments)
Q: What type of study was this?
A: Actually, it was not original research, but rather an analysis of 11 separate, placebo-controlled clinical trials. This type of analysis across already completed trials is called a “meta analysis.”
Q: What were the investigators looking for?
A: The primary endpoints examined were myocardial infarction, first stroke, and first event for the composite of myocardial infarction, stroke, or sudden death.
Q: And how did they study this?
A: Each individual clinical trial publishes a single number to represent whether each of these events was more likely or less likely to occur with calcium supplementation. These investigators did a statistical analysis on all 11 placebo-controlled trials and determined whether each of the events was more or less likely to occur with calcium supplements.
This weekend, the LA Times ran a story by Andrew Zajac about the “reinvigoration” of the FDA under the Obama Administration (check out the story here). While the focus of the article was food, drugs, medical devices and over-the-counter items (e.g., mouthwash), there’s no doubt that the increased “regulatory activism” is also being expressed toward the dietary supplement industry. While the article cites FDA warning letters sent to companies outside the supplement industry, a similar aggressiveness is being directed in the area of New Dietary Ingredients. Recently, for example, a major sports nutrition company issued a nationwide recall of an anti-aromatase product after receiving word from FDA that the ingredient failed to meet the legal definition required for it to be sold as a dietary supplement. Mr. Zajac’s assessment that “[t]he agency hasn’t gone full throttle yet” may especially apply to dietary supplement products that fall into the category of New Dietary Ingredients. Industry should brace itself for increased scrutiny of products that were not sold in the United States as a dietary supplement before October 15, 1994.