FDA Enforcement
New Warning Letter from DDMAC
10/23/09 09:11
FDA issued a
warning letter
to King Pharmaceuticals for a Video News Release
(VNR) for their extended release opioid EMBEDA. It
was posted on FDA's website yesterday. The letter is
interesting for a number of reasons:
FDA's concerns about EMBEDA in the warning letter stem from both the omission of the acknowledgment of the potential for fatality related to the risks and to the fact that the materials promote the uniqueness of the product formulation that is designed to reduce the abuse potential for this opioid. According to FDA, this formulation is designed to reduce abuse potential it has not been shown (by substantial evidence) to reduce abuse potential. The other important note is that FDA continues to be concerned about risk communication in any type of promotional material and in any type of media. In this case, it was not so much the media but the content of the message itself that FDA had a problem with. With respect to the media, it is only interesting in that FDA made no exceptions as to the message regardless of whether it was a VNR or press material as opposed to typical promotional material. This is not a new way of thinking for FDA, but its always interesting to point these issues out when they arise. Also, as I cover information about FDA enforcement actions, its always worth noting that FDA's perspectives and telling of the facts were all that was available to me.
- The opioid class is subject of an unprecedented class wide mandatory REMS due to the significant risks of extended release opioid use including risks of abuse and diversion. Products in this class are an ongoing concern for FDA and DDMAC, because of the obvious public health concerns. FDA has issued multiple warning letters on products in this class over the years, mostly due to concerns of omitting or minimizing risks of opioids. Most noteworthy are FDA's warning letters for Oxycontin which ultimately resulted in a large settlement with the DOJ and state Attorneys General in cooperation with FDA a few years ago. Its interesting that FDA emphasizes the REMS in the warning letter to highlight its concerns about the safety communications for EMBEDA. The proposed FDA REMS includes typical REMS components, a communication plan and elements to ensure safe use that specifically concern the information that is allegedly omitted or minimized in the VNR that was cited.
- According to the letter, there were prior discussions between the company and FDA, in which the company apparently agreed to take corrective action on the material, yet FDA still issued the warning letter to the company. FDA sometimes exercises discretion and witholds issuing warning letters where companies cooperate in taking correcting action proactively. Nonetheless, once the information is disseminated FDA can issue enforcement regardless of the level of cooperation of the company. Where these concerns are of a public health nature, FDA is possibly less likely to exercise favorable discretion.
- The subject of the enforcement action is a video news release. An ongoing issue with the press materials, including press releases and video news releases, is whether or not they are promotional materials (and subject to FDA's promotional regulations) or they are non-promotional in nature and disseminated under 21 CFR 312.7, a provision under the IND regulations that allows for non-commercializing communications about prescription drugs in which FDA will not exercise its authority over promotional materials and advertising. There are additional arguments that such materials deserve some special 1st Amendment protections or are required under SEC disclosure requirements (and consequently should not be considered promotional). However, there's plenty of precedent for FDA enforcement in press materials, particulary where FDA considers these to be false or misleading in any way. The fact that material is meant for press or media purposes is a trivial obstacle (if any at all) where FDA finds an item to be false or misleading and/or where FDA considers the item to raise public health concerns.
FDA's concerns about EMBEDA in the warning letter stem from both the omission of the acknowledgment of the potential for fatality related to the risks and to the fact that the materials promote the uniqueness of the product formulation that is designed to reduce the abuse potential for this opioid. According to FDA, this formulation is designed to reduce abuse potential it has not been shown (by substantial evidence) to reduce abuse potential. The other important note is that FDA continues to be concerned about risk communication in any type of promotional material and in any type of media. In this case, it was not so much the media but the content of the message itself that FDA had a problem with. With respect to the media, it is only interesting in that FDA made no exceptions as to the message regardless of whether it was a VNR or press material as opposed to typical promotional material. This is not a new way of thinking for FDA, but its always interesting to point these issues out when they arise. Also, as I cover information about FDA enforcement actions, its always worth noting that FDA's perspectives and telling of the facts were all that was available to me.
0 Comments