Posted: 19 Jan 2017 10:12 PM PST
By Dara Katcher Levy –
After a relatively slow first 11 months of 2016, FDA’s Office of Prescription Drug Promotion (“OPDP”) issued a flurry of letters in the span of 9 days in December, more than doubling the enforcement letters issued up to that point in the year. And the activity on the prescription product communications front keeps coming in 2017, with the following publications issued this week: Draft Guidance on Manufacturer Communications That Are Consistent With The FDA-Required Labeling – Q&A; Draft Guidance on Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Q&A; and an FDA Memo re Communications Regarding Unapproved Uses.
Despite an increase in enforcement activity in December, the type of activity, and the nature of the Draft Guidances issued thus far in 2017 pertaining to prescription product communications indicate a dramatic shift in OPDP’s approach from years past. After a string of First Amendment case losses by FDA, OPDP appears to be picking its battles carefully when it comes to enforcement letters, focusing on omission and minimization of risk (a cornerstone of FDA’s enforcement activity in this area) as well as pre-approval promotion. Of note, FDA’s First Amendment case losses, to date, dealt with issues pertaining to information disseminated about FDA-approved or FDA-cleared prescription products; these cases did not address communications about investigational products for which there were no approvals/clearances. Consistent with that, we have not seen enforcement letters that solely raise issues around efficacy claims for approved products. Letters regarding statements about investigational products, however, are another story.
Of the 11 letters issued in 2016, 4 dealt with pre-approval promotion. Given that only 4 of the 70 letters issued by OPDP between 2012 and 2015 dealt with pre-approval promotion, this dramatic increase signals, to us, a sign of things to come in terms of OPDP’s future enforcement activities.
With regard to already marketed products, as mentioned above, there were no letters issued in 2016 dealing solely with efficacy claims. The few letters that addressed efficacy did so briefly, with a focus, primarily, on the communication of risk information (see our previous post here). The Draft Guidances issued this week reflect this approach - indicating flexibility in FDA’s traditional “substantial evidence” standard to substantiate certain product claims. Stay tuned for our upcoming “deep dive” into these Draft Guidances.
After a relatively slow first 11 months of 2016, FDA’s Office of Prescription Drug Promotion (“OPDP”) issued a flurry of letters in the span of 9 days in December, more than doubling the enforcement letters issued up to that point in the year. And the activity on the prescription product communications front keeps coming in 2017, with the following publications issued this week: Draft Guidance on Manufacturer Communications That Are Consistent With The FDA-Required Labeling – Q&A; Draft Guidance on Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Q&A; and an FDA Memo re Communications Regarding Unapproved Uses.
Despite an increase in enforcement activity in December, the type of activity, and the nature of the Draft Guidances issued thus far in 2017 pertaining to prescription product communications indicate a dramatic shift in OPDP’s approach from years past. After a string of First Amendment case losses by FDA, OPDP appears to be picking its battles carefully when it comes to enforcement letters, focusing on omission and minimization of risk (a cornerstone of FDA’s enforcement activity in this area) as well as pre-approval promotion. Of note, FDA’s First Amendment case losses, to date, dealt with issues pertaining to information disseminated about FDA-approved or FDA-cleared prescription products; these cases did not address communications about investigational products for which there were no approvals/clearances. Consistent with that, we have not seen enforcement letters that solely raise issues around efficacy claims for approved products. Letters regarding statements about investigational products, however, are another story.
Of the 11 letters issued in 2016, 4 dealt with pre-approval promotion. Given that only 4 of the 70 letters issued by OPDP between 2012 and 2015 dealt with pre-approval promotion, this dramatic increase signals, to us, a sign of things to come in terms of OPDP’s future enforcement activities.
With regard to already marketed products, as mentioned above, there were no letters issued in 2016 dealing solely with efficacy claims. The few letters that addressed efficacy did so briefly, with a focus, primarily, on the communication of risk information (see our previous post here). The Draft Guidances issued this week reflect this approach - indicating flexibility in FDA’s traditional “substantial evidence” standard to substantiate certain product claims. Stay tuned for our upcoming “deep dive” into these Draft Guidances.
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