2016 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

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Food, Drugs, and Devices the proprietary name to describe an investigational product contributed to the suggestion that the product has been approved by FDA. 4. Lack of Adequate Directions for Use One letter (to Supernus) focused on the promotional piece’s lack of adequate directions for use. Generally, such allegations concern the lack of information regarding the safety and efficacy of a product for certain uses. According to OPDP, the video at issue in the Supernus letter suggested that the drug was intended for use in all seizure types, when in fact the drug was indicated only for partial seizures. Although the video described the correct indication in scrolling text and a voiceover, OPDP noted that placement of the indication after the main presentation did not negate earlier statements. Previously OPDP typically categorized similar allegations under the heading “Broadening of Indication.” More recently, OPDP began to describe these presentations as lacking adequate directions for use. OPDP has not provided a rationale for the change, but it could be motivated by a desire to tie the alleged violation more closely to the statutory requirement that labeling contain “adequate directions for use.” 8 CBER Office of Compliance and Biologics Quality (OCBQ) Enforcement Activity FDA’s Office of Compliance and Biologics Quality (OCBQ) did not issue any enforcement letters in 2016 relating to advertising and promotion. This continues a recent downward trend in enforcement letters that began in 2013, when the office issued only three letters total. This was a decrease from previous years. In particular, between 2008 and 2012, OCBQ issued between five and seven letters each year. In 2015, OCBQ posted only one untitled letter, related to an influenza vaccine. 9 Covington discussed the letter in a previous client alert. CDRH Office of Compliance (OC) Enforcement Activity The Office of Compliance (OC) in FDA’s CDRH did not post any enforcement letters relating to advertising and promotion on FDA’s website in 2016. Summaries of OPDP Letters This information below merely summarizes the allegations contained in FDA’s enforcement letters. It does not contain any analysis, opinions, characterizations, or conclusions by or of 8 21 USC § 502(f). 9 Untitled Letter to Protein Sciences Corporation re: Flublok (Influenza Vaccine) BLA STN # 125285 (March 12, 2015), available here. 8
Food, Drugs, and Devices Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients. Hospira Untitled Letter (January 2016) OPDP found that a YouTube.com video promoting Hospira’s drug Precedex (dexmedetomidine HCI Injection) was false or misleading because it omitted risks and material facts about the drug. Omission of Risk Information: The video contained numerous efficacy claims, but failed to include any risk information associated with Precedex. Additionally, the video alluded to arousability, but it was presented as a benefit (i.e., how Precedex is “different” from other sedatives), instead of as a warning or precaution, as described in the PI. OPDP found that this omission of risk information created a misleading impression about Precedex’s safety. Omission of Material Fact: The video made representations about the use of Precedex for intensive care unit sedation, but failed to communicate material information about the drug’s indications and use. Specifically, Precedex is indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting and should not be used continuously for more than 24 hours. FDA alleged that the video omitted material facts by failing to note these limitations. Failure to Submit Under Form FDA-2253: FDA alleged that a copy of the video was not submitted to OPDP at the time of initial dissemination in violation of 21 CFR 314.81(b)(3)(i). Shionogi Warning Letter (March 2016) OPDP contended that a “Patient Co-Pay Assistance Voucher” for Ulesfia (benzyl alcohol) lotion for topical use was false or misleading because it omitted important risk information and omitted material facts. Omission of Risk Information: The voucher made representations about the efficacy of Ulesfia, including that the drug is “the #1 prescribed banded Rx treatment for head lice,” but failed to communicate any risk information. OPDP noted that the voucher included statements such as, “For more information, please refer to the package insert for full prescribing details…”, but OPDP found that such statements did not mitigate the omission of risk information from the voucher itself. Omission of Material Facts/Inadequate Communication of Indication: OPDP further alleged that the voucher failed to communicate a limitation of use contained in Ulesfia’s indication, namely that it does not have ovocidal activity. In addition, the voucher failed to adequately communicate that Ulesfia is indicated only for patients six months or older. Although the “Dear Pharmacists” section at the bottom of the back page contained information about the indication, OPDP said that this presentation did not “mitigate the misleading impression.” Failure to Submit Under Form FDA-2253: FDA alleged that Shionogi violated 21 CFR 314.81(b)(3)(i) by failing to submit a copy of the voucher to OPDP at the time of initial dissemination. 9
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2016 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

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