Posted 20 August 2020 | By
Xeris Pharmaceuticals last week received the first untitled letter sent by the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) in 2020 over claims made in a television ad for its Gvoke (glucagon) pre-filled syringe.
The letter is only the second enforcement letter sent by OPDP this year after the office warned Outlook Pharmaceuticals for omitting risk information in a sponsored link on Google, marking a particularly light year for prescription drug advertising and promotion enforcement activities. (RELATED: OPDP warns pharma company for sponsored link on Google, Regulatory Focus 2 March 2020).
Untitled letter
In the untitled letter, OPDP says Xeris made “false or misleading claims and representations” about the safety and efficacy of Gvoke, which is used to treat severe hypoglycemia in adults and children ages 2 and older with diabetes, in a television ad promoting the product.
According to FDA, the ad in question contains efficacy claims for Gvoke but omits information about its risks, including the fact that the drug is contraindicated in “patients with a known hypersensitivity to glucagon or to any of the excipients in Gvoke.” FDA notes that the ad also leaves out information concerning allergic reactions found in the WARNINGS and PRECAUTIONS and PATIENT COUNSELING INFORMATION sections of the product information.
While the ad states that Gvoke is contraindicated for pheochromocytoma and insulinoma, FDA says the company failed “to include material facts about the consequences that may result from the use of the drug.”
“By omitting these serious risks associated with Gvoke and material facts pertaining to these risks for Gvoke, the TV ad misleadingly suggests that Gvoke is safer than has been demonstrated,” FDA writes.
FDA also takes issue with statements made in the ad about how easy it is to use: “Ease to use. Easy to know you did it right. Pretty easy, huh?” a voiceover says during the ad.
“With regard to ease of use, FDA notes that the DOSAGE AND ADMINISTRATION section of the [prescribing information] PI and the Instructions for Use describe multiple steps involved in the preparation and administration of the Gvoke pre-filled syringe and recommends that users become familiar with these instructions before an emergency happens,” FDA writes, noting that the product does not give any signal to users that it has been correctly administered.
Additionally, FDA says the ad minimizes the seriousness of severe hypoglycemia as it focuses on early, mild symptoms of the condition but leaves out symptoms of severe hypoglycemia, which the product is indicated to treat.
FDA contrasts this statement made in the ad with language found in the Instructions for Use:
Voiceover: “If you have diabetes and take insulin, you know low blood sugar can be scary. You might start to sweat, panic, worry you might pass out. You may even feel like you’re falling.”
Instructions for Use: “If not treated, the patient may progress to severe hypoglycemia, which can include: confusion, seizures, unconsciousness, death.”
In response, FDA calls on Xeris to immediately halt any violative promotional materials for Gvoke and reply to the untitled letter by 28 August stating whether it will comply with the agency’s request and providing a list of its promotional materials for Gvoke that contain violations similar to those mentioned in the letter.
The letter is only the second enforcement letter sent by OPDP this year after the office warned Outlook Pharmaceuticals for omitting risk information in a sponsored link on Google, marking a particularly light year for prescription drug advertising and promotion enforcement activities. (RELATED: OPDP warns pharma company for sponsored link on Google, Regulatory Focus 2 March 2020).
| OPDP enforcement actions (2015-2020) | |||
| Year | Warning letters | Untitled letters | Total |
| 2020 (as of 20 August) | 1 | 1 | 2 |
| 2019 | 3 | 7 | 10 |
| 2018 | 2 | 5 | 7 |
| 2017 | 3 | 2 | 5 |
| 2016 | 3 | 8 | 11 |
| 2015 | 2 | 3 | 9 |
Untitled letter
In the untitled letter, OPDP says Xeris made “false or misleading claims and representations” about the safety and efficacy of Gvoke, which is used to treat severe hypoglycemia in adults and children ages 2 and older with diabetes, in a television ad promoting the product.
According to FDA, the ad in question contains efficacy claims for Gvoke but omits information about its risks, including the fact that the drug is contraindicated in “patients with a known hypersensitivity to glucagon or to any of the excipients in Gvoke.” FDA notes that the ad also leaves out information concerning allergic reactions found in the WARNINGS and PRECAUTIONS and PATIENT COUNSELING INFORMATION sections of the product information.
While the ad states that Gvoke is contraindicated for pheochromocytoma and insulinoma, FDA says the company failed “to include material facts about the consequences that may result from the use of the drug.”
“By omitting these serious risks associated with Gvoke and material facts pertaining to these risks for Gvoke, the TV ad misleadingly suggests that Gvoke is safer than has been demonstrated,” FDA writes.
FDA also takes issue with statements made in the ad about how easy it is to use: “Ease to use. Easy to know you did it right. Pretty easy, huh?” a voiceover says during the ad.
“With regard to ease of use, FDA notes that the DOSAGE AND ADMINISTRATION section of the [prescribing information] PI and the Instructions for Use describe multiple steps involved in the preparation and administration of the Gvoke pre-filled syringe and recommends that users become familiar with these instructions before an emergency happens,” FDA writes, noting that the product does not give any signal to users that it has been correctly administered.
Additionally, FDA says the ad minimizes the seriousness of severe hypoglycemia as it focuses on early, mild symptoms of the condition but leaves out symptoms of severe hypoglycemia, which the product is indicated to treat.
FDA contrasts this statement made in the ad with language found in the Instructions for Use:
Voiceover: “If you have diabetes and take insulin, you know low blood sugar can be scary. You might start to sweat, panic, worry you might pass out. You may even feel like you’re falling.”
Instructions for Use: “If not treated, the patient may progress to severe hypoglycemia, which can include: confusion, seizures, unconsciousness, death.”
In response, FDA calls on Xeris to immediately halt any violative promotional materials for Gvoke and reply to the untitled letter by 28 August stating whether it will comply with the agency’s request and providing a list of its promotional materials for Gvoke that contain violations similar to those mentioned in the letter.
"TV" - Google News
August 21, 2020 at 04:09AM
https://ift.tt/2Yhmm4T
OPDP sends first untitled letter of 2020 to Xeris over Gvoke TV spot - Regulatory Focus
"TV" - Google News
https://ift.tt/2T73uUP
Bagikan Berita Ini
0 Response to "OPDP sends first untitled letter of 2020 to Xeris over Gvoke TV spot - Regulatory Focus"
Post a Comment