Tag: FDA enforcement

FDA enforcement

Regulatory/FDA

Press Release Highlighting Omission of Risk Warning Letter Closes OPDP’s Enforcement Year

Press Release Highlighting Omission of Risk Warning Letter Closes OPDP’s Enforcement Year

Dec. 20, 2019 – As 2019 comes to an end, the FDA’s Office of Prescription Drug Promotion issued its third Warning Letter of the year to Alkermes Inc. for a medication-assisted treatment drug print ad for Vivitrol® and followed that up with an unprecedented press release about the enforcement action on Dec. 11. OPDP also […]

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Regulatory/FDA

Promotion of IND for Brain Cancer Treatment Prompts OPDP Enforcement Letter

Promotion of IND for Brain Cancer Treatment Prompts OPDP Enforcement Letter

Dec. 2, 2019 – In its sixth Untitled Letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP) cited Nascent Biotech Inc. for promoting an investigational new drug (IND) as a safe and effective treatment for brain cancer on its website. This is the second enforcement letter in 2019 to address issues related to […]

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Regulatory/FDA

FDA Amps Up Foreign Inspections Under Pressure to Bend on Opposition to Drug Importation

FDA Amps Up Foreign Inspections Under Pressure to Bend on Opposition to Drug Importation

Sept. 25, 2019 – The traditional position of FDA’s leadership that the importation of foreign medicines is illegal and may pose safety risks to American patients appears to be in conflict with the Trump administration and other politicians who believe importation to be a key element of lowering prescription drug costs. Now, the agency is […]

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Regulatory/FDA

OPDP Warning Letter: Omission of Risk Info in DTC Print Ad/Display Banners Misbrands ED Drug

OPDP Warning Letter: Omission of Risk Info in DTC Print Ad/Display Banners Misbrands ED Drug

Sept. 9, 2019 – In its first Warning Letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP), continues to call out the omission of risk information cited in previous Untitled Letters this year, stating that Metuchen Pharmaceuticals LLC’s direct-to-consumer (DTC) print ad and display banners for its erectile dysfunction (ED) drug include claims […]

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Regulatory/FDA

OPDP Untitled Letter Cites False, Misleading Claims about Efficacy, Risk Presentation for Obesity Drug

OPDP Untitled Letter Cites False, Misleading Claims about Efficacy, Risk Presentation for Obesity Drug

June 19, 2019 – The FDA’s Office of Prescription Drug Promotion (OPDP) has cited VIVUS Inc. for making false or misleading claims about the efficacy of and risks associated with Qsymia capsules, which are intended to be an adjunct treatment for obesity with a reduced-calorie diet and increased exercise, but allegedly were promoted as being […]

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Regulatory/FDA

OPDP Issues Enforcement Letter for Investigational Drug Promotion

OPDP Issues Enforcement Letter for Investigational Drug Promotion

April 30, 2019 – In its first enforcement letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP) asserts that an article posted on a sponsor’s website misbrands the investigational drug “Sodium Acetate C-11” (11-C Acetate) because it suggests in a promotional context that the drug is safe and effective for the purpose for […]

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Regulatory/FDA

FDA Applies Increased Scrutiny to Nutritional Supplements Claiming Pain Relief

FDA Applies Increased Scrutiny to Nutritional Supplements Claiming Pain Relief

March 28, 2019 – “The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health,” the Food and Drug Administration (FDA) states in a new Warning Letter. “Therefore, FDA is taking measures to protect consumers from products that, without approval by FDA, claim to diagnose, mitigate, prevent, […]

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Regulatory/FDA

CDRH Issues Warning Letter for Device Cancer Diagnosis Claims in Brochures, on Website

CDRH Issues Warning Letter for Device Cancer Diagnosis Claims in Brochures, on Website

Feb. 28, 2019 – In a rare promotion-related enforcement action, the FDA’s Center for Devices and Radiological Health (CDRH) issued a Warning Letter to Total Thermal Imaging Inc. (TTI) for claims made about its Thermography Business Package product in the firm’s brochures and on its website. Following an inspection of the firm in summer 2018, […]

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Regulatory/FDA

OPDP Cites Lack of Risk Information in Second Warning Letter of 2018

OPDP Cites Lack of Risk Information in Second Warning Letter of 2018

Nov. 2, 2018 – Providing information about a drug product’s benefits without including any risks is an issue that the FDA’s Office of Prescription Drug Promotion (OPDP) does not take lightly, as evidenced by an Oct. 22 Warning Letter from OPDP to Vanda Pharmaceuticals Inc. This Warning Letter is the second Warning Letter issued in […]

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Regulatory/FDA

Exhibit Booth and Webpage Misbrand IND, OPDP Says in Enforcement Letter

Exhibit Booth and Webpage Misbrand IND, OPDP Says in Enforcement Letter

July 11, 2018 – A booth display and a webpage for the investigational new drug (IND) Crenolanib besylate “suggest, in a promotional context” that the IND is safe and effective for the purposes for which it is being investigated and, therefore, misbrand it, according to an Untitled Letter issued June 28 to Arog Pharmaceuticals Inc. […]

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