Tag: FDA enforcement

FDA enforcement

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 […]

Read more

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 […]

Read more

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 […]

Read more

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 […]

Read more

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, […]

Read more

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, […]

Read more

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 […]

Read more

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. […]

Read more

Regulatory/FDA

False/Misleading Risk, Efficacy Claims in Online Video Cited in OPDP Enforcement Letter to Pfizer

False/Misleading Risk, Efficacy Claims in Online Video Cited in OPDP Enforcement Letter to Pfizer

July 2, 2018 – The FDA’s Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter in 2018 to Pfizer Inc., claiming that a direct-to-consumer (DTC) video for the ESTRING® (estradiol vaginal ring), posted on the michiganmomliving.com site, as well as prepared Q&As provided to interview participants (and submitted to the agency under Form […]

Read more

Regulatory/FDA

CBER’s APLB Issues First Enforcement Letter Since 2015 for Misleading Efficacy Claims

CBER’s APLB Issues First Enforcement Letter Since 2015 for Misleading Efficacy Claims

March 7, 2018 – The Center for Biologics Evaluation and Research’s (CBER’s) Advertising and Promotional Labeling Branch (APLB) may not exactly be an enforcement powerhouse, issuing just three Untitled Letters since 2013, but it found fault with CSL Behring LLC’s Website, patient brochure, exhibit panel and sales aid for IDELVION® because these promotional materials allegedly […]

Read more