Alan G. Minsk

Dec 20, 2024 | jdsupra.com | Alan G. Minsk

While the authors are not huge fans of the rock band Def Leppard, its 1983 “Photograph” hit came to mind recently, when we read a recent Warning Letter issued, in part, because of a company’s refusal to allow photographs during an FDA inspection.1 We have written in the past about companies’ refusal to allow, or make difficult, an FDA investigator’s ability to access certain records or files during an inspection.2 It is not only a bad idea, but it is also a prohibited act.3 However, one does...

Nov 20, 2024 | jdsupra.com | Laura Dona |Alan G. Minsk

Peter Murphy’s 1989 single, “Cuts You Up,” came to mind when we read FDA’s Office of Prescription Drug Promotion’s (“OPDP”) latest Notice of Violation.1 OPDP issued the NOV to a company for its unlawful promotion of its prescription biologic, indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.2 The agency took exception to Instagram posts by the company and its celebrity...

Sep 20, 2024 | jdsupra.com | Laura Dona |Alan G. Minsk

In 1984, the international rock band, The Scorpions, released the song, “Rock You Like a Hurricane.”1 Forty years later, the Food and Drug Administration’s Office of Prescription Drug Promotion rocked a pharmaceutical company with a migraine when it recently issued a Notice of Violation for unlawful promotion. Here, in its fourth NOV issued this year, OPDP found the company made false and misleading claims in a television advertisement for a prescription migraine pain product.

Aug 15, 2024 | jdsupra.com | Laura Dona |Alan G. Minsk

Much like how Ray Charles lamented in 1967, the pharmaceutical industry is saying, “Here we go again, she’s back in town again,” as the Food and Drug Administration issued its second Notice of Violation in a month.1 Last week, FDA’s Office of Prescription Drug Promotion issued an NOV to a pharmaceutical company regarding misleading claims made on its branded website intended for healthcare professionals.2 The company’s website was brought to the agency’s attention through its Bad Ad Program.

Aug 7, 2024 | jdsupra.com | Laura Dona |Alan G. Minsk

In 1987, the influential garage rock band, The Replacements, led by Paul Westerberg, sang, “I can’t hardly wait.” Years later, the Food and Drug Administration issued a Notice of Violation — the second this year — to a pharmaceutical company for unlawful promotion, when it found that the company’s celebrity spokesperson posted on her personal Instagram account about the company’s prescription drug product but did not include any safety information.1 While there was a link to click for more...