In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and team member, Genevieve M. Razick give an overview of FDA’s Office of Prescription Drug Promotion's (OPDP) enforcement of unlawful advertising in 2020.
Each...more
New Year. Same Types of Issues. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued its first Warning Letter of 2021, and it identified many of the same types of unlawful promotional...more
Good riddance to 2020 for so many reasons. But, as the AGG Year in Review of the Food and Drug Administration’s enforcement of prescription drug advertising and promotion has become an annual ritual, let’s take a quick peek...more
Instead of sending a turkey and cranberry sauce, in the spirit of 2020 where nothing is normal, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) made a different delivery this year for...more
Some of us remember radio stations playing two songs from the same artist or band, back to back, with the alliterative “Two for Tuesday” slogan. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP)...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more
On August 31, 2020, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent a Warning Letter to the sponsor of a drug for a violative direct-to-consumer (DTC) radio advertisement.1 The radio...more
AGG recently presented a webinar on “FDA Regulation of Rx Drug and Medical Device Advertising & Promotion: The Year in Review.” The webinar focused primarily on an in-depth review of the enforcement letters issued by FDA to...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
On November 1, 2019, the Food and Drug Administration’s (FDA)Office of Prescription Drug Promotion (OPDP) sent an Untitled Letter to the sponsor of an investigational new drug that is being studied to treat brain cancer. ...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
On September 13, 2019, FDA’s Office of Prescription Drug Promotion (OPDP) issued a Warning Letter stating that a professional email made false or misleading claims and representations about the risks and effectiveness...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) recently sent an Untitled Letter to the manufacturer of a weight-loss drug for its Internet promotion. ...more
AGG recently presented a webinar on “FDA Regulation of Rx Drug and Medical Device Advertising & Promotion: The Year in Review.” The webinar focused primarily on enforcement letters and three guidance documents issued by the...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
In its 1990 hit, “Enjoy The Silence,” Depeche Mode sings, “Words are very unnecessary, they can only do harm.” The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
FDA’s Office of Prescription Drug Promotion (OPDP) issued only five letters in 2017 (compared to eleven in 2016 and nine in 2015). This relatively slow year left some prescription drug manufacturers wondering if, to quote the...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing...more
The Food and Drug Administration recently issued holiday gifts, in the form of enforcement letters, to four pharmaceutical companies. The letters are reminders that FDA is not in a partying mood when it comes to unlawful...more
The Food and Drug Administration’s Office of Prescription Drug Promotion didn’t take the summer off, despite the uncertainty surrounding any new enforcement action relating to off-label promotion. Specifically, OPDP recently...more
On March 29, 2016, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to a pharmaceutical company for a patient co-pay assistance voucher that failed to include risk...more