Dr. Makary has indicated that the FDA will take an aggressive enforcement stance on GLP-1 compounded products as well as action on misleading advertising for such products. He has also indicated that the FDA will take decisive action against compounders that produce copies of approved drug products that do not have a required clinical difference. […]
According to an FDA bulletin (here), “the FDA is sending thousands of letters warning pharmaceutical companies to remove misleading ads and issuing approximately 100 cease-and-desist letters to companies with deceptive ads.” A copy of the letter warning firms to remove misleading ads can be downloaded here. The bulletin says, “The FDA is concerned patients are […]
The FDA has just revised a guidance titled, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers” (here) which says: “This revised draft guidance, when finalized, will describe FDA’s current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. This guidance revises and […]
Today, the FDA released a draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers (here). Try saying that without taking a breath! This draft is a revision of the initial draft guidance issued on February 4, 2020 (85 FR 6201) (the 2020 draft guidance). The […]
I am sure that any of you that have listened to radio or watched TV have heard a prescription drug ad and have struggled with keeping up with the fast talking and not so slow walking people, scene, or scrolling of text on direct-to-consumer ads. FDA has been working to develop standards over the course […]
Just one day after expressing my opinion that more needs to be done to enhance dietary supplement regulations and requirements, I found that the FTC recently revised an older guidance (from 1998) entitled Dietary Supplements: An Advertising Guide for Industry. The new guidance entitled Health Product Compliance Guidance (here), was issued on December 20, 2022 […]
Today, the FDA released a guidance document titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers (here). The document provides the FDA’s responses to eight questions designed to help firms assure that they do not run afoul in advertising or promotion when describing similarities and differences between the […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
In the Federal Register (FR) pre-publication page (here) today, FDA announced a proposed study to evaluate patient/consumer ability to understand the impact of Direct to Consumer (DTC) advertising for products with accelerated approvals. These products are typically approved based on a surrogate endpoint (such as a blood test) that has a reasonable likelihood to predict […]
