Category Archives: DTC Advertising

HHS Proposes Pricing in DTC

In May the Administration released a plan called “America’s Patients First” , a blueprint to lower drug prices and reduce out-of-pocket costs. One of the items contained in that blueprint was to have the manufacturers of medicines include the list … Continue reading

Posted in DTC Advertising, FDA Policy | Tagged , , , | Comments Off on HHS Proposes Pricing in DTC

DTC and OPDP

It is a different era of enforcement. So far the first quarter of 2017 has not yielded a single regulatory action letter from the Office of Prescription Drug Promotion (OPDP). That said, in December of 2016 OPDP put out more … Continue reading

Posted in DTC Advertising, Warning Letters | Comments Off on DTC and OPDP

Health for Sale – What Would DDMAC Do?

Last week I was fortunate enough to catch a segment of the PBS News Hour that featured a new exhibit at the Philadelphia Art Museum called “Health for Sale“.  The exhibit is comprised of the direct-to-consumer (DTC) of yesteryear – … Continue reading

Posted in DTC Advertising, Miscellaney, Uncategorized | Comments Off on Health for Sale – What Would DDMAC Do?

MAD Doctors! FDA Deputizes Docs to do DDMAC Ad Reviews!

 "Paging Dr. Draper!  Paging Dr. Draper!  We have an ad in the examination room that requires your attention, STAT!"  The PA system goes quiet.  In the waiting room, patients shuffle their feet nervously, waiting, waiting, waiting…. Dr. Draper enters the … Continue reading

Posted in DTC Advertising, FDA Policy, Warning Letters | 3 Comments

FDLI Conference – Part 2 – Janet Woodcock Speech

At the opening of the 20th Food and Drug Law Institute Conference Annual Advertising and Promotion Conference, CDER's Dr. Janet Woodcock stood in for Dr. Margaret Hamburg who was said to have had a scheduling conflict due to a meeting … Continue reading

Posted in DTC Advertising, FDA Policy | Comments Off on FDLI Conference – Part 2 – Janet Woodcock Speech