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# OPDP Revising Drug Promo Core Launch Reviews
- URL: https://www.fdaweb.com/opdp-revising-drug-promo-core-launch-reviews/
- Published: 2020-11-10T12:00:00.000Z
- Updated: 2026-09-14T16:35:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148053

Beginning next year, CDER Office of Prescription Drug Promotion (OPDP) is revising its core launch review process. “Our goals with these revisions include improving efficiencies, providing timely feedback to firms and maximizing OPDP resources,” acting director **Catherine Gray** told a Food and Drug Law Institute (FDLI) 10/29 virtual conference. The office is hosting a free Webinar 11/20 on the process and interested parties can register [here](https://www.fda.gov/drugs/news-events-human-drugs/office-prescription-drug-promotion-core-launch-review-process-11202020-11202020?ref=fdaweb.com). A recording of the Webinar will be available after the presentation.

According to Gray, OPDP has recently added an option for stakeholders to submit drug advertising and promotional materials through the Center’s next generation portal. She advised those interested to visit OPDP’s electronic common technical document (eCTD) [Web page](https://www.fda.gov/opdp-ectd?ref=fdaweb.com) for instructions.

Gray said OPDP has also recently added a “frequently asked questions” document on the topic of responding to compliance letters in eCTD, and “we strongly encourage folks to submit responses to compliance letters in this format. As always, if you have questions a fantastic \[project management team\] is available to help.” The email for contacting the team is OPDPeCTD@fda.hhs.gov.

Additionally, Gray’s FDLI presentation acknowledged the 10th anniversary of the agency’s “Bad Ad Program.” The program is designed to help health care providers (HCPs) and others recognize potentially false or misleading prescription drug promotion, while also providing them with an easy way to report it to the agency for further investigation. In July, OPDP launched a new continuing education course and [Web site](https://www.fda.gov/drugs/office-prescription-drug-promotion/bad-ad-program?ref=fdaweb.com) for the program, she said. The site includes real life case studies to help healthcare providers recognize false or misleading promotion.

Since 2010, OPDP has received an average of 208 complaints annually, representing roughly a 73% increase in the average number, Gray told FDLI. “The ratio of bad complaints to traditional complaints has steadily increased to 42% of the complaints received to date in 2020,” she said. “Surprisingly roughly 48% of the complaints submitted are by consumers, HCPs submitted around 36% and industry around 12%... We triage all complaints, and send them to the appropriate office for follow up.”

Asked to provide OPDP compliance priorities for 2021, Gray said that the office uses a risk-based monitoring compliance approach with the highest priority given to national public health issues, such as the opioid crisis and Covid-19, and for products approved under a risk evaluation and mitigation strategy program. “And from there we go to products whose labeling included Box Warnings," she said. Other high priority items include launch materials for newly approved drugs, newly approved uses of approved products, products that have been the subject of previous compliance letters, and products cited in complaints.