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# OPDP Outlines Drug Promotion Priorities
- URL: https://www.fdaweb.com/opdp-outlines-drug-promotion-priorities/
- Published: 2021-01-25T12:00:00.000Z
- Updated: 2026-09-14T16:44:02.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5148511

CDER’s *Office of Prescription Drug Promotion (OPDP) says its regulatory attention in 2021 will focus* on promotional materials involving high-risk drugs like opioids. “We want to make sure the promotional materials accurately convey the risks associated with these drugs, convey responsible use of opioids, and do not inadvertently contribute to the opioid epidemic, OPDP acting director **Katie Gray** says in a new [CDER posting](https://www.fda.gov/drugs/news-events-human-drugs/opdp-reflects-2020-looks-forward-2021-it-helps-ensure-prescription-drug-promotion-truthful-balanced?ref=fdaweb.com). “We also prioritize drugs approved under a [Risk Evaluation and Mitigation Strategy](https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems?ref=fdaweb.com) and other drugs with labeling that include Boxed Warnings regarding potentially serious side effects.”

OPDP will continue its focus on promotional activities with drugs used for treating Covid-19, Gray notes. “OPDP will continue to help make sure that promotional materials for drugs intended to prevent or treat Covid-19 are accurate. And we will continue to target promotional materials that falsely suggest that a drug has been approved for Covid-19 when it has not.”  

Other high-priority OPDP areas this year include first impression launch materials for newly approved drugs, new uses for approved therapies; products that have been the subject of previous compliance letters; and drugs cited in complaints to the agency or promoted in far-reaching campaigns, Gray says in the posting.

OPDP also plans this year to “put more of a human face on our work,” according to Gray. “We want firms, health care providers, patients, and the lay public to better understand what we do. We want to be more visible in our work with industry to make sure patients and prescribers receive accurate information about the therapies they use and prescribe. With that in mind, we plan to have more OPDP staff participate in the [DIA Advertising and Promotion Regulatory Affairs Conference](https://www.diaglobal.org/en/conference-listing/meetings/2020/03/advertising-and-promotion-regulatory-affairs-meeting?ref=fdaweb.com) so that industry can put a face with the name of the person or people reviewing their materials... We are also working on additional policy, regulatory and social science agendas. Please stay tuned to see what we release in the year ahead.”

Gray says that the Covid emergency has advanced OPDP’s electronic acceptance of promotional materials from drug marketers. “We have moved away from paper and are accepting electronic submissions through an additional online portal,” she says. “The six-inch paper stacks of background information are becoming a thing of the past; references, correspondence and promotional materials can now be submitted electronically. After the pandemic, I see OPDP continuing to take advantage of technology to make things simpler and faster for our staff and the firms we work with.”

Additionally, Gray suggests OPDP is content with the **status quo** regarding social media promotional activities. “Surprisingly, social media has not been much of a game changer for us,” she says in the posting. “Yes, there are different types of (and more) promotional materials, but we use the same approach when we review these materials for truthful and non-misleading benefit and risk presentations. Firms still need to fulfill FDA regulatory requirements; it doesn’t matter what the platform is. Last year, we enforced these requirements in two Warning Letters concerning sponsored links, which are advertisements that appear on a search results webpage. In addition, we have issued [four guidances](https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/industry-using-social-media?ref=fdaweb.com) pertaining to social media. We continue to consider these and other social media topics as we work, more broadly, to develop policy about prescription drug promotion.”