OPDP: FDA's Office of Prescription Drug Promotion

OPDP stands for the Office of Prescription Drug Promotion. It is the office in FDA's Center for Drug Evaluation and Research (CDER) that reviews prescription drug advertising and promotional labeling. FDA's Office of Medical Policy page lists it among its areas. OPDP's stated mission is "to ensure that prescription drug promotion is truthful, balanced, and accurately communicated" through "comprehensive surveillance, compliance, and education programs."

Companies deal with OPDP through Form FDA 2253 filings, requests for advisory comments, and the untitled and warning letters it sends when it finds a piece false or misleading.

What OPDP regulates

FDA's Bad Ad Program page says OPDP regulates prescription drug promotion made by or on behalf of the manufacturer, packer or distributor. That covers TV and radio advertisements, written and printed materials, internet promotion including social media, speaker program presentations and sales representative presentations. Promotion must not be false or misleading, must balance efficacy and risk information, and must reveal material facts about the product.

The same page lists what OPDP does not regulate and who handles it.

FDA's guidance on promotional submissions is written for both offices: OPDP in CDER and APLB in CBER. The Form 2253 instructions send drugs and therapeutic biologic products to OPDP and "biologics" to CBER's Document Control Center. FDA's pages do not list which biological products go where.

What OPDP does

OPDP's own page lists the work of its reviewers: written comments to sponsors on proposed promotional communications, review of complaints about alleged violations, compliance letters on false or misleading promotion, comparison of the labeling and promotion of closely related products, and travel to major medical meetings to monitor exhibits. It also runs a social science research program and publishes a quarterly bulletin, The Brief Summary, started in January 2022.

• Filings. Applicants send each promotional piece on Form FDA 2253 at first use, under 21 CFR 314.81(b)(3)(i). OPDP received 80,043 submissions holding 172,476 materials in fiscal 2026. See the Form FDA 2253 guide.
• Advisory comments. 21 CFR 202.1(j)(4) lets any advertiser send a draft for comment before publication. OPDP's FAQ says pre-approval of promotional materials "is not required except in rare instances." For core launch materials FDA's goal is comments within 45 days, after a 5-business-day screening period.
• Complaints. The Bad Ad Program takes reports at BadAd@fda.gov or 855-RX-BADAD. OPDP's goal is to acknowledge each complaint within 30 calendar days.
• Letters. An untitled letter or a warning letter names the piece, quotes the claims and asks the company to stop using them. See the untitled letter entry.
• Guidance. OPDP's regulatory information page collects FDA's guidances on promotion. The ones issued since 2023 are in the table below.

The numbers OPDP publishes

FDA's OPDP Metrics page, current as of 2 November 2026, shows its figures as chart images.

The first four rows are transcribed from FDA's charts. The last is our count. Our post on materials submitted versus letters published gives the five-year series and its caveats. FDA publishes no figure for the share of filed pieces that a reviewer reads.

The 2025 enforcement change

On 9 September 2025 FDA announced a crackdown on deceptive drug advertising. Its release said FDA was "sending thousands of letters warning pharmaceutical companies to remove misleading ads," issuing about 100 cease-and-desist letters, and starting rulemaking on the "adequate provision" option for broadcast ads (see FDA's plan to end adequate provision). It also said warning letters to pharmaceutical companies had dropped to one in 2023 and zero in 2024.

Most of those letters are not public. The published record shows 5 untitled letters in 2024, 63 in 2025 (52 of them dated 9 September) and 25 in 2026 through 26 October. You can search all 120 untitled letters and 25 warning letters in our OPDP letter search. The analysis of what they cited found overstated efficacy in 67% of the untitled letters.

Guidance issued since 2023

The December 2023 guidance explains a final rule published in the Federal Register on 21 November 2023 (88 FR 80958). The rule took effect on 20 May 2024, with a compliance date of 20 November 2024. The payor communications draft appears on FDA's guidance search and the Federal Register, but not on OPDP's news page, which FDA lists as current as of 16 September 2025.

OPDP and APLB

CBER's Advertising and Promotional Labeling Branch does for certain biological products what OPDP does for drugs. It takes their promotional submissions, and the Bad Ad Program page sends reports about them to APLB. OPDP's FAQ says its 5-business-day core launch screening period was built for OPDP submissions. For APLB or CDRH products, it says to contact those offices directly. Some of the letters in our dataset come from CDER or CBER rather than OPDP, because FDA has filed promotion warning letters under different offices over the years.

The MLR review entry covers how companies check pieces against these rules before they are filed.