FDA Recordkeeping Requirements for Business Communications: What Pharma Companies Must Retain

Short Summary

The FDA’s Office of Prescription Drug Promotion closely regulates formal promotional material aimed at healthcare providers. However, a growing share of what pharma sales reps actually say to providers happens over text messages and WhatsApp, informal channels that carry the same regulatory risk but receive none of the same review. This guide explains what FDA oversight covers, where the recordkeeping gap exists in day-to-day rep communication, and what DOJ’s ECCP guidance now expects companies to be able to produce if an investigation arises.

Key Takeaways

• OPDP requires formal review before use: The Office of Prescription Drug Promotion requires every promotional communication about a prescription drug to be submitted for review according to a specific timeline and process.
• Missing the deadline counts as not submitting at all: Failing to meet the required submission deadline can be treated as seriously as never submitting the material for review.
• Messaging app communications carry equal weight: Texts, WhatsApp messages, and other informal exchanges about drugs are subject to the same regulatory standards as formal promotional material, yet pharma companies rarely screen them or are able to produce them if a review is required.
• Off-label and unsupported claims often surface informally: Messages sent over apps and texts frequently contain off-label references or other risky claims, creating legal exposure for the company.
• Unrecorded conversations create risk: Most pharma companies don’t record conversations on messaging apps. If a rep’s message is never captured, the company has no way to review, correct, or explain it during an audit or investigation.
• Pharma companies need full visibility: To meet FDA and DOJ expectations, pharma companies must have the infrastructure to capture and archive rep communications wherever they happen, including on messaging apps.

What FDA Oversight Covers

Prescription drug marketing in the United States operates under close, continuous regulatory oversight. Those responsible for FDA communication recordkeeping within pharma companies must understand current OPDP regulations and their implications.

The Office of Prescription Drug Promotion (OPDP), a division within the FDA’s Center for Drug Evaluation and Research (CDER), exists to ensure that prescription drug promotion is truthful, balanced, and not misleading. It carries out ongoing surveillance of promotional activity, reviews complaints from healthcare professionals and competitors, and issues warnings when promotional communications cross the line into false or misleading territory.

OPDP’s core functions include:

• Reviewing promotional materials before and after use: In addition to reviewing commercials and journal ads, OPDP also looks at sales aids, leave-behinds, exhibit booth panels, and digital content.
• Investigating complaints: OPDP reviews and evaluates any complaint received from healthcare providers, competitors, consumers, or law firms about potentially misleading promotion.
• Issuing enforcement letters: OPDP sends Untitled Letters and Warning Letters when materials violate fair-balance or accuracy standards. Untitled Letters cite less serious violations and give a company the chance to correct course without further action. Warning Letters signal more serious violations that may lead to formal enforcement if not promptly corrected, and become part of the public record. 
• Monitoring live promotional activity: OPDP representatives attend medical conferences and review materials such as pamphlets and booth displays in person.
• Running the Bad Ad Program: OPDP runs an outreach initiative that trains healthcare providers to recognize and report misleading promotions themselves. Anyone can submit a report anonymously, and the reports go directly to OPDP, not through the company.

FDA enforcement activity has intensified considerably in recent years. The FDA issued over 200 enforcement letters challenging drug advertising and promotion in 2025, compared to just five each in 2023 and 2024.

Messages sent from reps’ personal devices are subject to the same scrutiny as formal promotional material, yet pharma companies rarely screen or record these conversations in a way that is retrievable for compliance purposes. This is a risky practice that invites regulatory exposure, and companies need full visibility into communications across all devices and messaging channels in order to protect themselves.

Given the level of scrutiny, pharma compliance teams need strong FDA communication recordkeeping practices and detailed knowledge of applicable regulations so they can equip their organizations with the right tools and procedures to meet all compliance obligations.

The Key FDA Communication Recordkeeping Regulations Pharma Companies Need to Know

Compliance obligations for pharma marketing are spread across regulations governing what must be submitted, when, and how promotional claims must be balanced, each with its own deadlines and failure points.

The Fair Balance Standard

Under 21 CFR § 202.1, every promotional communication about a prescription drug must present risk and effectiveness information with comparable thoroughness. The regulation sets out twenty specific ways a communication can be considered false, lacking in fair balance, or otherwise misleading, including:

• Overstating efficacy: Presenting a drug as more effective than has been demonstrated by substantial evidence.
• Minimizing risk language: Presenting risk information with less prominence, detail, or readability than the effectiveness claims it accompanies.
• Unsupported comparisons: Suggesting a drug is safer, more effective, or has fewer side effects than a competing treatment without data to support the claim.

Sales representatives often use messaging apps to communicate, typing messages that are typically unscripted and personal rather than reviewed in advance like a formal ad. Because the fair balance standard applies to these informal communications just as it does to approved materials, companies need a way to capture and review rep communications across every channel they actually use.

The Submission Deadline: Form FDA-2253

21 CFR § 314.81(b)(3)(i) requires pharmaceutical companies to submit samples of advertising and promotional labeling to OPDP according to strict deadlines and protocols:

• The deadline is the moment of first use: Companies must submit each piece of promotional material at the time it is first disseminated, meaning the date a representative first shows the material to a healthcare provider. Promotional materials include sales aids, brochures, websites, social posts, and physician presentation slides.
• Every submission requires Form FDA-2253: Each submission must include a completed Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use), accompanied by a copy of the product’s current professional labeling.
• A separate form is required for each item: If a single campaign uses a brochure, a website page, and a slide deck built around the same core message, each of those three pieces still needs its own Form FDA-2253 submission.
• Missing the deadline constitutes a violation: Failure to meet the submission deadline can render the product misbranded under Section 502(n) of the Federal Food, Drug, and Cosmetic Act, regardless of whether the material’s content was accurate.

These formal submission requirements apply only to the formal promotional materials listed above, not to informal communications via text messaging and other messaging platforms. When a sales representative communicates with a healthcare provider about a drug over these channels, the content of that communication is never submitted to OPDP and never reviewed against the fair balance standard. However, the underlying fair balance and misbranding rules still apply to what is actually said, regardless of channel, creating a compliance gap where some of the riskiest communications are the least visible.

The Recordkeeping Gap in Digital Rep Communication

Regulators and the Department of Justice have increased their examinations of informal follow-up communications, including text messages, WhatsApp conversations, and emails between representatives and healthcare providers. Investigators evaluate whether these informal communications stayed within the boundaries of the filed material or introduced claims, comparisons, or off-label statements that were never submitted for review.

When these exchanges contain the following elements, they can create unintended violations that invite legal and regulatory consequences:

Off-label Promotion

This refers to the promotion of a specific drug for a condition, dosage, or patient population that the FDA has not approved. Physicians often prescribe drugs off-label at their own discretion, but a company actively promoting that use, even informally, risks misbranding the product under the Federal Food, Drug, and Cosmetic Act.

When a representative promotes an off-label use to a healthcare provider, that communication falls outside the FDA’s approved boundaries for the product. This often happens inadvertently, such as when a representative sends a text message confirming that “some providers are prescribing it for [unapproved condition] too.” 

A message like this, sent over a messaging app or text, carries the same regulatory exposure as a formal off-label claim in a printed ad. However, because these messages are spontaneous and sent in the moment from a personal device, they are not submitted to the FDA for review under Form FDA-2253 and therefore reach the healthcare provider unchecked, with no opportunity for legal or regulatory review to catch a problematic claim before it is made. If the message later surfaces during an investigation, the company has no record of having reviewed or corrected it, which can compound the underlying violation.

Unapproved Claims

Any statement that overstates efficacy, downplays risk, or makes an unsubstantiated comparison to another treatment falls outside the fair balance standard. A representative telling a provider over text or WhatsApp that “it works faster than the alternative,” without data to support the claim, creates the same fair balance exposure discussed earlier.

Other Risky Communications

Other types of informal rep communication carry similar risks, including sharing incomplete or selectively favorable safety data, citing unpublished or preliminary clinical results as established findings, and forwarding promotional material that was never submitted under Form FDA-2253. 

Each of these can create regulatory exposure when communication occurs on a messaging app rather than in a filed document, since none of it undergoes the review that formal promotional material receives before reaching a healthcare provider.

Why This Gap Persists

The pharmaceutical industry has an established review process for formal promotional material, governed by the fair balance standard under 21 CFR § 202.1 and the Form FDA-2253 submission requirement under 21 CFR § 314.81(b)(3)(i). This process applies to written and produced materials such as sales aids, brochures, journal ads, and websites. Messaging app communications, by contrast, have no equivalent checkpoint, even though their content is equally subject to the same compliance obligations and can just as easily surface a violation if screened. 

Given how widespread messaging apps have become as a preferred mode of business communication, the resulting gap in oversight creates a serious pharma sales communication compliance risk, where a significant and growing share of communications most likely to cause compliance issues are never reviewed before they cause harm.

What DOJ’s ECCP Expects From Pharma Compliance Programs

The Department of Justice (DOJ) applies a different set of pharma sales communication compliance expectations than those enforced by the FDA. While the FDA’s OPDP focuses on the content of formal submissions, the DOJ typically investigates allegations of off-label promotion through its Consumer Protection Branch and fraud connected to sales and marketing practices through its Fraud Section, which pursues False Claims Act cases tied to drugs billed to Medicare and Medicaid. Because these are separate legal grounds from the FDA’s own enforcement authority, a DOJ investigation can proceed alongside or independently of an FDA action.

When the DOJ evaluates whether to bring charges against a company, or how to resolve a case once charges are on the table, it does so against the Evaluation of Corporate Compliance Programs (ECCP). The ECCP sets out the questions federal prosecutors ask when judging a company’s compliance program, namely whether it is:

• Well designed
• Properly resourced
• Functioning in practice rather than existing only on paper

For recordkeeping purposes, the most important question is whether a compliance program works in practice. A pharma company may have a written compliance program stating that sales representatives must not discuss off-label uses over text or WhatsApp, but if that policy is not actually followed day-to-day by company reps, it will not satisfy the DOJ.

Prosecutors want to know whether reps are trained on the policy, whether anyone checks that it is being followed, and whether anything happens when it is broken. A policy that exists on paper but that reps ignore, with no one checking, will be treated by the DOJ as if there were no policy at all. Practically speaking, this means pharma compliance officers need to be able to prove a policy is being followed, with records to back it up. Without visibility into what reps are actually sending to healthcare providers, they cannot prove this with confidence.

DOJ’s guidance has become increasingly specific about what that proof needs to look like, particularly where personal devices and messaging apps are involved:

• Personal devices and messaging apps are included in the DOJ’s evaluation: A pharma company’s policies governing sales representatives’ use of personal phones, texting, and third-party messaging apps such as WhatsApp, Signal, and Telegram are now a factor prosecutors weigh directly, given how often these are the channels reps actually use with healthcare providers.
• A written policy is not sufficient on its own: The DOJ specifically evaluates whether the company can access and produce the underlying data from those platforms, not merely whether a policy prohibiting off-label discussion on WhatsApp exists on paper.
• The policy has to be consistently enforced: The DOJ treats a retention or communications policy that exists on paper but is inconsistently followed as functionally equivalent to having no policy at all.
• The compliance function itself needs data access: Compliance personnel and tools must have adequate access to communications data to carry out their functions. A compliance team with no visibility into what representatives are actually sending to healthcare providers is a weakness the DOJ can identify.
• Preservation obligations begin before an investigation is confirmed: Once litigation or investigation becomes reasonably foreseeable, relevant records, including informal rep-to-provider messages, must be preserved and made available for eDiscovery rather than lost to auto-delete settings, ephemeral messaging features, or an employee leaving the company or switching devices.

Closing the Recordkeeping Gap in Pharma Communication

To fully meet DOJ compliance and FDA communication recordkeeping expectations, pharma companies need recordkeeping practices that cover every channel a sales representative might use, not just the ones formally submitted under Form FDA-2253. This requires a governance approach that can capture informal conversations without disrupting how reps and providers actually communicate.

The LeapXpert Communications Platform enables pharmaceutical companies to capture and archive rep communications across text messaging, WhatsApp, and other consumer messaging apps, giving compliance teams the visibility OPDP oversight and DOJ’s ECCP guidance both expect. The platform keeps a complete, time-stamped record of these conversations, giving compliance and legal teams the evidence they need for audits, investigations, and regulatory requests, thereby closing the gap between what is formally submitted to the FDA and what is actually said in the field.

Book a demo to learn more.

FAQs

Does the FDA require companies to retain sales rep text messages?

The FDA’s formal recordkeeping requirements center on promotional material submitted via Form FDA-2253, which does not explicitly cover informal rep communications such as text messages. However, if a text message or WhatsApp exchange constitutes promotional communication about a drug, including responses to questions about efficacy, safety, or use, it falls under the same FDA recordkeeping pharma obligations as formal promotional material. Separately, the DOJ’s ECCP guidance expects companies to have a compliance program that can capture these records if an investigation arises. 

What happens if a pharma company can’t produce a record during an FDA inspection?

An inability to produce a requested record during an FDA inspection can itself become a compliance finding. This holds true regardless of whether the underlying communication proves problematic. Inspectors can document the gap as a formal finding in the inspection report, which the company must then respond to.

If the missing record relates to promotional material, it can also factor into an OPDP referral, an Untitled Letter, or a Warning Letter, since an unrecorded rep conversation may be evidence that the company cannot show it stayed within its approved claims. The absence of a record is not neutral; it is itself a data point regulators use to evaluate a company’s compliance program.

Are personal messaging apps like WhatsApp a compliance risk for pharma reps?

Yes. Personal messaging apps can pose risks because they typically sit outside the channels a company can monitor, review, or produce records from upon request. A rep using WhatsApp to answer a provider’s question informally usually has no way to capture that response or make it retrievable later.

This is a problem specifically because DOJ’s ECCP guidance expects companies to be able to produce a full record of these conversations if an investigation arises, and an unrecorded WhatsApp exchange cannot be produced. To reduce this risk, pharma companies need a capture and archiving solution capable of recording messages and metadata across the apps reps actually use, applying configurable retention periods, supporting legal holds, and exporting records into existing archiving and surveillance systems.