Using AI in pharma marketing can be powerful—but risky.

You might use ChatGPT or another AI tool to help write emails, patient materials, or campaign ideas. But if you're in pharma, your content has to pass through Medical, Legal, and Regulatory (MLR) review. And AI can easily break those rules if you're not careful.

This guide breaks down the top risks when using AI for copy—and how you can stay compliant while still moving fast.

The Big Problem: AI Makes Things Up

AI is great at writing quickly. But it doesn’t always know what it’s talking about.

It can:

• Make up fake studies
• Say things your drug isn’t approved for
• Skip safety language
• Use incorrect medical terms

In pharma, that’s not just sloppy—it can lead to regulatory violations, rejected content, or worse.

Industry leaders have warned that generic AI tools, while fast, often "sound confident" even when the facts are wrong. This tendency to fabricate studies or clinical claims can lead to unintentional off-label messaging and serious regulatory issues.

Why It Matters: MLR Reviews Are Tough

MLR teams check every word in your campaign. They make sure:

• All claims are backed by data
• No off-label use is suggested
• Safety information is included
• The format follows legal rules

And here’s the catch: AI doesn’t know your label, your market access rules, or what your legal team allows.

If your AI-generated copy gets flagged, your team could waste weeks reworking it.

A recent Solomon Partners report found the average pharma asset takes 29 business days to get through MLR. So errors are expensive.

Top 5 AI Copy Risks in Pharma

1. Fake Claims or Off-Label Statements

AI often “hallucinates” facts. It might say your drug helps with something it’s not approved for. That’s a major red flag (FDA guidance).

2. Missing or Wrong Citations

AI may make up a study, reference the wrong one, or leave out citations completely. In pharma, every claim needs proof (EMA reflection paper).

3. Skipping Safety Information

AI might highlight benefits but forget side effects. That breaks the FDA’s “fair balance” rule (FDA DTC Promotion Rules).

4. Breaking Format or Legal Rules

It could drop required text like "Indications" or use language your brand isn’t allowed to use (e.g. "best-in-class").

5. Privacy and Data Problems

If you use AI on real patient data, you might violate HIPAA or GDPR rules. Never upload personal health info into AI tools unless they’re approved for that use (HHS Guidance).

What Regulators Say

The FDA and EMA have made it clear: AI doesn’t get a free pass.

AI content is still held to the same standards as anything else:

• Truthful
• Balanced
• Backed by real data
• Properly formatted

The FDA’s January 2025 draft guidance says: you must keep records of how AI content was made and who reviewed it (source).

So you can’t just hit “generate” and go live. You need to be able to show:

• What prompt was used
• Where the data came from
• Who approved the final version

How to Stay Compliant: Simple Steps

✅ 1. Train AI on Approved Materials

Don’t let it guess. Feed it past MLR-approved language, templates, or fact sheets. That way, it learns how your brand communicates safely.

✅ 2. Write Clear Prompts

Tell the AI what not to do:

• "Only use approved data."
• "Do not suggest uses beyond what the label says."
• "Include safety info."

Guidance from Anthill Agency stresses the need to box in your AI with these rules.

✅ 3. Scan AI Drafts Before MLR

Some pharma teams are using “AI compliance copilots” that scan drafts before MLR review. Pfizer’s team, for example, uses AI to pre-flag red flags in medical claims (CrowdPharm 2024).

✅ 4. Save Everything

Always keep the original prompt, AI response, and edits. If legal asks where something came from—you’ll have the answer.

✅ 5. Never Skip Human Review

No AI should replace your MLR reviewers. Use AI to move faster—but not to skip steps.

✅ 6. Keep It Fresh

Retrain your AI tools when your label changes. Don’t rely on old data or outdated copy.

Where This Applies

AI can help across many pharma marketing areas—as long as you follow the rules.

Digital Strategy & Analytics

Use AI to:

• Personalize emails
• Segment HCPs
• Forecast market trends

But always double-check that insights don’t suggest off-label uses.

Medical Communications

AI can help draft:

• Patient brochures
• Slide decks
• FAQs

Just be sure all facts are verified, and citations are real.

UX & Campaign Execution

AI can rewrite content for:

• Email
• Social
• Web

Just make sure required disclaimers and fair balance appear in every format.

Strategic Planning

AI can help model:

• Launch curves
• Channel mix
• HCP engagement trends

But legal and regulatory teams should review how these models are used in strategy.

Market Access

AI can translate or localize content across regions. But teams must ensure nothing is lost in translation—especially risk language.

The Bottom Line

AI can make pharma marketing faster. But it also makes mistakes. Big ones.

If you want to use AI safely:

• Feed it trusted inputs
• Set up guardrails
• Keep human reviewers in the loop
• Track what it generates

Compliance must come first.

CI Life works with pharma brands to ensure AI tools support—not break—your MLR process.

If you’re wondering how to safely use AI for marketing copy, let’s talk.

Learn more about how CI Life supports compliant content workflows.