Mapping the regulatory landscape that governs your promotion, MBA Training, MBA Training
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Mapping the regulatory landscape that governs your promotion
# Mapping the regulatory landscape that governs your promotion
In 2010, a company promoted a cholesterol drug for uses the FDA had never approved. The settlement: $3 billion. Most of that penalty was not about the science. It was about the marketing: sales reps, ads, and speaker programs that made claims outside the approved label.
That is the stakes. In biotech and medtech, a single sentence in an ad can trigger regulatory action, product seizure, or a fraud settlement. Before you write copy, you need to know which rulebook governs your claim, in which geography, on which channel.
This lesson maps the four bodies you will meet most often: the FDA, the EMA, the FTC, and the EU MDR.
The core principle: your claim must match your approval
Every regime below shares one idea. You can only promote a product for what regulators have authorized, supported by evidence they accept.
Two terms you will use constantly:
On-label: promoting a product for the use, population, and dose the regulator approved. Legal.
Off-label: promoting for an unapproved use. Illegal to promote, even if doctors may legally prescribe that way.
The famous $3 billion case was off-label promotion. Keep this distinction in your head as we go.
FDA: the US gatekeeper for drugs and devices
The FDA (Food and Drug Administration) regulates prescription drug and medical device promotion in the United States. The relevant office is
OPDP
(Office of Prescription Drug Promotion), which reviews drug advertising.
The governing rule: promotional material must be truthful, not misleading, and fairly balanced. Fair balance means if you state the benefits, you must give comparable prominence to the risks.
Concrete examples:
A DTC (direct-to-consumer) TV ad for a prescription drug must include the major risks (the "major statement") and a way to find full prescribing information. The US is one of only two countries that permit prescription drug DTC advertising at all (the other is New Zealand).
A pharma tweet that lists a drug's benefit but omits risk is a classic violation. In 2014 the FDA issued draft guidance specifically about character-limited platforms.
A medtech firm cannot market a device cleared only for diagnosis as if it also treats a condition.
When the FDA sees a problem, it issues an Untitled Letter (a nudge) or a Warning Letter (serious). Both are public. You can browse real ones in the FDA Warning Letters database, which is a goldmine for learning what crosses the line.
Two device pathways that change your claims
510(k) clearance: the device is "substantially equivalent" to an existing legally marketed device. You may only claim what that equivalence supports. You cannot say "FDA approved." Correct phrasing: "FDA cleared."
PMA (Premarket Approval): the high-risk pathway (for example, implantable devices). Here "FDA approved" is accurate.
Getting the verb wrong ("approved" vs "cleared") is a real compliance error marketers make.
FTC: the consumer-protection layer
The FTC (Federal Trade Commission) polices advertising for products the FDA does not tightly control, and shares jurisdiction in some areas. In practice, the FTC is your rulebook for:
Dietary supplements and wellness products
OTC (over-the-counter) products, alongside the FDA
Health apps and consumer wearables that are not regulated devices
The FTC standard: claims must be substantiated by competent and reliable scientific evidence. For a health claim, that usually means well-designed human clinical studies, not testimonials.
Examples the FTC has pursued:
Supplement brands claiming to cure or prevent disease without trials.
A health app claiming it detects a condition without evidence.
Misleading "clinically proven" language where the study did not support it.
The FTC also enforces rules on endorsements. If a biotech pays or gifts an influencer to promote a wellness product, that relationship must be clearly disclosed. See the FTC Endorsement Guides for the current standard.
EMA and national agencies: the European drug picture
The EMA (European Medicines Agency) approves many medicines centrally for the EU. But here is the twist marketers miss: the EMA does not directly police advertising. Advertising enforcement happens at the national level.
Each member state applies Directive 2001/83/EC, the EU's core medicines law. National agencies (for example, the MHRA in the UK post-Brexit, or BfArM in Germany) and industry self-regulation bodies enforce it.
Key differences from the US:
No DTC advertising of prescription drugs. In the EU it is banned. You can advertise prescription medicines to healthcare professionals only. This single rule reshapes your whole channel strategy versus the US.
Advertising of OTC medicines to the public is allowed but tightly controlled.
Industry codes, such as the EFPIA code (European Federation of Pharmaceutical Industries and Associations), add self-regulatory rules on top of law, including transparency on payments to doctors.
So the same launch may run a Super Bowl-style patient ad in the US and be strictly professional-only in Germany.
EU MDR: the device rulebook in Europe
The MDR (Medical Device Regulation, EU 2017/745), fully applied since 2021, governs medical devices in the EU. It replaced the older Medical Device Directive and raised the bar significantly.
For marketers, the critical MDR provision is Article 7, which restricts claims. You may not:
Use text, names, or images that mislead the user about the device's intended purpose, safety, or performance.
Suggest uses or performance the device does not have.
Imply a device is safer or more effective than the evidence supports.
A device sold in the EU carries a CE mark (Conformité Européenne), showing it meets MDR requirements. Your claims must stay inside the device's certified intended purpose. Market a CE-marked fitness tracker as a medical heart monitor, and you have an Article 7 problem plus possibly an unapproved medical device problem.
A practical decision mapmapUsing software to automate repetitive marketing tasks and campaigns, enabling personalisation at scale across channels like email, web, and social.View full definition →
Before writing a claim, run these questions:
1. What is the product? Drug, device, supplement, or app. This picks your primary regulator.
2. What geography? US (FDA/FTC) or EU (national agencies under EU law, plus MDR for devices).
3. Who is the audience? Patients/consumers or healthcare professionals. In the EU, prescription DTC is banned outright.
4. What channel? TV, social, email, sales rep, conference booth. Character-limited channels have specific FDA guidance.
5. Is the claim on-label? If it goes beyond the approval, stop.
🎬 [VIDEO: "FDA Regulation of Prescription Drug Advertising" - youtube.com - clear overview of how OPDP reviews DTC and professional promotion]
Knowledge check
1. A physician legally prescribes a drug for a use the FDA never approved. A sales rep then promotes the drug for that same use. Which statement best captures the regulatory situation?
2. The large settlement described in the lesson was driven mostly by marketing conduct rather than the science of the drug. What core principle does this best illustrate?
3. An FDA DTC television ad states a drug's benefits but mentions its major risks only briefly at the very end in fine print. Which principle is most directly violated?
MULTIPLE CHOICE
4. Select ALL correct answers about the concept of on-label versus off-label promotion.
Select all the correct answers.
MULTIPLE CHOICE
5. Select ALL correct answers about why mapping the regulatory landscape matters before writing promotional copy.
Select all the correct answers.
Worked example: one product, two continents
Imagine a company launching a CE-marked and FDA-cleared continuous glucose monitor (a wearable that tracks blood sugar).
US plan:
Regulator: FDA (device is 510(kkThe average number of new users each existing user generates through referrals. Above 1.0, growth compounds on itself and becomes exponential.View full definition →) cleared).
Verb check: say "FDA cleared," never "FDA approved."
Audience: patients and clinicians both allowed.
Channel: DTC digital ads permitted, but risk information required.
Claim boundary: only the cleared intended use. No claim it "prevents diabetes complications" unless the clearance supports it.
EU plan:
Regulator: national authorities under MDR; the device carries a CE mark.
Article 7 check: no misleading claims, stay within the certified intended purpose.
Audience: patient advertising allowed for devices (unlike prescription drugs), but still cannot overstate performance.
Claim boundary: performance claims must match the technical documentation reviewed for CE marking.
Same device, two compliance workflows, different permitted language.
Pre-launch compliance checks
Build these into your marketing calendar before any campaign goes live:
Medical/legal/regulatory (MLR) review: a formal internal sign-off where medical, legal, and regulatory staff approve every promotional piece. Standard in pharma. Budget weeks, not days.
Claims matrix: a document listing each claim and the exact evidence and label section that supports it.
Verb and pathway audit: cleared vs approved, on-label vs off-label.
Geography split: separate approved copy per market, since a US-legal ad may be illegal in the EU.
Disclosure check: influencer and endorsement relationships flagged per FTC rules.
Key Takeaways
Match every claim to the approval. On-label is legal; promoting off-label is the single most expensive marketing mistake in this sector.
Product plus geography plus audience picks your regulator. FDA and FTC in the US; national agencies under EU law plus MDR for devices in Europe.
The US allows prescription DTC advertising; the EU bans it. This one rule forces different channel strategies per market.
Get the verb right: "FDA cleared" (510(kkThe average number of new users each existing user generates through referrals. Above 1.0, growth compounds on itself and becomes exponential.View full definition →)) is not "FDA approved" (PMA), and misusing it is a real violation.
Run MLR review and a claims matrix before launch. Study real FDA Warning Letters to see exactly where peers crossed the line.
This lesson is educational and not legal advice; consult qualified regulatory counsel for specific campaigns.