Drug and Device Advertising Review

Navigating FDA and FTC Compliance for Healthcare Promotional Materials

In the highly regulated world of healthcare marketing, drug and medical device companies must navigate a complex web of federal and state advertising laws. Drugs and medical devices are regulated by federal agencies, like the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). By conducting a drug and device advertising review, your company can better protect its business interests.

Whether you’re promoting a prescription drug, an over-the-counter product, a new medical device, or a form of compounded therapy, your marketing materials must comply with strict FDA and FTC standards. Otherwise, you risk warning letters, enforcement actions, and reputational harm. With experienced professional support, you can preemptively address issues before they happen.

Boesen & Snow Law: Reviewing Your Drug and Medical Device Promotional Materials

At Boesen & Snow Law, we work with manufacturers, pharmacies, telemedicine platforms, medical spas, and marketing teams on compliance reviews. In Fiscal Year 2024, the FDA conducted 951 domestic inspections of drugs and issued nearly 400 official action citations.

These citations can impact your business financially, legally, and reputationally. We can help you communicate your product and its purpose effectively to those who need it while minimizing legal exposure.

Our Services

The team at Boesen & Snow Law can assist with several aspects of advertising compliance, from product development to the launch of your product. We can help with:

FDA Advertising & Promotion Compliance

We can help ensure your promotional materials meet the FDA’s requirements under the Food, Drug, and Cosmetic Act (FDCA), including by ensuring the ad has:

• Fair balance between benefits and risks
• Truthful, non-misleading claims
• Proper use of indications, dosing, and safety data
• Adequate substantiation of clinical claims

We can also review labeling, websites, brochures, sales aids, and social media, along with other supplemental promotional materials.

FTC Advertising Compliance

For non-prescription drugs, dietary supplements, and devices, the FTC regulates advertising practices under a “reasonable consumer” standard. We offer guidance to make sure:

• Claims are truthful and not deceptive
• Disclosures are clear and conspicuous
• Endorsements and testimonials meet regulatory standards
• Claims are substantiated with reliable scientific evidence

Pre-Launch and Ongoing Review

We partner with clients at all stages of product development and marketing, and can aid your business with:

• Pre-launch promotional strategy reviews
• Promotional Review Committee (PRC) participation and support
• Review of digital and social media campaigns
• Analysis of direct-to-consumer and HCP marketing materials
• Compliance audits of existing assets

Risk Mitigation and Training

We help teams understand their responsibilities under FDA and FTC rules through:

• Customized compliance training for marketing and medical affairs
• Standard operating procedure development for internal promotional review processes
• Mock reviews to prepare for FDA/FTC scrutiny
• Counseling on response strategies to warning or untitled letters

This support can help your company and employees be compliant and prepared for any potential issue.

Who We Help

We represent a wide range of clients, including:

• Drug and device manufacturers
• Compounding pharmacies and outsourcing facilities
• Telehealth and DTC healthcare startups
• Clinical research organizations and sponsors
• Advertising and PR agencies
• Medical spas and clinics

Why It Matters

It is important that your prescription drug, medical device, supplement, or non-prescription drug complies with the appropriate regulations. Failure to comply with FDA and FTC advertising regulations can result in:

• Warning or untitled letters from the FDA
• FTC investigations and fines
• Loss of public trust or brand damage
• Barriers to product approval or distribution

Our team understands both the legal and commercial realities of promoting healthcare products. We can provide practical and business-minded advice that protects your reputation and keeps your campaigns compliant. By ensuring compliance, you can support your business’s future.

FAQs

Q: What Are the Tasks of OPDP Review?

A: The Office of Prescription Drug Promotion (OPDP) reviews complaints about promotional violations. If a consumer thinks a prescription drug advertisement violates the FDA regulations, then they can submit a complaint to the OPDP. The OPDP also conducts surveillance and review of prescription drug advertisements for compliance and also makes sure the information is not misleading or false. The OPDP can send letters to companies regarding these violations.

Q: Where Is DTC Advertising Legal?

A: Direct-to-consumer (DTC) advertising is legal in the United States, which is one of the very few countries where it is fully legal. However, there still are restrictions and requirements in the U.S. about the information included in DTC advertising. The FDA regulates DTC advertising, requiring that the product advertising be accurate, balanced, and truthful. The OPDP conducts research to determine the relevance and impact of DTC advertising and other advertising that is directed at healthcare providers.

Q: What Are the Ways That Drug Advertising Can Violate FDA Regulations?

A: Drug advertising can violate FDA regulations in many ways, including:

• Making claims about the drug that are unsupported by evidence
• Failure to state or underplay the risks of a drug
• Not having a fair balance of the risks and benefits of a drug
• Saying or implying that the drug can treat something it is not FDA-approved to treat
• Presenting as a disease awareness ad but recommending a specific prescription drug

Some of these violations apply to specific types of DTC advertising.

Q: What Are the FDA Guidelines for DTC Advertising?

A: There are many FDA guidelines for DTC advertising, and these guidelines also depend on the type of drug advertisement. A product claim ad is one that names a drug, describes what it treats, and explains the benefits and risks. It is required to tell you one approved use for the drug, the drug’s generic name, and all risks of using the drug. Other types of ads only give the most important risks.

Getting Skilled Legal Advice and Representation From Boesen & Snow Law

If you need help with drug or device advertising compliance, we can review your materials, train your team, and help you avoid costly regulatory problems.

Reach out today to schedule a consultation.