Regulation of Pharmaceutical Marketing: What You Need to Know

After designing, testing, and gaining approval for your drug or medical device, it is time to put the product on the market. Part of this process is the advertising and marketing of your drug or medical device. 

While those who work in marketing might tend to stretch the truth, this is something necessary to avoid in the pharmaceutical industry. There are rules and regulations put forth by the FDA and the FTC (Federal Trade Commission), amongst other federal, local, and industry organizations. 

If any of your promotional materials violate the law, this could lead to huge fines and criminal liability. Your organization would have to handle a disruption in your operations while you deal with inquiries from federal or local officials. 



Understanding the regulations and policies in place that are governing the marketing of drugs and medical devices will help you avoid the above situations, saving you time and money. So what laws are in place governing advertising? And what does enforcement of these laws look like?

The regulations that govern the promotion and advertising of prescription drugs can be found in Title 21 of the Code of Federal Regulations Part 202.

Some of the major requirements found in these regulations are below:

• The uses promoted match what is on the label and consistent with what the FDA approved.
• Any information included cannot be misleading or false.
• If benefit claims or efficacy is included, it must be balanced with information about the associated risks.

The regulations for medical devices, covered by 21 U.S. Code § 352, are very similar to prescription drugs. Your advertisement cannot be false or misleading and should contain only information found on the product labeling that has been previously approved. 

The Federal Trade Commission (FTC) in the US has the responsibility of protecting consumers and competition. They have the authority to go after businesses through law enforcement, advocacy, or education.



The main overlap with the FDA is when companies are promoting any product that makes health claims. The FTC requires that companies support their advertising claims with solid proof.

The FDA monitors advertising and promotion in a few different ways. They will first review promotional materials submitted during the initial dissemination. They then conduct routine surveillance, looking out for any violations of the rules.

The FDA also has a “bad ad program” that works with and educates health care professionals. This way, the professionals know how they can help the FDA ensure that all advertising and promotional materials are truthful. 

If violations are found, the company can receive one of two types of letters. The Notice of Violation (NOV) usually requires the company to stop using the promotional material found in violation. 



The company can also receive a warning letter. This will usually require the company to provide corrective advertising of the false information they put out. This process can be costly for a company, both in cost and reputation. 

For those who work in drug and device advertising, marketing, and promotion, CfPIE is here to help you understand all aspects and actors of the regulation process. Our course “Marketing & Advertising of Pharmaceutical & Medical Devices” will provide attendees with a better understanding of the issues that can affect all marketing and promotional activities. 

Have questions? Get in touch with a member of the CfPIE team by calling 1-610-648-7550 or emailing [email protected].