While many advertising agencies, companies, healthcare professionals, and consumers alike may not realize it, the U.S. Food and Drug Administration’s (FDA’s) advertising and promotion laws and regulations apply evenly across brand and generic prescription drug products. From presentation of balancing risk information to submission of all promotional materials to the FDA at the time of initial publication, generic, and brand product companies must carefully adhere to FDA’s requirements for promoting drug products without exception. This, too, means that generic drug makers and marketers can be subject to enforcement action by the FDA, which is why knowing common pitfalls is so important to avoiding regulatory scrutiny and ensuring compliant promotional conduct.

So, what are the most common pitfalls?

Failing to recognize it is promotion and advertising: In many cases, generic drug makers and marketers who prepare print or digital marketing materials for their products may not realize that those materials are subject to FDA’s requirements. In fact, FDA’s list of promotional materials is ever-expanding, reaching more than 40 categories today, from simple product catalogs to social media posts announcing the launch of a generic drug.

Forgetting to submit it to the FDA: All promotional materials and advertisements (no matter the form) must be submitted to FDA at the time of initial publication or dissemination on Form FDA-2253. There is no exception for generic drug related materials and failure to submit constitutes noncompliance with law.

Excluding the required bells and whistles: Promotional materials and advertisements featuring a drug’s uses generally must include certain elements, including the FDA-approved indication, risk information, manufacturer name and address, and accompanying full Prescribing Information. Failing to include any risk information, for example, or failing to present the full indication have been cited in warning letters involving generic drug promotion in recent years. Since the full product indication must be presented under FDA’s authorities without omitting material information, FDA has objected to generic drug promotion that paraphrases the product’s indication by omitting important qualifying information, resulting in a misleading or overbroad indication statement.

These pitfalls can result in FDA enforcement letters for generic drug promotion. Because these letters are posted publicly—and so many generic drug makers are public companies—receiving an enforcement letter from FDA can raise investor and shareholder concern and is best to be avoided. Remember to approach the preparation of even the simplest generic drug promotional materials as you would brand drug materials. FDA will be doing the same and public enforcement action is on the line.

  • Julie Tibbets

    Julie Tibbets is a FDA Partner in the Technology & Life Sciences Group at Goodwin. Julie advises manufacturers and marketers on product promotion, disease awareness activities, and corporate communications. Since 2016, Julie has been listed in the Best Lawyers in America for FDA law.


    You May Also Like

    A CRO’s Role in Driving Development to Match Market Demands

    Patients, physicians, payers, and pharma all see Comparative Effectiveness Research from different perspectives. Well-designed ...

    ELITE 2018 Disrupter Tyler James of Snow Companies

    Tyler James Senior Vice President, Video Production Snow Companies Revolutionizing Patient Films Tyler James ...