Avoiding Post-Approval FDA Scrutiny: Drug Marketing Materials

While securing approval from the U.S. Food and Drug Administration (FDA) is a major milestone in the process of bringing a new drug to market, this is not the end of the road when it comes to federal compliance. Drug manufacturers (and other companies) have a multitude of post-approval obligations—including obligations related to the marketing of their medical products.

Marketing Violations Can Present Substantial Risks

A recent untitled letter from the FDA makes this clear. The FDA sent the letter to Mirati Therapeutics, Inc. (“Mirati”), which recently secured FDA approval for its non-small cell lung cancer drug, Krazati. In the untitled letter, the FDA states that Mirati’s website “makes false or misleading claims and representations about the benefits of Krazati . . . [and t]hus, the website misbrands Krazati within the meaning of Federal Food, Drug, and Cosmetic Act (FD&C Act).”

As the FDA’s untitled letter goes on to state, the violations identified by the FDA, “are particularly concerning because the [website] makes misleading representations about the efficacy of Krazati in patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) . . . [which] is an incurable condition with a 5-year survival rate of less than 10%.”

Avoiding Marketing Violations Post-Launch

Facing allegations of non-compliance from the FDA can severely impact business operations and the resulting rework can be expensive. With this in mind, what can (and should) drug companies do to avoid marketing violations post-launch?

The key is to take a collaborative approach to developing drug marketing materials. This approach should involve not only the company’s marketing department, but also its subject matter experts and legal counsel. Subject matter experts will be able to help ensure that data about a drug’s effectiveness are not being misrepresented or presented in a misleading way—though they will still need to rely on the company’s legal counsel to assess any potential FDA implications.

One of the keys to using clinical data for drug marketing purposes is substantiation. When making data-based claims, drug companies need to ensure that they have adequate data on hand to support them. If relevant data are not available to support a claim, then the claim should not be made. Implied claims, such as claims of effectiveness or comparisons to other drugs, should be avoided absent data to support, as the FDA, and your competitors, will treat these no different than express claims. By working with their legal counsel to evaluate marketing materials before they go public, drug companies can substantially mitigate their risk of receiving untitled letters that require them to pump the brakes on their marketing efforts.

Get Help from the FDA Regulatory Team at Gardner Law

If you have questions about drug marketing compliance—or any other aspect of FDA compliance—we invite you to get in touch. Contact us to speak with a member of the FDA regulatory team at Gardner Law today.