Why is FDA Reopening A Drug-Naming Study Just 3 Months After Issuing New Guidance?
Source:

Beth Snyder Bulik, FierceBiotech

March 16, 2021

The FDA proposes taking another look at drug names, picking up a stalled study to examine the effect of naming on consumer and HCP perceptions.

Drug names often draw curiosity and confusion—and they always get a once-over by the FDA. The agency is more than usually interested these days, though.

After a round of new guidance issued in December, the FDA is dipping back into the issue by reopening a proposed study to determine how drug names influence consumers and healthcare providers.

Its December report “Best Practices in Developing Proprietary Names for Human Prescription Drug Products” includes suggestions for drugmakers and their naming agency partners to avoid misbranding violations.

“A proprietary name, which appears in labeling, could result in such misbranding if it is false or misleading, such as by making misrepresentations with respect to safety or efficacy,” the guidance says, adding “For example, a proposed proprietary name that contains cure or that sounds like cure for a drug that treats the symptoms associated with a chronic disease would be concerning.”

In fact, the re-upped study references that point exactly. The proposed study plans to use the made-up “CureFlux” name as an example of an “extreme and explicitly suggestive” name the FDA will test with patients and healthcare providers.

In all, the study plans to test five made-up name suggestions that vary from the blatant example of CureFlux to more neutral names such as Zerpexin, the new filing for the study reports. The study design also brings drug indications into play, suggesting the agency may be weighing brand names that somehow refer to the way a drug is used.

FDA plans to query 500 consumers and 500 HCPs in the drug name test. The title of the revived study lays out that key FDA concern in its “empirical study of promotional implications of proprietary prescription drug names.”

The study will ask subjects questions about the drug names both before and after they’ve been told what the drug’s indication is. The made-up names, the FDA said, will include “efficacy implications (that) are more apparent than others and some will more clearly imply indication or benefits than others.”

This week’s filing also addressed initial questions and concerns filed during the 60-day comment period last year when the study was first proposed. Seven parties, including Eli Lilly and Bayer, wrote in with their thoughts.

Brand Institute and its Drug Safety Institute regulatory subsidiary was another of the companies that filed comments. Brand Institute is a drug naming heavyweight, partnering on 75% of drug names approved in 2020.

Todd Bridges, global president of the Drug Safety Institute and former director of the FDA’s Division of Medication Errors and Prevention, said the company plans to review the new filing to determine if its initial concerns were answered before deciding whether to file additional comments.

During the name-development process, Brand Institute already asks HCPs whether they think a potential moniker is misleading or promotional. But in light of the FDA’s December guidance, Brand Institute is planning to offer pharma clients an additional set of questions to dig into, Bridges said.

As for the revived study and the new guidance—and what implications they may have for drug naming—Bridges said the FDA may be leaning away from names that refer to a drug’s approved indications. That’s been a fairly common technique in the past though: Consider Sanofi’s influenza shot Flublok or AstraZeneca’s Enhertu treatment for HER2-positive breast cancer.

“If the feedback from the survey comes back that somehow the indication is affecting perceptions in a way they don’t think it should, they may limit how suggestive a name can be of the indication going forward,” Bridges said.

Posted in: Commercial, R&D, Regulatory

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