FDA's Office of Postmarketing Drug Risk Assessment is "discouraging" applications that would create a new brand name for an existing active ingredient.

"We have too many trademarks now," OPDRA Associate Director Jerry Phillips told the Food & Drug Law Institute annual meeting April 19 in Washington, D.C. "We need to decrease the number of unnecessary trademarks," Phillips said.

The new policy to discourage multiple brands is spelled out in a Manual on Policy & Procedure that has been finalized but not yet released by the Center for Drug Evaluation & Research. OPDRA expects the MaPP to be released in the near future.

OPDRA is continuing to develop a guidance on drug names, but Phillips now estimates that completion will take "another six months, at least" (¹ Also see "Proprietary Name Evaluation Guidance Will Detail New FDA Review Process" - Pink Sheet, 27 March, 2000.).

"Different names for the same product by the same applicant for different indications and/or dosing regimens will be discouraged," Phillips said. "This is a big issue, one that creates tension I think between the industry and us, where there is a great desire to have multiple trade names for different indications or for a different dosage form." The policy will not affect already approved brands.

Phillips cited the approval of Lilly's fluoxetine for pre-menstrual dysphoric disorder under the Sarafem name.

The agency has received four reports of confusion between Sarafem and Serono's fertility drug Serophene (clomiphene). Phillips acknowledged that "if we had kept with Prozac, we probably would have" had errors anyway, since the agency knows of confusion between Prozac and AstraZeneca's proton pump inhibitor Prilosec (omeprazole). However, "we wouldn't have introduced another set of medication errors by the introduction of a new name."

The new brand name was approved because Lilly "made a strong argument that there was a stigma associated with Prozac and that women would not take Prozac for the disorder," Phillips noted.

"What we are doing with this policy is to raise the bar and say that we have safety concerns with people receiving the same active ingredient by different practitioners" and with the potential for medication mix-ups as brand names proliferate.

FDA also has one report of confusion between Berlex' sotolol brand Betapace and the newer Betapace AF for atrial fibrillation. There was "no clinical outcome to that because they are the same active ingredient, but we did have a patient that was upset that they had received the wrong drug product," Phillips said.

FDA has "anecdotal" reports of patients receiving both formulations of GlaxoSmithKline's bupropion (Wellbutrin for depression and Zyban for smoking cessation), Phillips said. The risk of seizures associated with bupropion increases when overdoses are given.

The MaPP includes a blanket prohibition on using the same brand name for products that contain none of the same active ingredients, Phillips added.

The MaPP will formalize OPDRA's role in providing reviews of brand names for potential safety problems. All proprietary names must be submitted to OPDRA for review, which can occur as early as the end of Phase II. Brand names must also be re-evaluated 90 days prior to the expected approval.

OPDRA reviews will include comments to sponsors to explain the basis for any objection to a proposed brand name. The MaPP specifies that representatives from OPDRA must be included in any meetings between sponsors and FDA over naming issues.

The final decision on trade names will remain with the reviewing division. The MaPP includes a feedback mechanism to insure that OPDRA is informed of any approval decisions that differ from its recommendations, Phillips said.

Under the MaPP, trade names tentatively approved by OPDRA will be posted on FDA's website. The Pharmaceutical Research & Manufacturers of America "worked on" this feature of the MaPP, Phillips noted.

The notice will include the tentatively-approved name, the applicant's name and "the date on which OPDRA found it acceptable," Phillips said. "The purpose of this is to let the industry see what the acceptable names are that are in the pipeline so that they can make more informed decisions on their own trademarks."

FDA Drug Name Policy "Discourages" New Brand Names For Old Ingredients

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