FDA Considers Letting Branded Drugmakers Reserve Names
The FDA is considering letting branded drugmakers reserve a proprietary name for a new product, with the goal of avoiding potential delays by approving permanent drug names well in advance of product launch.
The agency floated the idea in a Federal Register notice, calling for comments on how the program should be structured. The FDA also wants to get an accurate sense of how the current system has affected product launches.
Currently the FDA provides tentative approval of a drug name during product development, usually after a Phase II trial is completed. Final approval comes when the drug is fully approved by the agency. The FDA retains the authority to revoke tentative approval of a name for various reasons, such as the entry of another product with a confusingly similar name, the agency said, which would leave drugmakers seeking a new name for a product after it was already approvable.
The FDA’s request for comment includes calls for:
- Examples of drug launches that were delayed because the agency’s determination on the drug’s name came too close to the date of product approval;
- The conditions a drugmaker should meet before a name is reserved, and how long it is reserved;
- Whether participation in the program should be mandatory or voluntary; and
- If the program should extend to OTC products.
The initiative is an outgrowth of the agency’s effort to address the problem of similar proprietary names — which can sometimes lead to medication errors — since it became a performance goal in the 2007 reauthorization of PDUFA IV.
Earlier this year, the FDA released draft guidance on how drugmakers should evaluate potential names. The agency recommended manufacturers avoid names that include specific attributes, dosing information, symbols or the company’s own name. — Robert King
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.