6 Reasons To Hate Drug Naming
Allow me a rant. No, I don't really hate naming drugs. I love it. But I do see drug naming becoming more challenging. Mostly because 2014 has been an insanely transformative year for drug naming. Three major regulatory agencies have proposed, and some have already approved, several new drug naming guidances. The new rules are aimed at establishing higher standards for eliminating medical errors due to confusion or name similarity––without providing greater assurances that the proprietary brand names will be acceptable. It’s a big pill to swallow for biopharma companies, who already confront name rejection rates of up to 50%. The goings-on this year suggest a gearshift for drug naming in 2015:
New Approved Name Guidance from Health Canada––Health Canada (HC) is the first and only regulatory authority (currently) to requiresponsor companies to submit an objective-data report of evidence that their drug name protects consumers from a drug mix-up. Health Canada's new proprietary name guidance, called “Guidance Document for Industry - Review of Drug Brand Names,” finalized in March, ups the ante on data requirements. The new guidance, however, will not become effective until June 13, 2015, so hurry up if Canada is in your drug naming plans.
New Proposed Draft Guidance from FDA––In May the Food & Drug Administration (FDA) posted its proposed “best practices” for naming drugs to help companies navigate through the drug naming process in the U.S. When finally approved (probably in 2015), companies will be required (as in Canada) to put proposed names through much more extensive testing and analysis with Phonetic and Orthographic Computer Analysis (POCA) computational analysis, real-world name simulation studies, and a wide range of “misprescription” testing. Again, start naming activities in the U.S. sooner than later.
EMA New Restriction on Name Requests––The regulatory authority of the European Medicines Agency (EMA) has reduced the number of namescompanies can submit for approval from four to two, putting them on par with other global regulatory agencies. This may sound like a negligible change compared to the more sweeping changes taking place elsewhere, but the implication is a game-changer for some sponsor companies. Wiped out with this ruling is the “global branding” tactic of submitting the maximum four names for the Name Review Group (NRG) meeting in Europe first, in hopes that companies will have (up to) four EMA approved names to select from for submission to the other major regulatory agencies in pursuit of one “global” name.
FDA Public Debate on “Reserving” Brand Names––FDA is "interested in exploring the possibility of 'reserving' proprietary names for companies once the names have been tentatively accepted by the agency." The rationale is to provide greater global brand name certainty, and to avert what’s known in drug naming as the “train wreck scenario.” But by creating its own de facto “trademark office,” FDA will likely have more problems than answers with “reserving” brand names. It will be interesting to see how this stratagem plays out.
Biosimilars Brouhaha––There is currently no U.S. approval pathway for biosimilar drugs. FDA has yet to determine how to classify biosimilars, or whether biosimilar products should bear distinguishable nonproprietary names or not. All this despite a biosimilar under FDA review and a pipeline of biosimilars brewing. Stay tuned.
USAN Is Feeling the Crunch Too–––The United States Adopted Names (USAN) program, which assigns nonproprietary, or generic, names in the U.S., posted this notice on its website:
“ Policy Change: Due to an increase in third party (non-applicant) requests for stem determinations and the resulting increased demand of USAN staff time, the USAN Program will no longer provide potential stem reviews for third party non-proprietary naming consultants who bill their clients for "USAN staff provided" information. USAN Program staff will continue to help and advise USAN applicants directly.”
Not all is lost, however. New Molecular Entity (NME) approvals in the U.S. are up in 2014 with more on the way in the New Year. Cheers.
What are some things that you hate–or love–about drug naming? Let us know here.