Name That Drug: Pharma Balks At FDA Plan
6 CommentsBy Ed Silverman // June 9th, 2008 // 3:44 pm
Suppose you work for a drugmaker and want to call your new pill Havidol. Odds are pretty reasonable that whatever name you choose will get bounced - about 40 percent of chosen names are rejected by the FDA over safety or promotional reasons, The RPM Report notes.
So the agency hopes to improve the odds by transferring responsibility for testing proposed names to drugmakers, the mag writes, adding that, much like the NDA review process, sponsors would test names themselves and submit the info to FDA for approval. Yet there’s still no guarantee the FDA will say okay.
In fact, at a two-day meeting last week, Steve Hartman, a trademarks and copyrights vp at Novartis, noted the new process requires lots of extra work and expressed concern that “predictability will decrease” unless the FDA places added weight on a drugmaker’s efforts.
But Carol Holquist, the director of FDA’s Division of Medication Error Prevention & Technical Support, wouldn’t guarantee anything, other than to say the new process will be more “transparent about the reasons why we’re saying no.” If we learn from those reasons, she added, “the predictability may increase.” In other words, pharma can’t start calling a drug whatever it wants and get a rubber stamp.
Jack2
Havidol: rejected, too close to Haldol.
Bruce Grant
There are actually two different issues over which drug names are typically rejected (or changed after launch).
1. The name is deemed to be confusingly close to that of another drug, creating the potential for prescription errors. E.g., omeprazole was originally launched as Losec,but after a period of time on-market reports began to come in that the name was too similar to Lasix (a commonly used and powerful diuretic) so the name was changed to Prilosec.
2. The name is deemed to constitute a “representation” about the drug’s efficacy, activity, or some other characteristic, which FDA considers a marketing “claim.” Since all claims must be balanced with risk information, and the drug’s name is often seen in contexts which do not provide “fair balance” (quotes used here to indicate terms of art, not to make any kind of editorial comment), this is considered a violation of the Food, Drug & Cosmetic Act. Hence the brand name Regaine, under which the prescription drug minoxidil was marketed for many years in other countries for the treatment of male pattern hair loss, was deemed by FDA to represent an impermissible claim that users would regain lost hair, and thus the name was changed to Rogaine in the US.
Interestingly, FDA vigilance over the second class of brand-name issues has waxed and waned over the years. I remember being astonished when, in the late 1990s, Wyeth received approval to market a new low-dose oral contraceptive (containing less estrogen than many other OCs) as Alesse.
In recent years, however, FDA’s pendulum seems to have swung back to a more aggressive interpretation on this issue. Both Acomplia (rimonabant) and Champix (varenicline) were disallowed by FDA as containing implied claims. Rimonabant, which never made it to market here, would have had to settle for the name Zimulti (which always struck me as more like the name of a pasta…or perhaps a circus act, “The Flying Zimultis”); and the currently ill-starred varenicline is, as only a hermit could be unaware of by now, marketed as Chantix.
Jack2
Lilly’s Adhera (long-acting olanzapine) seems to really walk the line on point 2, and might cross it.
HorusCat
Bruce,
I was going to make your points! But instead, I’ll settle for divulging how reps and doctors laugh at some of these drug names. I have had a few where we just shook our heads and wished the company had paid US a few hundred thou to come up with a better name.
I think the drug-naming wonks should get with the make-up naming folks–OPI nail polish always has great names; so does most lipstick. Of course, “Hot Night at the Villa” could be seen as making a claim…
Lauren
It would be nice if victims of drugs and/or their families were given the privelege (?) to name new drugs. Rather than making a positive claim, the names chosen would be viewed as warnings. Such as: Sicko, Killer, Disgusto, “Little Pink Pill”, Trouble, Danger. LOOKOUT, LIFESHORTENING. Such names would help with our already feeble drug safety efforts, and might make people do some homework before taking the doctor’s word for it. But “Hot Night at the Villa ” could stay. It falls under the recreation category. However, Adhera should have been thrown in the trash.
Doug Bremner MD
Ha ha ha! Here is my comment from a blog I wrote a few weeks ago:
Who comes up with the names of prescription drugs anyway? Take for example the drug
abilify. An antipsychotic drug, the name is apparently meant to represent a new verb
that will stimulate non-functioning mental patients to jump out of their chairs and
start climbing the corporate ladder. Or how about that other anti-psychotic, trilafon?
The makers of this drug were obviously trying to suggest “try laughing”. Obviously
the manufacturers of this pill had never personally experienced the scary delusions
or hallucinations that their pill was meant to treat, otherwise they would have
never made such a zany suggestion. Here’s another one from the antipsychotic category:
Mellaril. I suggest that the marketing people for that drug come up with a
catchy tune with the words “Mellow out with mellaril”. Maybe something from the
Country and Western category?
Lest we think that goofy drug names are restricted to the anti-psychotic class
(whose patrons might be thought to not be able to complain since they were, well… psychotic),
let’s look at asthma drugs. Singulair is obviously meant to imply that you will only
need to take one (single!) drug to get some… air. Well singulair may be making
you want to go out to go out and catch some air since it may be making you, well… nuts.
( (”If they Can’t Kill Us They Might Drive Us Crazy”). Oh, one more from the asthma category:
Serevent. This one is supposed to make us think of “breathing easy” (i.e. “SEREne VENTilation”).
Kind of strange though for a drug that was described as causing patients to “die while
clutching their inhalers”.
Hmmm. Not a very serene thought.