PhRMA demands an overhaul of FDA's regs on drug names
Frustrated by what drugmakers see as a regulatory snarl of confusing policies and practices aimed at eliminating drug names that can sound too similar to others on the market, lobbyists for the Pharmaceutical Research and Manufacturers of America says it's time for the FDA to either get its act together or lose the power to force companies to come up with new names for their drugs.
Drug developers devote plenty of time to the naming process, searching for a commercial name that can stick in the minds of providers and patients without triggering any confusion with the long list of drugs already on the market--possibly triggering a mix-up at the pharmacy. For developers, any sound-alike names wind up in the FDA's round file and they're sent back to the drawing board. Regulators have been quick to leap on perceived problems, reports Bloomberg, as it did with Risperdal (sounds too much like Requip) and Kapidex (sounds too much like Casodex).
Lobbyists at PhRMA told regulators that the FDA's rules on naming drugs either need an overhaul or they should call a halt, "because there are no validated measures or processes to define or determine when two proprietary names are similar,'' according to the Bloomberg story.
But PhRMA's approach has alarmed the nonprofit Institute for Safe Medication Practices. "The FDA name-testing program provides a crucial safety benefit,'' notes President Michael Cohen. "Without this set of eyes, there is little doubt that the number of serious errors could be far greater.''
- check out the story from Bloomberg