A Drug by Any Other Name
Experts think FDA's new drug name approval processs is a work in progress. Could packaging help?
An attempt to streamline FDA’s name approval process for new drugs has prompted responses. In June, FDA accepted feedback from industry leaders for its Pilot Program to Evaluate Proposed Name Submissions to consider new terms for approval.
The proposed changes would place the responsibility of researching drug names with the pharmaceutical company. Once testing has been completed, the companies would present their research to FDA for review and approval.
Representatives from Medical Error Recognition and Revision Strategies (Med-E.R.R.S.) participated in the public meeting to discuss FDA’s draft concept paper. The Institute for Safe Medication Practices, the parent group of the for-profit Med-E.R.R.S., also spoke. FDA accepted written responses to the proposal until late July.
“We’re not sure that FDA’s ‘new’ way will be any better than the practice that companies are now using,” says Susan Proulx, Med-E.R.R.S. president. “As of now, the methodology used is based on opinions, albeit expert ones. The new way will continue to be based on opinions. FDA will be looking at the old way and comparing it with the new way. They will decide which is better, based on the opinion of their evaluators in the medication safety group.”
Similarities in drug names can put a new name at risk for rejection. After months or years of testing, this can derail a thoroughly researched name. Packaging could differentiate between similar names and address this problem.
“You want names to minimize similarity, but you can’t eliminate it completely, so you’re left with the label to make it distinct,” says Bruce Lambert, PhD, department of pharmacy, and administration director, center for education and research on therapeutics, University of Illinois at Chicago. “You’re left with bolding, highlighting, etc.”
With a process that some groups deem overcomplicated, several package prototypes could be required on the route to approval. Otherwise, the role of pharmaceutical packagers will change little with these new guidelines.
“Now, that’s a mistake, you might say,” Lambert says, whose research includes the effects of packaging on drug compliance. “I think it’s really, really important to think about labels. Issues about how the name should be featured—picture, font size, etc.—those issues don’t come up in this new policy.”
“Medication use errors occur due to sound-alike or look-alike names, unclear labels, or poorly designed packaging,” according to the Institute of Medicine report To Err Is Human—Building a Safer Health System.
Medication errors in regard to trademarks could affect a company whose packaging is blamed for misapplication.
“The stakeholders and FDA expressed the opinion that there is no gold standard for testing proprietary drug product names to assess the risk of error,” admits FDA in its draft concept paper.
The proposal draft includes details on the new procedure, which emphasizes company research. “The goal under PDUFA [Prescription Drug User Fees Act] IV is to develop and implement a pilot program that would enable participating pharmaceutical firms to evaluate proposed proprietary names and submit the data generated from those evaluations to the Centers for review. Using best practices when carrying out their own proprietary name reviews and providing FDA with the resulting data may help ensure that pharmaceutical firms are able to choose appropriate proprietary names for their products.”
“I think the jury is still out as to what the best way is at this point,” Proulx says of the name approval process. “That’s why we want to explore different options in addition to what was suggested at the June meeting.”
A concept paper that will describe the pilot and the proprietary submissions to be included in it is due to be available at the end of fiscal year 2008. The pilot will conclude in 2011.