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Volume 4, Issue 3 UPDATE-ERR™ Autumn 2011

President's Message

Dear Med-ERRS Friends and Colleagues,

Some of you may have seen the letter dated June 27, 2011 from the Pharmaceutical Research and Manufacturers of America (PhRMA) to the Division of Dockets Management at the FDA submitting comments “regarding FDA’s review of existing regulations to determine whether they can be made more effective in light of current public health needs and to take advantage of and support advances in innovation.” (see links below for additional information.)

The section of the letter to which I specifically refer is that relating to 21 C.F.R. 201.10(c), Review of Proprietary Names, in which PhRMA recommends that the regulation be repealed until such time that it can be shown to be effective in reducing medication errors.  This regulation allows the FDA to find a proprietary name misleading “because of similarity in spelling or pronunciation,” which may cause confusion “with the proprietary name or established name of a different drug or ingredient.”

Pharmaceutical companies vary widely in their process of developing trademarks. Some companies do quite a good job developing potential trademark candidates, using a brand name development company, pre-screening the names to assure legal availability, and then making judicious choices of potential names to send for safety testing with an outside safety expert such as Med-ERRS.

At the other end of the spectrum, some companies do not seem to review their names even in a cursory manner; we have been sent names to test that are only one or two letters different from currently-marketed products! If the FDA does not provide any level of testing, will companies perform trademark safety testing in the interest of medication error prevention?

While I believe that the pendulum has swung to an extreme end with the FDA proprietary name review process of late, with some questionable trademark rejections that in the past may have been approved, Med-ERRS does not agree that the entire process should be discarded. Based on what we have seen over the past 14 years related to medication errors between products with look-alike and sound-alike names, we believe that trademark safety testing does provide a level of “defense.”  

My hope is that the comments written by PhRMA will result in more dialogue among the key stakeholders, and that the ultimate goal, patient safety and medication error prevention, is at the forefront of that discussion.

Warm regards,

Susan


More on review of existing regulations
Federal Register Notice

Docket with comments


ISMP President blogs about PhRMA request to end trademark safety testing by FDA


Upcoming meetings that Med-ERRS will be attending

PTMG in Prauge, Czech Republic--October 12-15, 2011

ASHP in New Orleans, LA--December 4-8, 2011

Hope to see you there!

Update on PDUFA IV Pilot Project
Med-ERRS had the opportunity to work closely with a sponsor to develop a process for submitting a proprietary name for FDA review under the Pilot Project.  Unfortunately, since it was either the only submission or one of very few,    the FDA will not continue the Pilot Project after the original end date of September 30, 2011, due to lack of industry participation. 

It is our belief that due to this lack of submissions, a public meeting to discuss the findings of the Pilot will not be held.  We assume that a guidance will still be written, although it is unclear how closely it will mimic the Pilot Concept Paper. 

 

Hopefully, there will be an opportunity for additional dialogue among stakeholders prior to the final guidance being issued.


In the News

FDA applauds newly designed Merck product labels using standardized methodology
(click here for more on Med-ERRS package and label services)

Drug Shortages Result in Gray Market

Persistent Drug Name Pair Mix-up


 

Ask an Expert

If you have a question related to on e of Med-ERRS services or have an industry-specific inquiry, please Click Here and one of our experts will get back to you with an answer.

Med-ERRS Services

  • Trademark Evaluation : Med-ERRS has developed a service for evaluating the safety of trademarks called the ERRS MODEL ® , which incorporates various techniques recommended by the FDA to evaluate the safety of trademarks.
  • SCREEN-ERR : Helps companies evaluate multiple pharmaceutical trademark candidates at an early stage in the trademark development process.
  • Package and Label Evaluation : Helps clients create packaging and labels that are easy to understand and consistent with the most current FDA and world wide regulatory authorities.
  • Safety Consulting : Provides consultative services which are related to a variety of medication safety-related issues.


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