Choosing the Right Drug Name: How to Increase Your Chances for Approval

Held July 23, 2008

Creating the name of a new drug in a market that already houses more than 22,000 drugs is no easy process. Nor is it cheap!

At a minimum, manufacturers must make certain their proposed drug name passes the worldwide trademark requirements, complies with standards not to imply a medical claim and meets standards for patient safety.

If the FDA rejects a name that a drug company has spent years and possibly millions of dollars creating, it can cost millions more in both lost sales and trashed marketing and sales materials … and then it’s back to the drawing board!

Now, the FDA has introduced a proposal to redevelop the drug-naming process. It held a meeting on June 56 with industry leaders to gather feedback on new plans, which resulted in very little positive feedback.

In fact, Carol Holquist, the director of the FDA’s Division of Medication Error Prevention and Technical Support, said that even if a firm follows the FDA’s proposed ideas to the hilt, it still wouldn’t guarantee approval.

Drug safety expert Susan Proulx will detail the industry’s concerns that were a result of the FDA’s June 56 meeting, and provide thoughts on how the proposal might change. She’ll also provide five best practices for what companies can do now to win FDA approval. In addition, Susan will outline the top seven reasons drug names get rejected.

Order today to listen in and discover:

  • Details of the industry’s concerns as expressed in the June meeting
  • Analysis of the review factors involved in the causes of medication errors related to trademarks
  • Five best practices for what companies can do now to win FDA approval
  • The role of the FDA’s Division of Medication Error Prevention (DMEDP) in evaluation of trademarks from the safety standpoint
  • The current process that DMEDP uses to evaluate trademarks
  • The role of DDMAC in the evaluation of trademarks from a promotional standpoint
  • The top seven reasons drug names get rejected
  • Current standing of the PDUFA IV legislation as it relates to proprietary name evaluation by pharmaceutical companies

Find out what industry concerns were exposed during last month’s meeting with the FDA — and what’s likely to happen as a result. PLUS, discover what you can do now to get your drug’s name approved by the FDA.

This audio CD/Transcript is a must for positions in drug and biologic companies, including:
  • Sales and marketing personnel
  • Compliance officers
  • Regulatory and legislative affairs professionals
  • R&D staff
  • Executive management
  • General and corporate counsel
  • Risk management specialists
  • Strategic planning and business development staff
  • Consultants and service providers
  • Personnel new to the industry

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Susan Proulx, PharmD, has been president of Med-E.R.R.S (Medical Error Recognition and Revision Strategies) since March 2000. She earned her B.S. in Pharmacy and Pharm.D. degree from Northeastern University in Boston, MA and completed an ASHP Residency at the Veterans Administration Medical Center in Philadelphia, PA.

Susan’s previous professional experience includes both community and hospital pharmacy practice with eight years affiliation with the Medical College of Pennsylvania and its hospital in clinical and program director positions. Prior to joining ISMP in 1995 as vice president, operations, Susan was a pharmaceutical consultant, as well as director of business development for ADIS International. She is a preceptor for students from the University of the Sciences in Philadelphia and Temple University, School of Pharmacy.

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