Keynote Speaker Announced for Counterfeit Drug Conference

The Partnership for Safe Medicines is pleased to announce Deputy Director Ilisa Bernstein as the keynote speaker of the 2013 Interchange on October 24, in Washington, DC.

Dr. Ilisa Bernstein is the Deputy Director of Office of Compliance in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). She works towards promoting and protecting public health through strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs. She assists in the management of strategies, activities and policies for drug compliance and enforcement. Prior to her placement at CDER, she spent four years as the Director of Pharmacy Affairs at the FDA, where she focused on drug integrity, supply chain security, counterfeit drugs, drug importation, prescription and OTC drug labeling, and internet issues, among others.

In the past two years there have been a number of broad supply chain breaks that have impacted patients, including infiltration of the legitimate supply chain with counterfeits, medicine diversion and pedigree falsification, and the distribution of unsafe drugs through illegitimate suppliers.

  • Counterfeit cancer drugs have been discovered 3 times in the U.S. drug supply: February 14 and April 3 in 2012, and on February 5, 2013.
  • Counterfeit Adderall found: On May 29, 2012, FDA sent out a consumer and healthcare professional warning concerning the discovery of counterfeit Adderall available for sale on the Internet.
  • Counterfeit Botox warnings: On December 19, 2012, doctors in 39 states, including a Dallas area hospital, received warning letters from the FDA that cautioned them about their dealings with drug sellers identified as suppliers of counterfeit Botox.

Other speakers at the Interchange include:

Christopher Weaver, Medicine and Science Writer for the Wall Street Journal. Mr. Weaver has broken several stories concerning the discovery of counterfeit cancer medications in the U.S. supply chain.

Special Agent Daniel Burke, Senior Operations Manager in Charge of Cyber-Crime Investigations for the FDA’s Office of Criminal Investigations will talk about the risks to consumers from using fake online pharmacies.

Roger Gural of the U.S. Department of Justice Consumer Protection Branch will tell us about counterfeit cases he has resolved, and what consumers have been exposed to by the actions of drug counterfeiters.

Register for the 2013 Interchange
to hear these speakers and other policymakers, patient advocates, law enforcement and healthcare advocates as they discuss the dangers of counterfeit medications, and possible solutions to protect American patients.

By S. Imber