FDA's Sharfstein talks REMS, track and trace

Be on the lookout for FDA guidance on unique identification for prescription drug packages, says FDA principal deputy commissioner Joshua M. Sharfstein, speaking to the U.S. House of Representatives last week. The unique IDs will help in identifying "the whereabouts and authenticity of drug packages and distinguish them from counterfeits."

Sharfstein notes that the FDA Amendments Act requires development of standards for the identification, validation, authentication, and tracking and tracing of prescription drugs and the ingredients that go into them. In attendance was Commerce Committee chairman Henry Waxman, who says drugmakers need to step up their efforts at drug safety. "We need to place a greater onus on all manufacturers to oversee the safety of their own products," according to a press report.

Sharfstein acknowledges pharmas' efforts, citing some as "terrific," while agreeing that still more needs to be done. "We are working with industry to help them strengthen the safety of their supply chains," he says in his prepared comments.

He also describes the FDA's authority to require risk evaluation and mitigation strategies (REMS) for some drugs, with the goal of ensuring that the benefits outweigh the drug's risks. REMS design requires "a careful balancing" of risk management and patient access to medications. "Since using this authority is a work in progress, FDA is committed to addressing the concerns we have heard" from the factions affected, he says. He promises a public meeting. 

- read Sharfstein's remarks
- here's the Reuters report