Regulatory Focus™ > News Articles > Woodcock: FDA Strongly Supports Pharmaceutical Track and Trace

Woodcock: FDA Strongly Supports Pharmaceutical Track and Trace

Posted 26 April 2013 | By Alexander Gaffney, RAC

US regulators strongly support plans to introduce a pharmaceutical track and trace plan, the US Food and Drug Administration's (FDA) top drug regulatory official told legislators in testimony on Thursday.

Speaking before the House Energy and Commerce Committee's Subcommittee on Health on 25 April 2013, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), sought to answer legislators' questions regarding a long-standing question: What should the US do to better protect the pharmaceutical supply chain?

Supply Chain Defense

It's been a particularly pertinent question in recent years, as counterfeit versions of several prominent drugs-among them Avastin, a drug used in the treatment of several cancers, Adderall (amphetamine aspartate, a drug used to treat attention deficit disorder), and the painkiller Vicodin-have infiltrated the supply chain.

And those counterfeits have the very real potential to harm patients, Woodcock noted. "A counterfeit drug could contain a substance that is toxic to patients.  But even a counterfeit drug with no active ingredient could prove harmful to patients who take it, thinking that they are taking a lifesaving or life-sustaining medication, when they are not."

Stolen goods, too, present a risk to consumers, as it is impossible to determine whether the drugs are the same substance once manufactured in good conditions, or whether they have been appropriately stored throughout the supply chain. Woodcock cited a 2009 example in which 129,000 vials of Levemir, an insulin product, were stolen and stored improperly before making their way back into the supply chain.

Benefits of Track and Trace

These examples serve to illustrate a larger purpose, Woodcock said.

"While we recognize that we may not be able to eliminate all problem products from the supply chain, we take every step we can to make the supply chain more secure to keep the illegitimate products out," she stated.

Every step, that is, save one: Implementing a pharmaceutical track and trace system, authority for which the agency does not currently have - much to the detriment of consumers, Woodcock added.

"Implementation of a system to fully track and trace prescription drugs throughout the supply chain would help in combating incidents like these counterfeit examples."

Track and trace is essentially a collection of tools employed to make sure regulators and companies can determine the authenticity, identity and whereabouts of a particular drug product. It is so named because, under an ideal system, regulators would be able to track where a product is going in the supply chain and trace where it has been.

Moving Forward

The good news, from FDA perspective, is that Congress is now considering two separate proposals, introduced in both the Senate and House of Representatives, that would serve to implement a lot-level (rather than unit-level) track and trace system in the US. Woodcock noted that she has worked-and continued to work-with legislators to "provide technical assistance in response to legislative proposals to secure the downstream pharmaceutical supply chain."

Woodcock also laid out FDA's position on track and trace, saying the agency would like to see four distinct requirements in the final legislation:

  • clear details regarding implementation timelines
  • enforcement authority-teeth, if you will-to ensure that requirements are adhered to
  • distribution history maintenance requirements for all market participants in the supply chain
  • reasonable time frames for implementation "based on what is technologically possible"

"An effective national track-and-trace system for all drug products throughout the supply chain would improve the security and integrity of the drug supply and ensure transparency and accountability of product distribution," Woodcock concluded. "Many of the challenges we have with securing the supply chain-including contamination, diversion, counterfeiting, and other adulteration-could be addressed by such a system."

Rep. Fred Upton, chairman of the Energy and Commerce Committee, agreed with those sentiments at the Thursday hearing, adding that he plans to do everything he can to get the legislation signed into law by the August 2013 congressional recess, The Hill reports.

Janet Woodcock's Testimony

Regulatory Focus newsletters

All the biggest regulatory news and happenings.