Debate heats up over U.S. prescription drug tracking

WASHINGTON, April 25 Thu Apr 25, 2013 6:49pm EDT

WASHINGTON, April 25 (Reuters) - U.S. lawmakers seeking to create a national set of standards for tracking prescription drugs as they pass through the distribution chain heard testimony on Thursday from government and industry officials about how stringent the regulations should be.

The House and Senate each released draft bills this week designed to ensure that medicines can be tracked as they pass from manufacturer to distributor to pharmacy, to help prevent counterfeit or contaminated drugs from reaching the public.

The House draft, which was the topic of Thursday's hearing, requires drugs to be traced, but only in lots, which can contain thousands of individual bottles. The Senate bill would require each individual drug unit to be traceable, requiring a more significant investment in technology.

Previous attempts to create national standards have foundered amid complaints from companies that they would be too costly to implement. But some states have developed strong rules of their own, especially California, whose regulations are set to go into effect in 2015.

California requires that the distribution history and location of every drug, down to the smallest individual saleable unit, be accessible by regulators electronically, in real time. This would allow for the rapid isolation and recall of suspicious products.

It is the kind of system favored by the U.S. Food and Drug Administration, and shares certain similarities with the Senate bill, but some drug companies and distributors are fearful it will be too stringent.

"At present, the technology to support such a system is unreliable and underdeveloped, and the costs associated with such a model would be billions," Christine Simmon, senior vice president of policy and strategic alliances at the Generic Pharmaceutical Association, testified before a House Energy and Commerce subcommittee on Thursday.

The dangers of counterfeit drugs have been growing more apparent over the past decade. Just last year, fake vials of Roche Holding AG's cancer drug Avastin appeared in the United States from Britain where it was purchased from a Turkish wholesaler.

The World Health Organization estimates that less than 1 percent of medicines available in the developed world are likely to be counterfeit. Globally, that number is around 10 percent.

In the United States, 29 states have some type of regulation designed to track a drug's pedigree, but the rules are inconsistent.

"This patchwork not only creates operational challenges, but also leaves openings for bad actors to shop around for more lenient state rules," Elizabeth Gallenagh, vice president of government affairs at the Healthcare Distribution Management Association, which represents distributors, testified.

In Gallenagh's opinion, once a product is serialized, the requirements to trace it should not initially extend beyond the lot level, "with the potential for traceability at more discrete levels as systems mature."

Critics of the House bill argue such an approach would be inadequate.

"A system that tracks drugs by the lot number instead of at the unit level may provide incremental benefit over the status quo, but would fail to catch unsafe drugs in many scenarios," Allan Coukell, director of drugs and medical devices at The Pew Charitable Trusts, testified.

Dr. Janet Woodcock, director of the FDA's center for drug evaluation and research, told the subcommittee that a robust set of national standards is vital for combating counterfeit drugs.

"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," Woodcock said, adding that the agency will need "enforcement authority to ensure that parties adhere to implementation requirements."

While a 2007 law gave the FDA authority to set standards for authenticating and tracking prescription drugs, it did not provide the agency with explicit authority to require an effective track-and-trace systems for all drugs throughout the supply chain, she said.

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