| WASHINGTON, April 25
WASHINGTON, April 25 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
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
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
"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
"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
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.