* Could catch fake drugs entering legal supply chain
* FDA, industry cannot agree on details
* Time running out to pass national law
By Anna Yukhananov
WASHINGTON, April 25 A proposed law calling for
healthcare companies to build a U.S. system for tracking
medications to minimize the threat of fake drugs is in jeopardy,
thanks to arguments over cost and a looming deadline.
The U.S. Food and Drug Administration said earlier this year
that counterfeit vials of cancer drug Avastin were sold to
dozens of medical practices across the country, sparking new
fears about the safety of the drug supply.
The agency has been working on a "track and trace" system
for nearly a decade, and has until September to introduce it as
part of its funding laws, or wait another five years for the
opportunity under Congressional rules. Europe beginning in 2016
will require a unique identifier on all medicine packages.
"To learn that the cancer drug you were taking to save or
prolong your life might be nothing but a counterfeit is
unthinkable," FDA Commissioner Margaret Hamburg wrote on the
agency's blog earlier this month. "We ... need authority to
require a robust system to track and trace all drugs throughout
the supply chain."
But resistance to the proposed plan comes from a range of
players, from huge drugmakers like Pfizer Inc and Merck
& Co Inc to distributors and corner pharmacies.
The main complaint is money and who pays for individual
vials of medicine to carry their own serial numbers and a
unified technology infrastructure to keep track of them.
Pharmacy officials estimate that it would take more than $6
billion just for pharmacies to make that happen, on top of
whatever drugmakers and distributors might have to pay.
A coalition of drugmakers, distributors and pharmacies is
pushing an alternative plan it says is cheaper and easier, but
would focus on tracking much larger "lots" of drugs rather than
the individual packages. They say their plan would pave the way
for more stringent rules later.
"Often in crafting policy, there's the search for the
perfect and we just walk by the good," said Peter O'Toole, a
spokesman for Pfizer, a member of the coalition.
"We could be saying in 10 years, 'we have to work on
something perfect.' And in the intervening years, we would have
done nothing, and that would be a shame for patients."
Both sides of Congress are editing their draft versions of
the FDA "user fee" funding bill this week, after which it will
be more difficult to include new provisions.
The industry's plan may make it into the Senate version of
FDA "user fee" funding bill, after Richard Burr, a Republican
from North Carolina, and Michael Bennet, a Democrat from
Colorado, on Tuesday proposed an amendment along those lines.
But the House of Representatives, which is planning to
submit its user fee bill for President Barack Obama's signature
by the end of June, has not agreed on a version yet.
A TEST CASE IN CALIFORNIA
The fight over how to track medications sold in the United
States has already been staged in at least one state. California
legislators passed their own law for a track and trace system in
2004; healthcare companies were able to delay its implementation
three times, and it is now scheduled to begin in 2015.
Now that the law is finally coming into effect, it has at
least brought the industry to the table. Their concern is that
other states will follow suit, leading to a complicated
patchwork of laws rather than a coordinated federal plan.
A national law to prevent Americans from getting
counterfeit, expired, or adulterated drugs has been on the books
since 1987. All medicine sold in the country already must be
marked with an ID number that shows its dose and name.
But this number is the same across thousands of drugs, and
says nothing about who sold the drug to whom, where it went, and
how long it took to get there.
A unit-level tracking system would not stop doctors or
patients who wanted to buy outside the legal supply chain, from
unlicensed distributors or online pharmacies.
But it would send a red flag if a licensed distributor tried
to scan a drug from an unknown source, said Ilisa Bernstein,
acting director of the FDA's Office of Compliance.
"Each package would have its own identity, and you'd be able
to verify each package to see if it's fake," she said.
California's regulators ran into the limits of the current
system in 2008, during a national scare over tainted versions of
the blood thinner heparin. In a few cases, medicine that was
recalled from state hospitals still reached patients.
Virginia Herold, executive officer of the California Board
of Pharmacy, said in three cases a hospital received heparin
from its wholesaler, sent it back, and then received the
recalled heparin again several months later because the
wholesaler did not recognize that the product was recalled.
"The U.S. still has the safest drug supply in the world. But
it's under assault," she said.
Industry officials back a plan to put unique serial numbers
on individual drug packages, but require scanning drugs in
"lots" only when they reach distributors, lumping together a
hundred or thousand drug packages each, depending on the
Lot numbers already appear on drug packages, so the entire
system could be in place by 2020, said Liz Gallenagh, in charge
of government affairs at the Healthcare Distribution Management
Association (HDMA), a trade group representing distributors like
AmerisourceBergen Corp and Cardinal Health Inc.
"It's going to start with lot-level traceability, basically
thinking you can't run before you can walk," she said.
Pharmacy groups also say implementing a national system to
trace drugs could hurt small businesses. They cite estimates
that individual pharmacies would each have to pay $84,000 to
$110,000 to implement the system in its first year.
"That's pocket change for the big guys, but for our guys it's
a completely different story," said Susan Pilch, senior director
for policy and regulatory affairs at the National Community
Critics fear the industry plan is meant to pre-empt the more
stringent California law, and companies would never agree to
anything more comprehensive down the line.
"Distributors and pharmacists telling us they don't need
item-level serialization is like drunk drivers telling us they
don't need breathalyzers," said Walter Berghahn, who has worked
on track and trace issues since 2004 and is the president of
SmartRmeds For Life, which focuses on medication adherence.
Either way, lawmakers who have backed a national system
appear unwilling to propose their own bills, separate from the
FDA's user fee legislation, to get the job done.
It is still unclear which version, if any, will make it into
the final user fee draft, as congressional aides have said they
want broad-based agreement between the FDA and industry.
"We're reviewing the proposal and look forward to working
with Congress on a track and trace system that will protect
patients from counterfeits," FDA spokeswoman Karen Riley said.