U.S. Lawmakers Advance Bill on Prescription Drug Tracking

09.05.2013 -

A U.S. House of Representatives panel advanced a bill on Wednesday on how the federal government should track prescription drugs as they move through the distribution chain, over the objections of some Democrats who said the proposal did not go far enough to ensure safety.

The draft legislation approved by the House Energy and Commerce health subcommittee was aimed at enhancing supply chain security for patients, including protection against counterfeit or stolen drugs.

The bill will "ensure that overlapping red tape does not impose dramatic costs on patients in the form of higher prescription drug costs or potential drug shortages," said subcommittee chairman Joe Pitts, Republican of Pennsylvania.

The House bill would require drugs to be traced only down to the level of lots, which can contain thousands of individual bottles, or packs of vials.

A Senate version introduced in April would require each individual drug unit to be traceable, after a phase-in period.

The House bill would establish a timeline that could delay even the consideration of tracking drugs down to the unit level by more than a decade.

The U.S. Food and Drug Administration would be asked to propose such regulations in 2027, 12 years after the potential implementation of the current bill. Those FDA rules could not be in place until 2029 at the earliest, and might never go ahead, according to critics.

"This prolonged timeline will eradicate momentum in the supply chain towards unit-level traceability," the Pew Charitable Trusts, which supports tougher regulations, said in a letter to subcommittee leaders.

Many Republicans oppose tracing drugs down to individual units as too costly to pharmaceutical companies.

At a hearing in April, a representative of the Generic Pharmaceutical Association said the cost of tracking drugs down to the unit level would be in the billions of dollars.

Also advancing on Wednesday was HR 1407, a separate bill to reauthorize user fees for veterinary drugs. The FDA collects funds under the program to help speed up approval of new drugs for pets and livestock.

It is unclear when the bills will be moved to a vote by the full committee.

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

California will require the distribution history and location of every drug, down to the smallest individual saleable unit, be accessible by regulators electronically, in real time.

The dangers of counterfeit drugs have been growing more apparent over the past decade. In 2012 fake vials of Roche's cancer drug Avastin appeared in the United States from Britain, where they were purchased from a Turkish wholesaler.

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