Congress poised to pass safety-focused FDA bill

WASHINGTON (AP) — A bill designed to beef up the safety of the nation’s prescription drug supply is poised to pass Congress, but without a tracking system that public health advocates say is critical to weeding out counterfeit pharmaceuticals.

House and Senate lawmakers agreed late Monday on compromise legislation that helps supplement the Food and Drug Administration’s budget. The two chambers previously passed separate versions of the bill, which also increases safety inspections and penalties against drug counterfeiters.

Lawmakers dropped a Senate provision which would have created a national network for tracking drug shipments and preventing counterfeit and stolen drugs from entering the U.S. supply chain. Pharmaceutical companies and regulators have argued over the cost and scope of the network for over a decade, though industry observers hoped this year’s must-pass FDA bill might provide a vehicle for a compromise.

Key lawmakers said Tuesday they were unable to bridge disagreements over the so-called track-and-trace system.

“During the conference process we came very close to consensus and it’s unfortunate that the process is moving forward without track-and-trace at this point,” said Sen. Michael Bennet, D-Colo.

The FDA and safety advocates have pushed for a system that would track each individual drug bottle through the supply chain using electronic barcodes or tags. Such systems are already used in countries like Belgium, Sweden and Turkey.

But industry groups said tracking every individual unit could be too expensive and burdensome for manufacturers, suppliers and health care professionals. Medicines typically pass from manufacturers to distributors to hospitals and pharmacies before reaching patients. Instead, drugmakers proposed a system that would track medicines at the lot level. But safety advocates said that approach wouldn’t be very useful, since each lot can contain tens of thousands of bottles.

“If we’re going to invest in a national system it has to address the weaknesses we face,” said Allan Coukell, director of medical programs for Pew Charitable Trusts, which lobbied on the bill. “We need to have a way so that when counterfeit or stolen drugs enter the system they can be identified.”

Last week congressional staffers reported progress on a compromise which would have created a system based on industry’s proposal, but then gradually transitioned to the bottle-level tracking favored by the FDA. Staffers said this week the two sides couldn’t agree on details for the transition.

Pharmaceutical companies have recently gotten more aggressive in pushing for a national framework to avoid the costs of complying with individual state tracking laws, including one in California set to take effect in 2015. The law — which has been delayed three times since 2004 — requires drugmakers to assign serialized codes to all prescription drugs sold in the state by 2015. Distributors would have to begin tracing the codes by 2016.

Industry groups said Tuesday they would continue working toward a federal track-and-trace system. But Congress is unlikely to pass another major health care bill this year, offering few vehicles for any new proposal.

The risks of counterfeit drugs entering the U.S. hit home earlier this year when FDA reported two separate batches of a fake cancer drug, Avastin, were distributed to doctors in several states. A government investigation is ongoing.

The House is expected to vote on the compromise FDA legislation Wednesday afternoon. Lawmakers there previously passed the bill by an overwhelming 387-5 vote. A vote in the Senate is expected early next week.

The legislation’s underlying purpose is to renew, through 2017, a program under which drugmakers pay the FDA set fees for the agency to review new medications. Under the latest version of the bill, the FDA would collect $6.4 billion in fees from companies over the next five years, starting in 2013.

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