Regulatory Focus™ > News Articles > Report: 'Track and Trace' Anti-Counterfeiting Provisions Likely Casualty of User Fee Markup

Report: 'Track and Trace' Anti-Counterfeiting Provisions Likely Casualty of User Fee Markup

Posted 25 April 2012 | By

A long-awaited and much-called-for plan to introduce a 'track and trace' plan to cut down on pharmaceutical counterfeiting may be cast by the wayside in the legislative markup process for new legislation, reports Reuters' AlertNet.

Track and trace programs, used by regulatory authorities to keep track of authentic drugs and trace their transmission through the supply chain, have been receiving increased attention in recent years.

The US Food and Drug Administration (FDA) has been a huge proponent of track and trace elements, holding a workshop on the subject in 2011, and speaking out in favor of it on numerous occasions.

Speaking on 10 April, FDA Commissioner Margaret Hamburg lent her support to the measure, saying "a robust system to track and trace all drugs throughout the supply chain" would greatly assist the agency in its mission to protect the public.

FDA's top pharmaceutical regulator has also endorsed the measure.

"Currently there is no complete record of all parties who have been involved with the distribution of a product after it leaves the manufacturer until it reaches the hands of the patient," said FDA's Director for the Center for Drug Evaluation and Research (CDER), Janet Woodcock on 2 March 2012. "This leaves multiple opportunities for counterfeit, adulterated, stolen or otherwise violative products to be introduced into the supply chain."

Speaking on 29 March, FDA's Associate Commissioner for Regulatory Affairs, Dara Corrigan, testified before a House Subcommittee on the topic of drug counterfeiting, and also lent her support to track and trace provisions.

"FDA has responded to this emerging threat by strengthening its ability to prevent the introduction of counterfeit drugs into the U.S. distribution chain by facilitating the identification of counterfeit drugs working with US medical product supply chain stakeholders to develop guidelines related to the integrity of our country's closed distribution system, such as the tracking and tracing of prescription drugs, in order to keep counterfeits out of this system," said Corrigan.

The measure, then, is not failing for a lack of support. Neither is it failing for a lack of high-profile supply chain breaches. Counterfeit copies of Roche AG's drug Avastin (bevacizumab) has been found in the US supply chain twice during the first four months of 2012-once in February and once in April-drawing addition scrutiny to the problem.

Instead, the resistance to the proposed track and trace plan "comes from a range of players, from huge drugmakers like Pfizer Inc and Merck & Co Inc to distributors and corner pharmacies," writes Reuters.

The manufacturers argue-as they have for some time-that the program is a costly burden that requires an up-front investment in infrastructure and continued maintenance costs, reports Retuers. The costs, estimated to cost billions of dollars, should not be borne by them, they argue.

Instead, the drugmakers are arguing on behalf of a different plan that would substitute the tablet-level track and trace program for a lot-level program, which could later be scaled up if needed.

"Often in crafting policy, there's the search for the perfect and we just walk by the good," said Pfizer spokesman Peter O'Toole on the plan, who added expediency and ease-of-use was the goal of the counter-proposal.

That proposal was introduced during the Senate markup process by Sens. Bennet and Burr, reports The Pink Sheet Daily, but faced "FDA opposition" and failed to pass the Senate's amendment process for inclusion into the bill, reports SCRIP Intelligence.

The Senate's Health, Education, Labor and Pensions (HELP) Committee held a hearing 25 April to markup the legislation, and ultimately passed the amalgamation of user fee legislation known as The Food and Drug Administration Safety and Innovation Act.

The next markup for use fee legislation-and likely the last chance for track and trace provisions to be included at all-comes 8 May when the House Energy and Commerce Subcommittee on Health meets for their own markup process.

Read more:

Reuters - US may lose chance to pass national drug trace plan

Regulatory Focus - Woodcock Calls for Prescription Drug Tracking System

Regulatory Focus - Corrigan: FDA Transforming to a Global Agency, Success Depends on Partnerships

Regulatory Focus - Hamburg Calls for New Authority, Strengthened Anti-Counterfeit Laws

Regulatory Focus - New Batch of Counterfeit Cancer Drug Avastin Found in US

Regulatory Focus - Spotlight on Counterfeiting After Fake Avastin Found in US

Regulatory Focus - Hamburg: FDA Needs More Anti-counterfeit Authority, International Track and Trace Cooperation

Regulatory Focus - Journal: Counterfeit Market Doubling, Risking Supply Chains

The Pink Sheet Daily - Track and Trace Battle Looms At Senate User Fee Mark-Up

Regulatory Focus - Drafts of PDUFA, MDUFA Released in House, Senate

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