Point of View

Burr's bill would put much-needed track and trace on our medicine

May 17, 2013 

American consumers and businesses in every state are affected by the increasingly lucrative and dangerous business of counterfeits. In March, authorities seized nearly $4 million in counterfeit products – from fake Viagra to knock-offs of Prada bags and TaylorMade golf clubs – in neighboring South Carolina.

The raid was the result of a joint effort by U.S. Immigration and Customs Enforcement, Homeland Security Investigations, the state of South Carolina, Blazer Investigations and Pfizer. In making the announcement of the seizure, the state’s Secretary of State said it best: “Fake medicine takes this harm to another level because it can literally kill you.”

While counterfeit drugs may contain some of the main ingredients in the branded medicine, they are also known to contain harmful ingredients such as chalk, brick dust, paint and even pesticides. The World Health Organization estimates that more than 50 percent of medicines purchased over the Internet from illegal sites that conceal their physical addresses are counterfeits.

Just a few weeks ago, a man in Montana pleaded guilty to a federal charge of covering up a felony in relation to shipping illegal fake medicines by Canada Drugs. This Internet pharmacy and drug wholesaler became notorious for its involvement last year in the distribution to U.S. doctors of a counterfeit version of a well-known cancer drug.

The issue of counterfeit drugs is currently a topic of serious and thoughtful discussion on Capitol Hill. The House Energy and Commerce Subcommittee on Health recently held a hearing on the matter, and both the House and Senate are marking up draft bills aimed at securing the pharmaceutical distribution supply chain. The Senate bill is co-sponsored by N.C. Sen. Richard Burr.

As the hard work of consolidating the bills into one piece of legislation for final passage is underway, we should be encouraged by the broad bipartisan support for a national track-and-trace system to protect American patients. Track-and-trace lets authorities follow a drug from the first commercial sale by the manufacturer to the point of dispense.

Currently, more than 30 states have disparate laws to track drugs along the supply chain. As a result, states with more relaxed laws inevitably attract bad actors who seek to introduce illegitimate products into the distribution chain. In addition, the burden on businesses of unclear or inconsistent state laws is extreme. Each manufacturer, wholesale distributor, third-party logistics provider and dispenser has to figure out how the patchwork of regulations across the country applies. A national system is desperately needed.

The United States has one of the safest pharmaceutical supply chains in the world, but the gaps are an increasing threat to public health. As recently as August 2012, the U.S. Food and Drug Administration had issued four separate letters warning health care professionals about several counterfeit cancer drugs.

To prevent fake medicines from reaching patients, Congress must pass a uniform, national traceability law. A national track-and-trace system would require that prescription drug products contain sophisticated technology able to determine the product’s source and distribution history and provide immediate protection. It also would give the FDA the nationwide authority to keep the system safe from bad actors and ensure an efficient and cost-effective system applicable in all 50 states.

During a recent House hearing, Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, testified that the counterfeiting problem is getting worse.

Congressional action is needed now. Otherwise, nobody can fully guarantee that the current system adequately protects patients. That is a hard pill to swallow.

Tony Maddaluna is executive vice president and president of Global Supply at Pfizer.

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