It’s been a rough couple of weeks for GlaxoSmithKline. On the eve of last week’s FDA hearings to decide whether its former best-selling diabetes drug Avandia should still be sold, the New York Times broke news of the company’s efforts to conceal internal studies showing the drug posed a much higher risk of heart attack than its main brand-name competitor, Actos. Yesterday, we learned that a member of the FDA panel received payments from GSK. And, today, the FDA put the brakes on a new trial to compare Avandia with Actos (hat tip: Pharmalot).
But buried in the onslaught of Avandia news (perhaps on purpose?) was the PR-challenged drugmaker’s announcement last Friday that “a small number” of Advair diskus inhalers, (used to treat patients with asthma and chronic obstructive pulmonary disease) stolen from a company warehouse had made their way into pharmacies. GSK’s announcement was followed by a stern FDA warning to consumers, pharmacists, and wholesalers to cease use of the stolen inhalers, which are identifiable by lot numbers.
This story is a troubling reminder that we do not have strong systems in place in this country to ensure our drugs have traveled legitimate and safe routes during distribution. As Adam Fein points out in yesterday’s Drug Channel blog, these stolen products ended up on pharmacy shelves due to negligent purchasing. Someone involved in the distribution of these inhalers purchased diverted products from a bad actor, either knowingly or by not adequately verifying product provenance.
We need strong federal regulation requiring manufacturers, wholesalers and pharmacies to track drugs during distribution and verify products’ distribution histories, also known as “drug pedigrees.” A robust federal tracking regulation with strong drug pedigree standards would help protect consumers from unsafe products. A number of state pedigree laws exist but vary in strength. Two bills have been introduced in the House that would establish federal drug tracking systems:
H.R.2726: Counterfeit Drug Enforcement Act of 2009 (Tim Fagan Law) Sponsors: Rep. Israel, Rep. Ackerman
H.R. 5839: The Safeguarding America’s Pharmaceuticals Act of 2008 (expected to be reintroduced this session) Sponsors: Rep. Buyer, Rep. Matheson
We hope this latest disturbing incident serves as another stark reminder of the urgent need for Congress and the FDA to take action to address the safety gaps in the drug distribution system. As for GSK and other manufacturers—they need to beef up their security, let the public and FDA know immediately when it is breached, and embrace proposed new tracking systems.
For more on drug safety and the importance of developing a prescription drug tracking system, visit the Pew Prescription Project’s Securing a Safe Drug Supply.
-- Kathy Melley, Director of Communications