Can current safeguards in our medicine supply prevent another heparin crisis, and how do we confront quality problems so extensive that the government must seize factories because of the risk to public health? On Monday and Tuesday Mar. 14-15, the Pew Health Group will bring together members of industry, policymakers, regulators and consumers to tackle these and other key questions about overseas drug manufacture, distribution and safety.
“After Heparin” comes at a critical moment. Since adulterated batches of the blood-thinner heparin from China were linked to more than 100 American deaths in 2007 and 2008, a spike in drug recalls and manufacturing violations signal breakdowns in internal quality and oversight systems. Just yesterday, the FDA took over three Johnson & Johnson plants after endemic quality problems that led to near-weekly recalls went unfixed.
The FDA and Justice Department’s seizure, known as a consent decree, “is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity,” Director of FDA’s Office of Compliance Deborah Autor told CNN. Autor will speak Monday at the “After Heparin” conference.
And on this Sunday’s 60 Minutes (7 ET on CBS Mar. 13), Dr. Sanjay Gupta will look at the problem and proliferation of counterfeit medicines, and how they can make their way back into the legitimate U.S. drug supply. (Here’s a preview). Experts believe the cost-incentive of using adulterated materials was a driving factor in the tainted heparin from China.
As the number of raw materials and ingredient suppliers in low-cost economies mushrooms, knowing where our drugs come from has gotten harder to determine. Eighty percent of all ingredients in medicines brought into the U.S. are now made overseas, and though FDA foreign inspections have increased, an inspectorate designed for a much smaller domestic market has not been able to keep pace. Congress has proposed legislative solutions to address these safety gaps, and Americans—nine of ten—overwhelmingly support such fixes.
FDA acting Deputy Commissioner John Taylor and U.S. Senator Michael Bennet from Colorado will deliver keynote addresses at “After Heparin,” and roundtables made up of major industry associations, consumer groups – including Community Catalyst – regulators and scientists will look at the major questions and potential policy solutions around quality systems, inspections, and counterfeit detection and deterrence.
For a conference agenda and more information, visit the Pew conference page.
Check back at PostScript Monday and Tuesday for conference exclusives, watch the live webcast here starting Monday at 8:30 am Eastern, and follow SafeRxWatch on Twitter for live updates from the conference.
–Kate Petersen, PostScript blogger