Having passed food safety, 111th Congress should turn to drug safety
Among the food that has been recalled for contamination risks since the 111th Congress convened:
-Eggs (500,000,000+) -spinach -peanuts/peanut butter -pistachios -tomatoes -jalapenos -70,000 lbs of cheese
Among contaminated or recalled drugs suspected of safety problems since the 111th convened:
-Heparin -millions of Tylenol, Motrin, Benadryl bottles, child and adult formulations -Lipitor -Paxil -Bactroban -Tagamet -Kytril -IV antibiotics
This week, the Senate finally passed a food safety bill (the House passed a version this summer). The bill, if signed, will give FDA resources to inspect manufacturing plants and farms and give the agency authority to recall food it considers unsafe (right now, a company must initiate a recall voluntarily.) With a little red tape between here and the President’s desk, the bill is on the verge of making much-needed and overdue reform to the way we protect and oversee our increasingly globalized food sources.
Our drug supply faces the same need. Our drugs are increasingly made from materials from all over the world, and GAO reports suggest thousands of plants that potentially manufacture raw materials for prescription and over-the-counter drugs on American pharmacy shelves go uninspected each year. Right now, manufacturers aren’t held accountable enough for ensuring all those materials are safe.
This year saw a record number of drug recalls for Good Manufacturing Practice (GMP) violations, signaling the FDA is marshaling its resources well to step up vigilance. But it also suggests that there are big and perhaps growing quality problems plaguing the supply chain that manufacturers don’t have a handle on yet. Bills and a discussion draft before Congress now would give the FDA mandatory recall authority, as the agency will have now for food, and would establish more stringent supply chain management requirements for drug makers that regulators could use to better enforce drug quality and safety, both in the drug application and post-market phase.
The tools are there, and so is the urgency. We hope before this Congress adjourns that it moves to protect the drugs in American medicine cabinets the way it acted this week to protect the food on our tables.
For more on how to secure America’s drug supply, follow SafeRxWatch on twitter and Facebook, and visit Community Catalyst’s Prescription Access and Quality resources and the Pew Prescription Project.
–Kate Petersen, PostScript blogger