More calls for shoring up safety gaps in the safety of the U.S. drug supply came from the Hill this week in the wake of a wide recall of children's medicines. Congresswoman Rosa DeLauro (D-CT), a frequent advocate for better drug and food safety, has joined those in Congress seeking answers to McNeil Healthcares’ latest batch of recalls.
The Congresswoman has asked about the FDA’s role in inspecting plants and whether it needs better recall authority after McNeil, a division of Johnson & Johnson, pulled 43 types of children’s Tylenol, Motrin, Zyrtec, and Benadryl from the shelves last week. The recall came after the company reported 46 consumer complaints between June 2009 and April 2010 about foreign materials and dark specks in the medicines, and an FDA inspection of the plant in Fort Washington, Pennsylvania turned up raw materials that were contaminated with gram-negative bacteria.
In a letter addressed to FDA Commissioner Dr. Margaret Hamburg, Rep. DeLauro expressed concern that the agency does not have adequate authority to recall drugs (it can only suggest, but not enforce, a recall).“What can be done to enhance the agency's ability to effectively monitor drug production and actual practices at domestic facilities?” she wrote to Dr. Hamburg.
DeLauro also inquired into the FDA’s system for ensuring that all consumers receive recall information, and its authority to address potentially criminal corporate actions.
Last week, the House Committee on Oversight and Government Reform began a bipartisan investigation into the origin of the J&J recall.
Concerns in Congress about the quality safeguards in the U.S. drug supply have been mounting, and the latest recalls point to how widespread the effect of a manufacturing problem in such a globalized supply chain can be: news reports suggest that the recall affected 70 percent of the U.S. market in over-the-counter liquid medications for children.
In March, a House hearing on drug safety highlighted gaps in the system for safeguarding the U.S. drug supply–gaps which may have exacerbated the heparin contamination in 2008, and recalls like Johnson & Johnson's.
This is the company’s fourth recall in seven months.
Visit the Pew Prescription Project for more on improving the safety of the U.S. drug supply.
--Kate Petersen, PostScript blogger
photo credit: Wikimedia Commons