Still think producing raw material overseas will reduce costs?
Earlier this week, FDA officials told Congress it needed $225 million in additional funding to inspect the 3300 foreign drug manufacturing facilities as frequently as it inspects facilities in the United States. This amount is nearly 20 times the agency’s existing budget for such inspections and about one-tenth its overall budget.
FDA said it needs the funding to expand its authority to inspect overseas manufacturers that ship products to the US, stop shipments at the border if the supplier has not been inspected, and require that US pharma companies adequately monitor their their suppliers.
Meanwhile, spokespersons from Baxter told the congressional committee that they believe someone intentionally contaminated the heparin batches that were recalled earlier this year. The spokesperson said the company is “alarmed” that their product “was used in what appears to have been a deliberate scheme adulterate a life-saving medication.” Scientific Protein Laboratories (SPL) has insisted that it was no one within their company. There was no ruling on whether the contamination was deliberate or accidental.
All this comes as no solace to Leroy Hubley of Toledo, Ohio, who was one of the first to testify at the hearing. Hubley lost his wife of 47 years last December and his son a few weeks afterward as a result of complications from contaminated heparin. Those deaths are among the reported 81 in the US possibly linked to the contamination (which brings up the question: if your family member died from a tainted product, would you agree to increase federal funding (tax dollars) to support and trust a system that you thought would detect and stop that contamination in the first place?)
Also of note: Baxter and SPL publicly apologized to families of those affected by the incident (interpret what you will from that, but there is still no such apology from Congress or FDA).
(source: Baltimore Sun, April 30)