The US Food and Drug Administration was buffeted by questions and criticism last year after the emergence of contaminated heparin. Lawmakers questioned whether the agency had investigated the problem thoroughly and been forthcoming about its findings. Several of FDA’s recent measures provide reassurance that it is attempting to protect American patients from contaminated drugs produced abroad.
Last Thursday, the agency opened offices in New Delhi and Mumbai, India. The offices are staffed with technical experts who will work with Indian government and industry officials to develop certification programs for medical products exported to the US. The staff also includes inspectors who will check facilities that manufacture products for the US market. Last fall, FDA opened similar offices in three locations in China.
And last Wednesday, the agency launched a pilot program to determine the feasibility of setting up a supply-chain monitoring network. FDA is asking qualified drugmakers to volunteer supply-chain information for drugs and APIs sourced outside the US. Companies will need to demonstrate control of drugs from the time of manufacture to the time they enter the US.
I think these measures are sorely needed. I’m happy to see FDA take meaningful steps toward securing the supply chain. Offices in major drug-producing countries will help the agency promote good manufacturing practices and perform inspections. The pilot program could lay the basis for a valuable infrastructure to ensure the safety of drug imports. I applaud the agency’s initiative. Here’s to its success.