"Do you have the authority and the resources you need to address the safety of components now being imported into this country, yes or no?"
"Do you have the necessary authorities and resources to see to it that drugs are only imported from facilities overseas that are properly observing good manufacturing practices--that is a word of art--..."
"Do you have the ability to see to it that raw-materials suppliers also engage in good manufacturing practices abroad?"
"Do you have the resources needed to conduct foreign drug-facility inspections with the same frequency as domestic drug-facility inspections?"
"How often can you get by to see a foreign drug manufacturer?"
"Do you need additional authorities to be effective in that?"
"I have great concern for the tremendous amount of pharmaceutical medicines and ingredients that are coming in from abroad."
"Is that sufficient or not?"
"Are today's GMPs sufficient to ensure manufacturing quality, yes or no?"
"One approach to ensuring manufacturing quality would be to require manufacturers to implement quality systems that detail management responsibilities, risk management practices, supply chain managemen..."
"More must also than done to ensure transparency and access to information for products being imported into the United States."
"Mr. Chairman, you are most courteous. I thank you for having this hearing, and I appreciate your concern for the questions before us."