Political Quotes

“I thank the chairman. This year a typical senior will spend 15 percent of their household income on health care, including $620 plus on prescriptions. But that sum would be much higher if there were no FDA-approved generic pharmaceuticals. Without generics, that same senior might pay $1,000 for medicine, and Medicare would spend some $67 billion more. We must always assure that any medication, brand name or generic, is of the highest quality. But currently the Food and Drug Administration cannot assure that medicines coming in from overseas factories such as those in China are pure. This bill includes my legislation, the Generic Drug and Biosimilar User Fee Act, to authorize for the first time an FDA program that will expedite approval of generics and clear a backlog of over 2,800 generic applications. Currently, the FDA is supposed to make a decision on the application within 16 months. But the agency is taking twice that time because it lacks resources for conducting reviews and inspecting factories. U.S. factories are inspected perhaps once every 2 years, and more often if the FDA decides; foreign factories perhaps 7 to 9 years. That means millions of dosages of drugs coming in from overseas without any inspection. Recall what happened when heparin ended up killing perhaps 100 to 200 people and causing other complications for many people.…”