Orrin Hatch: “after listening to our debate today, it strikes me that the agriculture appropriations bill is really fundamental to the…”

“after listening to our debate today, it strikes me that the agriculture appropriations bill is really fundamental to the heart of the Food and Drug Administration [FDA] reform initiative that so many of us in the Congress believe is drastically needed. I think that a majority of Americans would be surprised, perhaps even shocked, to learn that the FDA routinely ignores deadlines set forth in the law, deadlines for reviews of products vital to public health such as approvals of new medical devices or generic drugs. The committee, in fact, recognized this disregard of the law and its dramatic impact in its report this year. The committee noted in part: The Committee expects the FDA to meet statutory review times for the review and approval of various food, drug and device applications and petitions . . . Extensive testimony has been presented about how the delay in approval of new drugs and medical devices has hurt American public health because U.S. patients do not have access to the latest technologies. Also, slow approval times are driving research and manufacturing jobs in these industries overseas, where earlier approvals are routinely expected. The committee went on to say: The problem is this agency often disregards its statutory obligation to approve or deny various applications and petitions within specified timeframes. As a result, many applications disappear into FDA for years.…”