dr. califf. we'll now begin five-minute round. dr. califf, around the country and in congress, there's lots of talk about high cost of pharmaceutical drugs. do you believe in terms of drugs that it's accurate to say that the fda's statutory mission is to promptly and efficiently make sure that drugs are safe and effective? >> as you know, senator alexander, that is our primary mission but we also can have an impact on the cost of drugs by performing that function effectively. >> let me talk about that just a little bit. do you agree that it's not your job to set the price of drugs? >> it is not our job to set the price of drugs. >> let's talk about generic treatments. if generic treatments can move more rapidly through the fda process in a safe and effective way, that would be one way to create more competition and presumably lower the cost of drugs. despite getting about $1 billion in new funds over the last three years, generic manufacturers estimate that the fda's meeting approval time for generic drugs has gone from 30 months in 20

dr. califf. that that type of expenditure has any time of impact on the fact that we pay by far the highest prices in the world for prescription drugs. >> senator sanders, the ideal situation would be in the money went into r&d to see if an adequate picture went to treatments. >> why do we pay the highest prices in the world for prescription drugs? >> i am not an expert on the price of drugs, senator sanders but i'm sensitive to the fact that in the field like cardiovas cl lar -- >> it doesn't matter what the drugs are because their patients can't afford them. let me ask you this simple question. as head of the fda, you will oversee the importation of food products, vegetables, fish from all over the world. we can import lettuce and tomato vegetables from farms all over the world, but somehow we cannot reimport from canada brand-name prescription drugs manufactured by the largest drug companies of the world. can you explain to me and do you support the re-importation of bran brand-name prescripti

dr. califf. this question will require just a short answer. will you take a look, if you're confirmed, at the fda's policy of issuing documents instead of rule making? i've talked to the director of the budget. it has some pretty strong policies and firm views on the difference between rule making, which involves consultation and is legally behinding, and guidances which are not legally binding. there is a bipartisan concern that agencies of the federal government, including fda, are issuing guidances as if they were legally binding. >> senator, i will commit to working with you on that and taking a careful look at that. >> i want you to comment on a management issue at fda. we hear even when products are similar, experiences of applicants varies quite a bit. regulated parties ought to be treated in consistent and predictable ways. why do you think that even with similar products the experience of some applicants is so different, and what could you do to make sure regulated parties are treated in

dr. califf. senator murray. >> thank you, mr. chairman. dr. , in contrast to some of our previous fda nominees who have come from the public health sector, you are a physician and a researcher with a specialty in large clinical trials. as a result throughout your career, you have partnered extensively with pharmaceutical industries and i wanted to ask you some questions about that. during your past clinical trial and consulting work you've done, how have you ensured industry views have not biased your work, and what do you plan to do to ensure you are able to lead the fda without any undo influence? >> it's important to really divide this into two parts. the clinical trials we do, that we did during my tenure and still being done, if funded by indust industry, we have an iron clad contract which i believe your staff has a copy of that guarantees the independent right to publish, guarantees access to the database and in the majority of cases we actually have the database. we are running the trial. and we publish the papers with input from the co

dr. califf, was asked about importing drugs from canada. but he was specifically asked about branded medicine. he wasn't asked about generics. and the reason for that is because generics are more expensive by and large in canada than they are here in the u.s. i look forward to having the discussion around utilization and management and design. >> thank you very much, chip. next, andrea grandee, vice president of health benefits. andrea. >> thank you, susan. so as we heard today, drug trends are at double digits. in 2014, u.s. prescription costs increased 13.1%. and that was largely driven by specialty costs, unprecedented at 31%. while specialty costs only represents 1% to 2% of the volume, in the next few years, its financial impact will be more than 50%. now, while specialty drugs actually come with a price, they have been life changers. over the last 100 years, life expectancy has increased from 47 to 78 years. and in only the last 20 years, death related to hiv have decreased 80%. that's related to cancer have decreased 20%, and hepatit