12:00 Hearing adjourned. It sure looks like Rob Califf will be our next FDA commissioner.
11:58 Scott asks about the high rate of heart disease and diabetes in South Carolina. The high cost of trials is preventing cures for these diseases. Califf asks how many hours he has to answer the question. Califf notes we have a lot of effective treatments already. But we’re committed to develop a better clinical trial system using EHRs that will be dramatically less expensive and with greater efficacy and safety. [But shouldn’t Califf have mentioned that heart disease and diabetes will never be conquered with drugs. This is ultimately a public health problem, not a medical issue.]
11:53: Califf updates the committee to state that the DCRI contracts with industry are being delivered to the senate staff.
11:40: Sanders: We have been extraordinarily weak in regulating the pharmaceutical industry. Califf is not the person to stand up to pharma.
11:38: Califf says he’s not an expert on drug prices. Sanders says we can import food and other products but not reimportation of drugs. Califf says we can’t be sure that brand name drugs can be safely imported. Sanders: “we can bring in vegetables and fish from all over the world but not brand name drugs.”
11:36: Sen Sanders is up! (Or is that Larry David?) Sanders repeats that he will not support the nomination, because of the huge high cost of drugs. The top 4 pharma companies made $57 billion in profits, while millions of people can’t afford the products. We need an FDA commissioner who understands that problem.
11:29: Hatch– of course the biggest champion of unregulated supplements– asks Califf if he thinks the FDA has enough authority to regulate supplements. Califf punts and says, and repeats, that the FDA is very aware of its statutory authority about supplements. (BTW, that was a real dick move by Hatch to ask the question at the very end of his allowed time.)
11:28: Hatch asks about LDTs– laboratory developed tests. Califf says that FDA is gathering info on this, especially next generation sequencing.
11:26: Sen. Hatch asks about reducing cost of development. Califf says that we think we can do trials that are bigger and cheaper. (Califf has always been a proponent of big practical trials.)
11:22: Regarding updating rules for generics, Califf says it’s a “high priority” to finish its work.
11:19: Sen. Franken revisits pharmaceutical costs. Califf says FDA needs to support generics, including in the biological space, since that’s a big expense, “when it’s appropriate.” Califf says that we can save money with precision medicine by giving drugs only when they will be helpful.
11:15: Sen. Cassidy mentions Turing and approval of generics. Surprised it took so long. Why is it easier for drugs to get approved in the compounding space but not as a generic. Califf says that we’re working hard on the standards of compounding. Cassidy now mentions Valeant. “Total exploitation of the system… these folks are frankly greedy.” I’m not sure Califf actually addressed the important issues of this question.
11:11: Asked by Baldwin about cranberry juice labels and added sugar, Califf says the FDA really needs to work “on the cognitive side of labelling.” Information needs to be clear or it can lead to the wrong decision.
11:09: Senator Baldwin asks how you would improve access to info about drugs. Califf says that every trial he’s been involved with has been published. Califf says that the surveillance system needs to be improved, especially for generics, since it’s unclear where the responsibility lies to follow very old generics.
11:05: So far the biggest disagreement so far is whether Sen Roberts U of Kansas is a better basketball team than Califf’s Duke.
11:00: Warren: do you agree who think the FDA is too tough and should lower its standards? [This is the key question today!] Califf says he’s always been in favor of raising standards, but that doesn’t mean we can’t do better or faster trials. Warren says we could abolish the FDA tomorrow and we’d see a lot of new products but that we’d also have a lot of new problems!
10:59: Upon further questioning from Warren, Califf says that industry is allowed input on analysis but the final decision is from DCRI. Warren says she’s requested copies of the contracts DCRI has signed with industry. (This could be VERY interesting.)
10:57: Senator Warren asks about his relationship with the drug industry and whether industry can exert influence on clinical trials. Califf says trial design at DCRI is done jointly with industry and academe. The data base is really the critical factor here, and all of our contracts insist that we keep the data. We’ve had to walk away from 70% of trials because of this demand. Finally, publications and presentations of data are completely independent.
10:53: Senator Isakson doesn’t like “guidance.” He wants FDA to make rules and not guidance. Califf responds that there’s actually a huge demand from industry and others for this guidance. Califf notes that guidance is not legally binding but it helps for industry to know this. Isakson repeats that FDA should concentrate on rules and not guidance. This is all about Republican efforts to reduce governmental burden.
10:49: Asked about health apps and new information devices Califf says he’s wearing a device now and it doesn’t need to be regulated. But if it were attached to an internal defibrillator– “don’t worry I don’t have one”– then it would be necessary to regulate it.
10:47: Califf says that as a cardiologist he lives and breathes in this space. Califf says there’s a strong view within the FDA that there is a need for another pathway, and that he agrees with this view. It will require legislative action. Califf says the FDA will need help to get the right balance.
10:45: Senator Whitehouse asks about drug/device combos. This must be a setup for Califf because he has talked about this topic extensively.
10:42: Senator Burr asks about “non-combustible tobacco products” that may be safer than cigarettes. Califf says FDA has recently hired hundreds of people to evaluate these products.
10:39: Murray question about post-market surveillance. Califf says FDA needs support from legislation to improve surveillance, especially on the device side. Cites examples of the problems with duodenoscopes– with a better system FDA might have spotted the problems earlier.
10:37: Califf says its critically important for FDA to critically evaluate industry products but that FDA and industry should work together in the “precompetitive space”.
10:35: Murray begins her questions. Asks Califf about his connections to industry and why this won’t bias him. Califf says that industry-funded trials he’s performed have iron-clad contracts that guarantee independence. “So yes, industry funds these trials but we have independence.”
10:33: Alexander asks whether FDA should concentrate on “rule-making” and not “guidance.” Califf says he will commit to talking about this subject. The sub-text here is the Republican interest in diminishing regulation and government burden.
10:31: Califf says most prescriptions today are generic. But there is a big backlog of generic applications, mostly because these applications are not high quality.
10:30: Alexander starts off with questions about the high cost of drugs and whether the primary mission of FDA is to ensure that drugs are safe and effective. Califf agrees that the FDA is not involved in setting prices. Alexander says that going easy on approving generics will help control costs.
10:23:Alexander says that each senator will have 5 minutes to ask questions or talk. Alexander starts to ask questions but then is reminded that Califf hasn’t had a chance to give his opening statement.
10:21 Senator Scott (SC) points out that though Califf is well known as a North Carolinian he was actually born in South Carolina.
10:19: Senator Burr is now introducing Califf. Califf’s entire family is behind him. Califf is “a great man.” Wow this is turning into a complete love-fest. Burr asks his colleagues to move the nomination “expeditiously.”
10:16: Murray says Califf is a “strong nominee” and appears to endorse him as well. Bipartisan support! FYI, I’m going to skip most of the speechifying and try to concentrate on real substance.
10:13: Minority chair Patty Murray talking about how important the FDA is.
10:09: Senator Alexander: said his staff says has found nothing that would stand in the way of nomination! I’m not a Washington observer but this sounds like it may be an easy ride for Califf. Alexander is praising Califf extravagantly.
10:07: Chairman of the Health, Education, Labor and Pension Committee Lamar Alexander kicks the session off. He starts by saying he doesn’t think there will be any big delays in taking action on his nomination.
I’ve been following Rob Califf’s career for more than 25 years. Here’s what I’ve written previously about his nomination:
- President Obama Nominates Cardiologist Rob Califf To Lead FDA
- Why Rob Califf Running The FDA May Be Like Nixon In China
- Possible Setback For Califf On Road To FDA
10:00 AM: Getting ready for the Senate hearing:
Here’s the committee list: