A Few Observations About Rob Califf’s Picnic With The US Senate

I’m no expert on Washington politics but judging from the senate committee hearing today Rob Califf is going to be the next FDA commissioner. With the exception of Bernie Sanders, who had already announced his opposition, the committee members treated Califf with kid gloves. [Click here to read my live blog of the hearing.]

Lamar Alexander, the Chairman of the Health, Education, Labor and Pension Committee, started off the hearing by saying that his staff had found nothing that would stand in the way of the nomination and that he didn’t think there would be any big delays in taking action on the nomination.

Sanders, by contrast, said that the FDA has “been extraordinarily weak in regulating the pharmaceutical industry.” Califf, he concluded, “is not the person to stand up to pharma.” But the others senators seemed convinced that Califf had all the necessary qualifications.

Most senators appeared to accept Califf’s case that although he has worked closely with industry over the years he has always maintained strict independence. Califf said that the DCRI (Duke Clinical Research Institute) had lost a large percentage of trials because of its refusal to cede control of trials to industry. To demonstrate this independence Califf said that the committee would be given copies of the DCRI’s contracts with industry.

Califf didn’t directly address how he would respond to the problem of high drug prices, though this was perhaps the most frequently asked question. The question was raised not only by Sanders but several other senators, though it was pointed out several times that the FDA has no authority to regulate drug prices. However, it was also noted that there are many actions the FDA can take that will have an effect on prices. Califf pointed to increased support for generics as one important measure but he did not support Sanders call for permitting drug reimportation from other countries to fight high drug costs.

Much to my surprise, the recent controversies involving Turing and Valeant were only mentioned briefly. Califf deftly deflected any substantive response to these complex cases.

Regulatory Burden: Guidance Versus Rules

Two Republican senators, Alexander and Isakson, asked Califf whether he agreed that the FDA should get out of the business of issuing “guidance” and instead stick to firm “rules.” The not-so-hidden subtext here is the Republican agenda to reduce the burden on industry from government regulators.  Califf pointed out that there’s actually a big demand from industry for guidance, and that in any case FDA guidance is not legally binding.

The opposing view was expressed by Senator Warren, who asked Califf whether he agreed with those who think the FDA is too tough and should lower its standards. Califf avoided the political dangers of the question and tried to satisfy both sides by stating that he’s always been in favor of raising standards, but that the regulatory burden can actually be reduced by allowing better and faster trials. (Warren responded to note that we could abolish the FDA tomorrow and we’d see a lot of new products but that we’d also then have a lot of new problems.)

Califf has always been one of the leading proponents of large, simple, and practical randomized controlled trials, so it was no surprise that he returned to this topic on several occasions. Califf said that EHRs can be used to facilitate these trial and this could help reduce the cost of drugs by lowering their development cost. (Califf didn’t mention it during the hearing but one controversial idea related to this proposal is that informed consent may not be required from some patients in some of these trials.)

One fascinating moment was at the end of Senator Orin Hatch’s questions. Hatch is undoubtedly the biggest champion of supplements, and he is largely responsible for current laws which strictly limit the FDA’s ability to regulate supplements. Hatch asked Califf if he believed the FDA had enough authority to regulate supplements. Califf refused to answer and instead responded that the FDA is very aware of its statutory authority regarding supplements.

At other points Califf was able to deftly deflect questions about his specific views about FDA policy regarding topics like smokeless tobacco, food regulation, and drugs for children.

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