‘ We have to make sure the Amer­i­can pub­lic main­tains con­fi­dence in the FDA’

Modern Healthcare - - Q & A -

Dr. Robert Califf be­came com­mis­sioner of the Food and Drug Ad­min­is­tra­tion in Fe­bru­ary, a year af­ter join­ing the agency as head of med­i­cal prod­ucts and to­bacco reg­u­la­tion.

The 64-year-old car­di­ol­o­gist brings to the job more than three decades of ex­pe­ri­ence in clin­i­cal trial re­search at Duke Univer­sity Med­i­cal Cen­ter. Mod­ern Health­care re­porter Steven Ross John­son be­gan by ask­ing Califf about some of the con­tro­ver­sies that swirled around his nom­i­na­tion. This is an edited tran­script. (See p. 14 for a pro­file of Califf, who leads our rank­ing of the 50 Most In­flu­en­tial Physi­cian Ex­ec­u­tives and Lead­ers for 2016.)

Mod­ern Health­care: While your con­fir­ma­tion re­ceived bi­par­ti­san sup­port, sev­eral Demo­cratic law­mak­ers said the FDA hasn’t done enough on opi­oid abuse.

Dr. Robert Califf: They should be con­cerned and even up­set be­cause this is a mas­sive epi­demic with more peo­ple dy­ing from opi­oid over­dose or re­lated drugs than auto ac­ci­dents in the U.S. I un­der­stand their con­cerns and de­gree of pas­sion, but also would has­ten to say that the FDA is work­ing hard on this topic.

MH: What are your top three pri­or­i­ties on opi­oids?

Califf: We have a very spe­cific ac­tion plan that has a lot more than three items. You could sort of put them into buck­ets. First is re­duc­ing the over­pre­scrip­tion of opi­oids by pro­vid­ing prac­ti­tion­ers and pa­tients with bet­ter in­for­ma­tion. Sec­ond would be to pre­vent the deaths that are com­ing from overuse of opi­oids by mak­ing ther­a­pies like nalox­one avail­able on a broader ba­sis. Third would be the devel­op­ment of abuse-de­ter­rent for­mu­la­tions.

In the long term what we need is much more ef­fec­tive pain man­age­ment as a na­tional pri­or­ity and the devel­op­ment of other ther­a­pies that are ef­fec­tive that are not ad­dic­tive.

MH: What are your other top pri­or­i­ties?

Califf: The No. 1 pri­or­ity dur­ing the time that I have at the FDA is strength­en­ing the work­force. This means hir­ing top-notch peo­ple, be­cause the world is chang­ing so quickly with biotech­nol­ogy and in­for­ma­tion tech­nol­ogy com­ing to­gether into an ex­cit­ing revo­lu­tion­ary phase across the spec­trum from agri­cul­ture to food prod­ucts to med­i­cal prod­ucts.

It also in­cludes mak­ing the FDA as good of a place to work as pos­si­ble for the highly tal­ented peo­ple who are here. The FDA must eval­u­ate in­creas­ingly com­plex in­for­ma­tion to make good de­ci­sions on be­half of the pub­lic. So we need the best peo­ple, and that in­cludes keep­ing the pipeline full, but also keep­ing peo­ple happy when they work here.

The sec­ond big pri­or­ity is what I will call ev­i­dence gen­er­a­tion. We are in this amaz­ing time where most ev­ery­one in the U.S. has an elec­tronic health record. We have a mas­sive num­ber of reg­istries be­ing de­vel­oped that deal with med­i­cal prod­ucts. We have real-world in­for­ma­tion com­ing in from wear­able de­vices and so­cial me­dia. Cap­tur­ing that in­for­ma­tion, in­te­grat­ing it and mak­ing use of it is a big deal.

MH: Law­mak­ers over the past year have been push­ing to stream­line the FDA’s process for re­view­ing drugs and med­i­cal de­vices through the 21st Cen­tury Cures Act. Are there ways the agency could ex­pe­dite the re­view process with­out jeop­ar­diz­ing pub­lic safety?

Califf: We have to make sure the Amer­i­can pub­lic main­tains con­fi­dence in the FDA. If the doc­tor pre­scribes a drug or puts a de­vice in you, we don’t want the pub­lic to have to stop and think, “Is this OK?” So safety is the No. 1 is­sue at the FDA.

We are way ahead of other coun­tries in terms of speed of re­view for drugs. We don’t want any­one to be­lieve we are go­ing to ap­prove ev­ery­thing. Some things should not be ap­proved. The key is the time­line to reach that de­ci­sion. We are faster than other coun­tries, and the U.S. gets first mar­ket ac­cess more than any other coun­try.

With de­vices, we have had prob­lems. We don’t think our stan­dards have been too high. We think other coun­tries may need to up their stan­dards a bit.

MH: How about drugs?

Califf: We want to look at ev­ery pos­si­ble way to make things ef­fi­cient. But we don’t want to sac­ri­fice safety.

Dif­fer­ent dis­eases have

“You re­ally have to have a strong in­ter­nal com­pass in this job to make sure that you keep your eye on do­ing the right thing.”

dif­fer­ent needs, and dif­fer­ent prod­ucts have dif­fer­ent needs. If we look at what is hap­pen­ing in on­col­ogy, we have four dif­fer­ent ways that things are ex­pe­dited. Some­times they are all used in com­bi­na­tion when it re­ally is a break­through. We have been very re­spon­sive to pa­tients (in) giv­ing ac­cess more quickly. It is a very rea­son­able thing to do. Then we have to make sure we have a great post-mar­ket sys­tem and there is a lot of en­ergy go­ing into that.

MH: How do you plan to re­vamp the FDA’s post-mar­ket sur­veil­lance of med­i­cal de­vices? What role do you see the unique de­vice iden­ti­fier pro­gram play­ing within that?


This is a very high pri­or­ity for me. Much of my his­tory as a car­di­ol­o­gist was spent de­vel­op­ing reg­istries for de­vices and pro­ce­dures. And I am very aware of the tremen­dous value that can come from hav­ing a sys­tem­atic ap­proach to as­sess­ing tech­nolo­gies as op­posed to a more hap­haz­ard ap­proach, which was the way much of it was done in the past when we de­pended on in­di­vid­ual clin­i­cians de­tect­ing ad­verse events and re­port­ing them.

We are in an era now where we can use ex­ist­ing data sources. It’s hap­pen­ing in drugs through the Sen­tinel sys­tem. Congress told us some years ago to de­velop a sys­tem­atic ap­proach to look­ing at elec­tronic claims data for over 100 mil­lion Amer­i­cans. It is used to check out safety sig­nals when they oc­cur. What we want is some­thing sim­i­lar for de­vices.

MH: What about adding unique de­vice in­den­ti­fier codes onto Medi­care claims?


It is essen­tial that we have UDIs. We are work­ing with CMS to get this done as quickly as we can. For high­risk de­vices, we can use reg­istries in com­bi­na­tion with EHRs to get a lot of this data. But it would prob­a­bly sur­prise a lot of Amer­i­cans to know that that is not hap­pen­ing now. We re­ally see a need to make this hap­pen, but it is com­pli­cated.

MH: There is a back­log on generic drug re­views. What are you do­ing to lessen that back­log?


There was no fund­ing for deal­ing with generic drugs un­til re­cently. We have de­vel­oped a sys­tem­atic ap­proach to the back­log. There is no back­log for new ap­pli­ca­tions now. What we have are some piled up old back­log ap­pli­ca­tions where we pri­or­i­tized the one where there was not an avail­able generic on the mar­ket or there was a spe­cial rea­son to put it at the front of the queue. Now that the fund­ing has kicked in, we are rapidly work­ing through the back­log.

MH: What ad­vice did Dr. Mar­garet Ham­burg, your pre­de­ces­sor, give you?


When I talked with Dr. Ham­burg be­fore com­ing to the FDA, she gave me a lot of ad­vice tied to the ex­pe­ri­ence that she was hav­ing. She gave me very sage ad­vice about how to stay calm in the face of many things go­ing on around you in which very hard de­ci­sions need to be made, where re­gard­less of the de­ci­sion, some­body is go­ing to be dis­ap­pointed.

You re­ally have to have a strong in­ter­nal com­pass in this job to make sure that you keep your eye on do­ing the right thing, de­spite all the pres­sures and the dis­ap­pointed peo­ple when things didn’t go their way.

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