Scru­ti­niz­ing a drug reg­u­la­tor’s ties to in­dus­try

Modern Healthcare - - POLITICS - —Steven Ross John­son

The Obama ad­min­is­tra­tion’s de­ci­sion to name Dr. Robert Califf the next com­mis­sioner of the U.S. Food and Drug Ad­min­is­tra­tion re­mains steeped in con­tro­versy. He spent most of his ca­reer as a clin­i­cal re­searcher en­gaged in phar­ma­ceu­ti­cal in­dus­try-funded clin­i­cal tri­als.

Califf joined the FDA as deputy com­mis­sioner last March af­ter 30 years as a med­i­cal re­searcher at Duke Univer­sity School of Medicine. He was im­me­di­ately charged with over­see­ing the agency’s of­fice han­dling drugs, med­i­cal devices and to­bacco prod­ucts.

While at Duke, Califf gained the ex­pe­ri­ence and ex­per­tise to head the FDA. He is cred­ited with lead­ing its ef­forts to im­prove re­search pro­cesses, and helped de­velop and lead the na­tional Pa­tient-Cen­tered Out­comes Re­search Net­work, an ini­tia­tive to en­hance the qual­ity of clin­i­cal ev­i­dence used in guid­ing health de­ci­sions.

But crit­ics ques­tion Califf’s im­par­tial­ity in reg­u­lat­ing the phar­ma­ceu­ti­cal in­dus­try. As re­cently as 2014, his salary was sup­ple­mented by fund­ing from sev­eral drug com­pa­nies.

If con­firmed this week by the Se­nate, Califf will over­see an agency un­der mount­ing pres­sure from drug­mak­ers and law­mak­ers to stream­line its re­view process. The 21st Cen­tury Cures Act has re­ceived bi­par­ti­san sup­port, and pas­sage by a Congress look­ing to avoid the “do noth­ing” la­bel in this elec­tion year is a dis­tinct pos­si­bil­ity.

Con­sumer and safety ad­vo­cates fear the law’s re­lax­ation of FDA reg­u­la­tory stan­dards will come at the ex­pense of prod­uct safety and ef­fi­cacy. Califf’s in­ter­pre­ta­tion of the law, should it pass, will be closely watched.

“In the his­tory of the FDA, no other com­mis­sioner has had such a close fi­nan­cial re­la­tion­ship with big pharma as him,” said Dr. David Gortler, a for­mer FDA se­nior med­i­cal of­fi­cer who is now a drug safety and FDA pol­icy ex­pert. “There are dozens of other peo­ple who have re­search records equal to or su­pe­rior to Dr. Califf’s with­out the over­whelm­ing num­ber of con­flicts of in­ter­est.”

Pend­ing po­si­tion Com­mis­sioner des­ig­nate

Or­ga­ni­za­tion U.S. Food and Drug Ad­min­is­tra­tion

Cur­rent po­si­tion FDA deputy com­mis­sioner

Ten­ure in job

11 months Dr. Robert Califf

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