Doug In­gram’s de­ci­sion to step down as Sarep­ta’s CEO by year's end was a shock­er, con­sid­er­ing his nev­er-say-die rep­u­ta­tion.

But af­ter a ter­ri­ble year and a tank­ing share price, Sarep­ta's next leader will have the chance to turn around one of biotech's most con­tro­ver­sial names.

In his near-decade at the helm of the Duchenne mus­cu­lar dy­s­tro­phy drug­mak­er, In­gram, 63, be­came a con­tentious fig­ure in the rare dis­ease field. But with pa­tient ad­vo­cates back­ing Sarep­ta (as well as a boost from for­mer FDA leader Pe­ter Marks), his com­pa­ny won three new drug ap­provals us­ing lim­it­ed and of­ten murky da­ta, gen­er­at­ing bil­lions in rev­enue.

The FDA has been us­ing an out­side in­ves­ti­ga­tor in a probe of work­place com­plaints against CBER Di­rec­tor Vinay Prasad, a source fa­mil­iar with the mat­ter told End­points News.

Among com­plaints made against Prasad are that he cre­at­ed a tox­ic work­place, ver­bal­ly be­rat­ed staff and re­tal­i­at­ed against staff push­back, three FDA of­fi­cials fa­mil­iar with the ac­cu­sa­tions told End­points. One source de­scribed the FDA in­quiry in­to Prasad as sprawl­ing and go­ing on for months.

The out­side firm, called Pro­fes­sion­al EEO Ser­vices, has been as­sist­ing with the FDA’s probe, ac­cord­ing to the first source, who spoke to End­points on con­di­tion of anonymi­ty. The source said that Prasad was ex­pect­ed to meet with the in­ves­ti­ga­tor this week, though trav­el is­sues dur­ing an East Coast bliz­zard may have de­layed that, the source added.

Rare dis­ease ad­vo­cates and sen­a­tors said they want to see more con­sis­ten­cy in the FDA’s ap­proval process dur­ing an Ag­ing Com­mit­tee hear­ing Thurs­day that ex­am­ined how the agency’s reg­u­la­to­ry process­es have led to de­lays for some ther­a­pies.

Law­mak­ers on both sides of the aisle dis­cussed their frus­tra­tions with the FDA, in­clud­ing the agen­cy's in­abil­i­ty to hire new staff and a re­cent slate of re­jec­tions of rare dis­ease treat­ments. 

“These pa­tients de­pend on a reg­u­la­to­ry process that’s sci­ence-dri­ven and ca­pa­ble of turn­ing re­search in­to re­al treat­ment,” Sen. An­gela Al­so­brooks (D-MD) said. “This ad­min­is­tra­tion is con­stant­ly dis­rupt­ing clin­i­cal tri­als, slow­ing in­no­va­tion and un­der­min­ing the pipeline to cures.”

The FDA green­lit an ex­pand­ed la­bel for Boehringer In­gel­heim’s lung can­cer drug Hernex­eos, mark­ing the first use of the Com­mis­sion­er's Na­tion­al Pri­or­i­ty Vouch­er for a new in­di­ca­tion.

Boehringer won an ac­cel­er­at­ed ap­proval for use of Hernex­eos in ad­vanced non-small cell lung can­cer pa­tients with cer­tain HER2 mu­ta­tions who haven’t pre­vi­ous­ly been treat­ed. In Au­gust, the agency grant­ed