Janet Woodcock (Credit: CQ Roll Call/AP)

For­eign drug in­spec­tions de­cline as FDA hir­ing strug­gles con­tin­ue

The US re­liance on im­port­ed phar­ma­ceu­ti­cals and in­gre­di­ents is ris­ing as for­eign drug fa­cil­i­ty in­spec­tions de­creased by about 10% from 2016 to 2018. Part of the rea­son for the de­cline: The US Food and Drug Ad­min­is­tra­tion (FDA) said it’s still strug­gling to hire new in­spec­tors.

Tes­ti­fy­ing be­fore a House sub­com­mit­tee on Tues­day, Janet Wood­cock, di­rec­tor of FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search, de­fend­ed the agency’s ap­proach and dis­cussed some of the vul­ner­a­bil­i­ties of its for­eign in­spec­tion pro­gram. She said FDA is look­ing to hire 50 new in­spec­tors, but there are dif­fi­cul­ties.

“Even if the Agency suc­ceeds in hir­ing a new in­ves­ti­ga­tor, it can take 1.5 to 2 years of train­ing to bring them to a ful­ly pro­fi­cient lev­el,” Wood­cock said in her writ­ten tes­ti­mo­ny. With just 12 for­eign-based drug in­ves­ti­ga­tors cur­rent­ly, FDA says 90% of its for­eign in­spec­tions are con­duct­ed by US-based in­spec­tors.

Greg Walden (R-OR) ques­tioned Wood­cock and point­ed to a new Gov­ern­ment Ac­count­abil­i­ty Of­fice (GAO) re­port that found FDA is not com­plet­ing enough for­eign drug in­spec­tions, can­not hire enough in­spec­tors and that it pro­vides up to 12 weeks no­tice for some over­seas in­spec­tions. He al­so not­ed that FDA pre­vi­ous­ly con­duct­ed unan­nounced for­eign drug man­u­fac­tur­ing in­spec­tions but this ini­tia­tive was dis­con­tin­ued in 2015.

Wood­cock, mean­while, said more work is need­ed on the stan­dard­iza­tion of the in­spec­tion pro­gram. There is stan­dard­iza­tion for what in­spec­tors do and how they doc­u­ment it, she said, and “we’re chang­ing to a more mod­ern, stan­dard­ized process, which we’ve been able to com­plete for ster­ile prod­ucts.”

Mary Deni­gan-Macauley, di­rec­tor of health care at GAO, al­so tes­ti­fied on Tues­day that FDA rou­tine­ly gives for­eign drug man­u­fac­tur­ers sig­nif­i­cant ad­vanced no­tice of over­seas in­spec­tions, while the agency does not an­nounce many do­mes­tic in­spec­tions. But she said in­spec­tors face oth­er chal­lenges over­seas, with sin­gle in­spec­tors some­times cov­er­ing mul­ti­ple fa­cil­i­ties across acres of land. In­ves­ti­ga­tors al­so may have to use a man­u­fac­tur­er’s trans­la­tors and there can be un­cer­tain­ty about the ac­cu­ra­cy of cer­tain trans­la­tions.

Do­mes­tic and over­seas in­spec­tions need to be sim­i­lar, Deni­gan-Macauley said.

Wood­cock not­ed that for­eign com­pa­nies are no­ti­fied ahead of some in­spec­tions be­cause they usu­al­ly in­volve mul­ti­ple in­spec­tors com­ing over from the US, and the no­ti­fi­ca­tion is meant to en­sure those fa­cil­i­ties will be open.

Wood­cock al­so point­ed to plans at FDA to cre­ate in­cen­tives for man­u­fac­tur­ers to in­vest in prod­uct qual­i­ty. Part of such plans is to de­vel­op and im­ple­ment a rat­ing sys­tem for qual­i­ty man­age­ment ma­tu­ri­ty based on ob­jec­tive cri­te­ria. “Such a rat­ing sys­tem could en­able pur­chasers to com­pare dif­fer­ences in qual­i­ty and choose whether to re­ward more re­li­able man­u­fac­tur­ers fi­nan­cial­ly and with in­creased mar­ket share,” Wood­cock said in her writ­ten tes­ti­mo­ny.

On the is­sue of qual­i­ty, Rep. David McKin­ley (R-WV) asked Wood­cock if the gener­ic drug sup­ply is safe. And she as­sured him that FDA stands be­hind gener­ic drugs and that the agency has good safe­ty sys­tems in place. Com­pound­ed drugs, how­ev­er, is an area where prob­lems are oc­cur­ring, she added.

RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. 


Zachary Brennan

managing editor, RAPS

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