FDA sends warn­ing let­ter to My­lan over 'i­nad­e­quate' man­u­fac­tur­ing process­es at In­dia plant

My­lan has once again run afoul of the FDA over its lack of up­keep at man­u­fac­tur­ing plants.

For the sec­ond time in the last 12 months, the agency has sent a warn­ing let­ter to the gener­ic drug­mak­er call­ing out its fail­ure to main­tain in­dus­try-stan­dard clean­ing pro­ce­dures that pre­vent con­t­a­m­i­na­tion. In the let­ter, sent on Aug. 20 and pub­lished Tues­day, reg­u­la­tors al­so al­lege My­lan $MYL did not test in­com­ing API for im­pu­ri­ties, have mech­a­nisms in place to de­tect such im­pu­ri­ties from en­ter­ing prod­ucts, or keep clean­ing records for bulk stor­age tanks.

The FDA’s con­cerns arose dur­ing an in­spec­tion at a plant in In­dia last Feb­ru­ary.

“These re­peat­ed fail­ures at mul­ti­ple sites man­u­fac­tur­ing API demon­strate that your com­pa­ny’s over­sight and con­trol over the man­u­fac­ture of drugs is in­ad­e­quate,” wrote Fran­cis God­win, the di­rec­tor of the FDA’s Of­fice of Man­u­fac­tur­ing Qual­i­ty and Of­fice of Com­pli­ance at the Cen­ter for Drug Eval­u­a­tion and Re­search.

God­win al­so told My­lan, “You should im­me­di­ate­ly and com­pre­hen­sive­ly as­sess your com­pa­ny’s glob­al man­u­fac­tur­ing op­er­a­tions to en­sure that sys­tems and process­es, and ul­ti­mate­ly, the prod­ucts man­u­fac­tured, con­form to FDA re­quire­ments at all your sites.”

In­vestors re­act­ed some­what poor­ly to the news, send­ing My­lan shares down about 5% in Tues­day trad­ing. The stock showed a slight re­bound ear­ly Wednes­day, hov­er­ing around a 1.5% in­crease.

My­lan re­spond­ed with a state­ment say­ing that it does not fore­see any in­ter­rup­tions to oc­cur re­gard­ing man­u­fac­tur­ing or dis­tri­b­u­tion, as there are no “sig­nif­i­cant” launch­es com­ing out of the plant through the end of the year. “No sig­nif­i­cant com­mer­cial im­pact is ex­pect­ed,” My­lan said, and not­ed that af­ter a pre­vi­ous warn­ing let­ter sent in No­vem­ber 2019, the com­pa­ny “put ad­di­tion­al con­trols, cor­rec­tive ac­tions and im­prove­ments in place.”

“Im­por­tant­ly, ex­ten­sive test­ing of APIs man­u­fac­tured and dis­trib­uted by the site was per­formed for the pres­ence of ni­trosamine im­pu­ri­ties and no ev­i­dence of cross con­t­a­m­i­na­tion was iden­ti­fied,” the state­ment went on.

That No­vem­ber let­ter ul­ti­mate­ly prompt­ed the Feb­ru­ary in­spec­tions af­ter the FDA found “poor con­trol” of sol­vents at a sep­a­rate man­u­fac­tur­ing plant in In­dia. God­win wrote at the time that sim­i­lar sub­stan­dard clean­ing prac­tices and im­pu­ri­ty test­ing al­leged­ly took place.

The warn­ing let­ter puts a dent in a large­ly suc­cess­ful last few months for My­lan, which in late Ju­ly earned a win in the courts as an in­junc­tion block­ing its Tec­fidera gener­ic was lift­ed. Though the com­pa­ny would still be fil­ing for an ap­proval at-risk, giv­en that Tec­fidera mak­er Bio­gen is ap­peal­ing, My­lan has asked the FDA to move up its PDU­FA date from No­vem­ber.

Tec­fidera racked up $4.4 bil­lion in 2019 sales for Bio­gen, and if even some of that pie heads My­lan’s way, it could see a sig­nif­i­cant wind­fall.

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