FDA halts inspections.

[Hearthrob]

March 17, 2020 04:38 PM EDT
RegulatoryCoronavirus

Con­tract man­u­fac­tur­er: FDA has halt­ed do­mes­tic phar­ma in­spec­tions

The FDA ap­pears to have halt­ed its do­mes­tic in­spec­tions of phar­ma­ceu­ti­cal fa­cil­i­ties, al­though not be­fore at­tempt­ing to in­spect a con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion (CD­MO) on Mon­day and sub­se­quent­ly de­cid­ing to end the in­spec­tion ear­ly and an­nounce the halt.

The CEO of the CD­MO, who re­quest­ed that he and his firm re­main anony­mous, ex­plained to Fo­cus via email how his com­pa­ny re­ceived a last-minute in­spec­tion re­quest from an FDA in­spec­tor whose planned trip for in­spec­tions in Eu­rope was can­celed.

Last Fri­day af­ter­noon, the in­spec­tor al­leged­ly called the CD­MO to say he would be com­ing in for a post-ap­proval in­spec­tion on two gener­ic drugs. The CEO said he did not un­der­stand the need for the in­spec­tion as the site had re­ceived a pre-ap­proval in­spec­tion and gen­er­al in­spec­tion in Jan­u­ary 2019, so the com­pa­ny did not ex­pect an­oth­er in­spec­tion for two or three years.

But the FDA in­spec­tor ar­rived alone on Mon­day morn­ing, the CEO said, and the com­pa­ny firm­ly ex­pressed its op­po­si­tion to the in­spec­tion at that time as it could put him­self and about 15 com­pa­ny em­ploy­ees at risk due to Covid-19. The CEO not­ed that there did not ap­pear to be a need for the post-ap­proval in­spec­tion of these gener­ics as there were no in-mar­ket is­sues or com­plaints, nor was there a con­vinc­ing need for a gen­er­al sys­tems in­spec­tion.

Nev­er­the­less, the in­spec­tor per­formed the in­spec­tion for be­tween two and three hours and then re­ceived a phone call to end the in­spec­tion, and he ver­bal­ly told the CD­MO that FDA is sus­pend­ing all do­mes­tic in­spec­tions.

An­oth­er US-based CD­MO that al­so sought to re­main anony­mous told Fo­cus that it was con­tact­ed Mon­day about the need for a brief FDA vis­it on Tues­day, but that was sub­se­quent­ly can­celed.

FDA has not re­spond­ed to a re­quest for com­ment on the halt to do­mes­tic in­spec­tions but this sto­ry will be up­dat­ed when it does.

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. Click here for more in­for­ma­tion.

AUTHOR
Zachary Brennan
managing editor, RAPS
[e-mail]

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[littlemissmartypants]

1. This is such a weird article, I don't know where to place it in my head.

Interesting journalist though. Thanks, Hearthrob.

[riversedge]

4. I was thinking the same. First there seemed to be a push by FDA to inspect the drugs --when

supposedly there was not need. ONLY ONE inspector came. Then a mysterious phone call and FDA left

Lets hope there is a follow up.

[C_U_L8R]

2. That seems like another stupid move by the Trumps

Or is it simply corrupt.

[intrepidity]

3. Because everything under Trump dies

His maladministration is loaded to the gills with incompetence galore.

[milestogo]

5. Repukes hate regulations, because they get in the way of making money

and they can never have enough.