In­dus­try in Panic Over Fall­out of FDA Note on In­dian Firm’s Data In­tegrity

Some large In­dian drug cos may feel im­pact of call to re­peat some stud­ies, say sec­tor in­sid­ers

The Economic Times - - Companies: Pursuit Of Profit -

Vikas Dan­dekar & Prabha Ragha­van

Mum­bai|New Delhi: A note from the US Food and Drug Ad­min­is­tra­tion (FDA) in­form­ing drug com­pa­nies last week about data in­tegrity con­cerns at Sem­ler Re­search has sent panic sig­nals across the In­dian phar­ma­ceu­ti­cal in­dus­try. The US agency had called drug firms to re­peat cer­tain stud­ies ear­lier done by Sem­ler, adding that the stud­ies sub­mit­ted from the con­tract re­search or­gan­i­sa­tion (CRO) out­fit will not be ac­cept­able.

In its note, the FDA said it is tak­ing the ac­tion based on its in­spec­tions be­tween Septem­ber 29 and Oc­to­ber 9 last year, but did not spec­ify a time frame for which the stud­ies will have to be re­peated. The drug com­pa­nies that may be im­pacted bythe lat­est ac­tion could not be iden­ti­fied im­me­di­ately but top sources in the CRO in­dus­try said a few large In­dian drug mak­ers may feel the im­pact. Gen­er­ally, drug firms out­source sev­eral projects (bioavail­abil­ity/bioe­quiv­a­lence stud­ies) at any given time to sev­eral CROs, based on their track record of qual­ity and de­liv­ery within set deadlines. While most com­pa­nies farm out work to ex­ter­nal agen­cies, some do piece­meal work us­ing in­ter­nal re­sources.

“For each new fil­ing or gen­er­at­ing new data, a com­pany needs at least 8 to 9 months and it costs up to $1,00,000,” said an in­de­pen­dent con­sul­tant, ask­ing not to be iden­ti­fied. He men­tioned that in some term sheets signed with the CROs, com­pa­nies have started to in­clude in­dem­ni­fi­ca­tion clauses in the le­gal con­tracts that cover loss of mar­ket share and ad­di­tional costs for re­peat­ing stud­ies.

The FDA in­spec­tions had found sig­nif­i­cant in­stances of mis­con­duct and vi­o­la­tions of fed­eral reg­u­la­tions, in­clud­ing sub­sti­tu­tion and ma­nip­u­la­tion of study sub­ject sam­ples.

In its re­sponse to ET, a US FDA spokesper­son de­clined to share in­for­ma­tion re­gard­ing the af­fected com­pa­nies. It noted, “Fed­eral law pre­vents us from dis­clos­ing in­for­ma­tion re­lated to con­tracts be­tween spon­sors and third par­ties such as cont- ract re­search or­ga­ni­za­tions (CROs), and iden­ti­fy­ing the af­fected drug prod­ucts would re­veal that in­for­ma­tion….Fed­eral law also pre­vents us from com­ment­ing on pend­ing ap­pli­ca­tions.”

The FDA said Sem­ler con­ducts bioe­quiv­a­lence and bioavail­abil­ity stud­ies for a num­ber of phar­ma­ceu­ti­cal com­pa­nies. While the lat­est ac­tion by the US reg­u­la­tor did not spec­ify a need to with­draw the ex­ist­ing prod­ucts from the mar­ket, the direc­tive to re­peat the stud­ies could mean a tem­po­rary dis­rup­tion in sup­ply of the prod­ucts be­sides an un­ex­pected fi­nan­cial stress for the drug com­pa­nies that will have to re­peat the stud­ies for re­sub­mis­sions. The in­spec­tion found sig­nif­i­cant in­stances of mis­con­duct and vi­o­la­tions of fed­eral reg­u­la­tions, in­clud­ing the sub­sti­tu­tion and ma­nip­u­la­tion of study sub­ject sam­ples.

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