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Generic Company Disclosure Could Be A 'Speedbump' Against Misuse Of US FDA Access Inquiry List

 
• By Sue Sutter

Generic companies might get more transparency than they bargained for if there is misuse of the public list of reference drugs they say they have trouble obtaining; at BIO annual meeting, FDA Commissioner Gottlieb also suggests VA procurement of brand drugs as possible alternative if innovators continue to hinder access for bioequivalence testing.

photographed close-up of road marking is located on the roadway, warning of the presence of the hump
FDA may look to slow any potential generic company rush to use the public list of reference listed drug inquiries to shame brand companies.

Generic companies have some incentive to protect US FDA's publicly available list of reference listed drug (RLD) access inquiries from becoming a shaming weapon against innovators because their own identities might be revealed as a preventive measure.

Speaking at the 2018 BIO International Convention in Boston June 7, FDA Commissioner Scott Gottlieb said the agency might implement a disclosure measure if it sees the list being used...

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