Agency starts name-and-shame campaign on drug com­pa­nies and gener­ics

The Washington Times Daily - - POLITICS - — Tom How­ell Jr.

Mov­ing to implement Pres­i­dent Trump’s drug-pric­ing plan, the Food and Drug Ad­min­is­tra­tion on Thurs­day started nam­ing brand­name drug mak­ers who shut out com­pe­ti­tion by pre­vent­ing generic mak­ers from ob­tain­ing sam­ples of their prod­uct.

FDA Com­mis­sioner Scott Got­tlieb said a generic man­u­fac­turer typ­i­cally needs 1,500 to 5,000 units of the brand drug to per­form the tests needed to win reg­u­la­tory ap­proval of their prod­ucts, yet more than 150 generic drug de­vel­op­ers have com­plained to the agency about tac­tics that shut them out.

The FDA pub­lished the names of dozens of com­pa­nies that may have been block­ing ac­cess, hop­ing sun­shine will change their be­hav­ior.

“We hope that this in­creased trans­parency will help re­duce un­nec­es­sary hur­dles to generic drug de­vel­op­ment and ap­proval,” Dr. Got­tlieb said.

The FDA said com­pa­nies are us­ing a va­ri­ety of tac­tics to stall the sale of gener­ics.

They may cite the pres­ence of a Risk Eval­u­a­tion and Mit­i­ga­tion Strat­egy (REMS) — a pro­gram the FDA ap­plies to cer­tain drugs to en­sure their ben­e­fit out­weigh their risks — to refuse dis­tri­bu­tion, or im­pose con­di­tions on sales that generic mak­ers can­not meet.

Oth­ers brand com­pa­nies put re­stric­tions in their con­tracts with drug dis­trib­u­tors, whole­salers or spe­cialty phar­ma­cies to pre­vent those in­ter­me­di­aries from sell­ing sam­ples to generic mak­ers.

“I want to be very clear: A path to se­cur­ing sam­ples of brand drugs for the pur­pose of generic drug de­vel­op­ment should al­ways be avail­able,” Dr. Got­tlieb said.

AS­SO­CI­ATED PRESS

“I want to be very clear: A path to se­cur­ing sam­ples of brand drugs for the pur­pose of generic drug de­vel­op­ment should al­ways be avail­able,” Food and Drug Ad­min­is­tra­tion Com­mis­sioner Scott Got­tlieb said as he moves to implement Pres­i­dent Trump’s...

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