FDA lists drug firms ac­cused of block­ing gener­ics

Sun Sentinel Palm Beach Edition - - NATION & WORLD - By Linda A. John­son AP Med­i­cal Writer

TREN­TON, N.J. — U.S. drug reg­u­la­tors are pub­li­ciz­ing in­for­ma­tion on brand-name drug­mak­ers that use what gov­ern­ment of­fi­cials call “gam­ing tac­tics” to block cheaper copy­cat ver­sions.

The Food and Drug Ad­min­is­tra­tion’s new web­page names the mak­ers of more than 50 brand-name drugs, many car­ry­ing five- or six­fig­ure an­nual price tags, who are un­der scru­tiny. The agency also lists in­quiries it has re­ceived from generic drug­mak­ers re­quest­ing FDA’s help in get­ting ac­cess to the brand-name drugs, though not all the com­plaints have been ver­i­fied.

Generic drug com­pa­nies gen­er­ally re­quire 1,000 to 1,500 units, such as pills, of a brand-name drug to cre­ate much-cheaper drugs with iden­ti­cal ac­tive in­gre­di­ents and ef­fects.

The FDA said Thurs­day that brand-name drug­mak­ers some­times refuse to sell generic com­pa­nies drugs that may need ex­tra safety mon­i­tor­ing or bar drug whole­salers from sell­ing other medicines to generic drug­mak­ers.

“We hope that this in­creased trans­parency will help re­duce un­nec­es­sary hur­dles to generic drug de­vel­op­ment and ap­proval,” the FDA said in a state­ment.

De­layed launches of generic ver­sions of drugs whose patents have ex­pired usu­ally push higher costs onto pa­tients, em­ploy­ers and tax­pay­ers.

One drug­maker strat­egy — a lim­ited dis­tri­bu­tion net­work in which the com­pany only pro­vides its medicine to one or two whole­salers or phar­ma­cies in­stead of many dis­trib­u­tors — en­ables the maker to bet­ter con­trol and raise prices. That’s how for­mer Tur­ing Phar­ma­ceu­ti­cals CEO Martin Shkreli was able to hike the price of a 60-year-old anti-in­fec­tive drug, Dara­prim, from $13.50 to $750 per pill.

Sev­eral of the world’s largest drug­mak­ers were cited by FDA as hav­ing re­fused to sell more than one medicine to generic com­pa­nies, of­ten drugs long on the mar­ket that gen­er­ate bil­lions in an­nual sales. Those in­clude Switzer­land’s No­var­tis AG, cited for block­ing ac­cess to four medicines, and Sum­mit, N.J.-based Cel­gene Corp., cited for block­ing ac­cess to three drugs.

No­var­tis said in a state­ment that it “dis­agrees with the in­clu­sion of our prod­ucts on the list.” The com­pany said its drugs on the list have a generic ver­sion un­der FDA review.

Cel­gene said generic ver­sions of some of its drugs will reach the mar­ket “in com­ing years.” But the drug­maker said there needs to be a bet­ter process to en­sure the safety of generic ver­sions on the mar­ket since its three drugs on the list carry se­ri­ous risks in­clud­ing birth de­fects.

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