FDA pushes to help generic drugs

San Francisco Chronicle Late Edition - - BUSINESSREPORT - By Sheila Ka­plan

Phar­ma­ceu­ti­cal com­pa­nies that spend bil­lions to de­velop drugs do not want com­peti­tors to profit from in­ex­pen­sive generic copies of block­buster medicines. So they fight for patent ex­ten­sions, seek new uses for old prod­ucts and, some­times, pre­vent generic drug com­pa­nies from ob­tain­ing sam­ples.

Dr. Scott Got­tlieb, the com­mis­sioner of the Food and Drug Ad­min­is­tra­tion, calls this “gam­ing the sys­tem,” and has vowed to stop it as part of the gov­ern­ment’s campaign to lower drug prices.

On Thurs­day, the FDA took a new tack and be­gan post­ing a list of mak­ers of brand-name drugs that have been the tar­get of com­plaints to per­suade them to “end the shenani­gans,” in the com­mis­sioner’s words.

Got­tlieb calls it trans­parency, but this ap­proach is bet­ter known among ethi­cists as nam­ing and sham­ing.

Con­gres­sional efforts to force the com­pa­nies to hand over sam­ples of their drugs to generic com­peti­tors have not been suc­cess­ful. Re­cent pro­pos­als to en­sure generic ac­cess to drug sam­ples would save the fed­eral gov­ern­ment $3.8 bil­lion over 10 years, ac­cord­ing to the Con­gres­sional Bud­get Of­fice, partly by low­er­ing Medi­care and Med­i­caid spend­ing on pre­scrip­tion drugs.

The Fed­eral Trade Com­mis­sion has also been in­ves­ti­gat­ing the prac­tice.

Some brand-name drug­mak­ers say the leg-

is­la­tion is not needed. The FDA has been speed­ing up ap­proval of generic drugs, and nearly 90 per­cent of pre­scrip­tions are filled with gener­ics.

But oth­ers point to the ways in which ma­jor phar­ma­ceu­ti­cal com­pa­nies have man­aged to keep patents on cer­tain ex­pen­sive drugs for years longer than nec­es­sary.

Generic drug de­vel­op­ers usu­ally need 1,500 to 5,000 units of the brand drug to de­velop their prod­uct and test it, to show that it is ef­fec­tive and can be ab­sorbed at the same rate as the brand drug, ac­cord­ing to the agency. Both the FDA and the Fed­eral Trade Com­mis­sion say se­cur­ing the sam­ples can be dif­fi­cult, be­cause ma­jor drug firms can in­voke safety con­cerns — real or un­real — to avoid pro­vid­ing the ma­te­ri­als.

The FDA’s new list in­cludes drug com­pa­nies the agency said may be pur­su­ing gam­ing tac­tics to de­lay generic com­pe­ti­tion. Along with the name of each busi­ness, the agency noted how many in­quiries it re­ceived from generic drug com­pa­nies seek­ing sup­plies. The names of the generic com­pa­nies were not pro­vided.

While Cel­gene tops the list, other com­pa­nies that the FDA named as the sub­ject of com­plaints in­clude Glax­o­SmithK­line, Pfizer, Valeant Phar­ma­ceu­ti­cals In­ter­na­tional, No­vato’s BioMarin Phar­ma­ceu­ti­cal, Fos­ter City’s Gilead Sci­ences and No­var­tis Phar­ma­ceu­ti­cals.

Cel­gene, which makes drugs to treat can­cer and im­mune-in­flam­ma­tory dis­eases, was named as the sub­ject of 31 in­quiries from com­pa­nies seek­ing ac­cess to Revlimid (lenalido­mide), its treat­ment for mul­ti­ple myeloma and re­lated dis­eases; Po­m­a­lyst (po­ma­lido­mide); and Thalo­mid (thalido­mide).

Cel­gene has been em­broiled in law­suits for sev­eral years with com­pa­nies seek­ing ac­cess to the drugs. It re­cently sued Dr. Reddy’s Lab­o­ra­to­ries Ltd., an In­dian com­pany, to block it from sell­ing generic copies of Revlimid, the com­pany’s big­gest prod­uct, and has been fend­ing off an at­tempt by My­lan to also get into the generic Revlimid busi­ness. At a court hear­ing last year, a lawyer for My­lan, Jonathan M. Ja­cob­son, told a fed­eral dis­trict judge that the drug costs dy­ing pa­tients $20,000 a month — a price that would de­cline if gener­ics were avail­able.

Greg Geiss­man, a spokesman for Cel­gene, said the com­pany had not prevented generic com­pa­nies from ob­tain­ing their prod­ucts.

“We have sold and will sell our ground­break­ing prod­ucts to generic man­u­fac­tur­ers for the pur­poses of bioe­quiv­a­lence test­ing, sub­ject to rea­son­able safe­tyre­lated and busi­ness re­quire­ments,” Geiss­man said. “Generic ver­sions of Thalo­mid and Revlimid are ex­pected to en­ter the mar­ket in com­ing years.”

Geiss­man also said that Cel­gene sup­ports fed­eral efforts to pro­mote ac­cess to sam­ples at rea­son­able prices, as long as there is ap­pro­pri­ate safety and li­a­bil­ity pro­tec­tion for the seller.

The next big­gest tar­get, with 26 in­quiries, is Acte­lion Phar­ma­ceu­ti­cals Ltd., a John­son & John­son com­pany, which is ac­cused of block­ing ac­cess to four drugs. There were 14 in­quiries about get­ting sup­plies of Tr­a­cleer (bosen­tan), a med­i­ca­tion pre­scribed for high blood pres­sure in the ves­sels of the lungs, known as pul­monary ar­te­rial hyper­ten­sion. The FDA also re­ceived eight com­plaints about lack of ac­cess to Op­sumit (maci­ten­tan), which is also used to treat pul­monary ar­te­rial hyper­ten­sion. There were also sev­eral com­plaints about a lack of ac­cess to Acte­lion’s Zavesca (miglu­s­tat) and Veletri (epoprostenol sodium). Veletri is also used to treat pul­monary ar­te­rial hyper­ten­sion and Zavesca is in­di­cated for Gaucher dis­ease.

An av­er­age one-month sup­ply of Tr­a­cleer costs just over $12,000, and a sup­ply of Op­sumit runs $8,900 to $10,000, ac­cord­ing to GoodRx, which tracks drug prices. Both prices are based on the pa­tient pre­sent­ing a free dis­count coupon.

Many phar­ma­ceu­ti­cal com­pa­nies sell both brand-name and generic drugs, lead­ing to a sit­u­a­tion in which a com­pany like My­lan, still fight­ing Cel­gene in court, can be on the re­ceiv­ing end of generic com­pany com­plaints.

The FDA’s list of shame notes three in­quiries from com­pa­nies try­ing to get ac­cess to My­lan’s Amnes­teem (isotretinoin), used to treat se­vere cys­tic acne that has not re­sponded to an­tibi­otic treat­ment.

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