At­tack­ing drug short­ages

Modern Healthcare - - THE WEEK - FTC won’t chal­lenge plan to send data to FDA Ashok Sel­vam

The Fed­eral Trade Com­mis­sion paved the way for a generic-drug­mak­ers trade group to im­ple­ment a plan to sup­ply the Food and Drug Ad­min­is­tra­tion with man­u­fac­tur­ing data as part of a gov­ern­ment ef­fort to ad­dress drug short­ages.

FTC of­fi­cials penned an 11-page opin­ion let­ter last week say­ing the agency won’t chal­lenge the Generic Phar­ma­ceu­ti­cal As­so­ci­a­tion’s pro­posed ini­tia­tive, which in­volves pool­ing data from a num­ber of phar­ma­ceu­ti­cal com­pa­nies and then send­ing it to the FDA. Though the FTC had scru­ti­nized the plan for po­ten­tial an­titrust is­sues that could stem from phar­ma­ceu­ti­cal com­peti­tors gain­ing ac­cess to sen­si­tive man­u­fac­tur­ing data gath­ered through the ini­tia­tive, the agency con­cluded that the plan “is not likely to harm com­pe­ti­tion.”

GPhA pro­posed em­ploy­ing an in­de­pen­dent third party to col­lect and send the data to the FDA to en­sure no other party, in­clud­ing GPhA, would ac­cess that in­for­ma­tion. That safe­guard and oth­ers quelled the FTC’s an­titrust con­cerns.

The FTC’s Bureau of Com­pe­ti­tion has “no present in­ten­tion to bring an en­force­ment ac­tion to chal­lenge GPhA’s pro­posed ARI pro­gram if it is im­ple­mented as de­scribed and the safe­guards it con­tains are ad­hered to in prac­tice,” ac­cord­ing to the let­ter signed by FTC As­sis­tant Di­rec­tor Markus Meier.

With that an­nounce­ment, the plan’s roll­out should come soon, said David Gaugh, a se­nior vice pres­i­dent with the GPHA. Gaugh called the FTC’S ac­tion a huge pos­i­tive. The pro­gram also will ex­tend to phar­ma­ceu­ti­cal com­pa­nies that aren’t as­so­ci­a­tion mem­bers.

“We do have a few things that we need to flush out, and we are work­ing with the FDA,” Gaugh said. “I couldn’t pin­point a date, but within the com­ing weeks.”

GPHA se­lected Par­sip­pany, N.J.-head­quar­tered IMS Health as the third party that will re­view the data. IMS in­tends to col­lect data from drug com­pa­nies about their pro­jected and cur­rent pro­duc­tion and sup­ply sched­ules. The pro­gram ini­tially will fo­cus on ac­cel­er­at­ing the pro­duc­tion and avail­abil­ity of crit­i­cal drugs that are in short sup­ply, de­fined as drugs expected to be in short­age for more than 90 days with­out a ther­a­peu­tic al­ter­na­tive, ac­cord­ing to the Amer­i­can So­ci­ety of HealthSys­tem Phar­ma­cists. The pro­gram could even­tu­ally ex­pand to as­sist FDA of­fi­cials in work­ing to pre­vent po­ten­tial short­ages.

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