Why FDA can’t dis­close the first coro­n­avirus-re­lat­ed drug short­age

Around 10 PM ET last night, the FDA said that it is aware of a drug short­age re­lat­ed to an ac­tive phar­ma­ceu­ti­cal in­gre­di­ent (API) man­u­fac­tur­er af­fect­ed by the coro­n­avirus, but the agency stopped short of re­veal­ing what drug it is.

“The short­age is due to an is­sue with man­u­fac­tur­ing of an ac­tive phar­ma­ceu­ti­cal in­gre­di­ent used in the drug. It is im­por­tant to note that there are oth­er al­ter­na­tives that can be used by pa­tients. We are work­ing with the man­u­fac­tur­er as well as oth­er man­u­fac­tur­ers to mit­i­gate the short­age. We will do every­thing pos­si­ble to mit­i­gate the short­age,” FDA Com­mis­sion­er Stephen Hahn said in a state­ment.

An FDA spokesper­son al­so con­firmed to Fo­cus that the agency can­not dis­close the drug in short­age “as it is con­fi­den­tial com­mer­cial in­for­ma­tion.”

But she al­so ex­plained why the FDA is in a dif­fi­cult po­si­tion with re­spect to such short­ages and keep­ing the pub­lic in­formed.

“While man­u­fac­tur­ers are legal­ly re­quired to re­port drug sup­ply dis­rup­tions to FDA, they are not re­quired to pro­vide the de­tailed in­for­ma­tion on their sup­ply chain that we have need­ed to mon­i­tor the drug sup­ply since the on­set of the out­break,” the spokesper­son said. “We need the co­op­er­a­tion of the drug com­pa­nies in or­der to ob­tain ac­cu­rate in­for­ma­tion as we proac­tive­ly take steps to mit­i­gate drug short­ages, and com­pa­nies will be less will­ing to pro­vide this vol­un­tary in­for­ma­tion if they can­not trust FDA not to dis­close com­mer­cial con­fi­den­tial in­for­ma­tion such as drug names, com­pa­ny names or ex­act lo­ca­tion of fa­cil­i­ties.”

Al­though it may be dif­fi­cult to as­cer­tain which drug is af­fect­ed, re­cent­ly added drug short­ages to FDA’s list in­clude Al­ler­gan’s treat­ment for com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions, Avy­caz (cef­tazidime and avibac­tam), My­lan’s blood pres­sure drug pin­dolol 10mg (and Sun Phar­ma­ceu­ti­cal pro­vides the same drug), and Pfiz­er’s chemother­a­py flu­dara­bine phos­phate for in­jec­tion.

Al­ler­gan told Fo­cus in a state­ment: “We are ex­pe­ri­enc­ing an out of stock sit­u­a­tion for AVY­CAZ (cef­tazidime and avibac­tam) for in­jec­tion (2.5g) as we await reg­u­la­to­ry ap­proval on a new third-par­ty man­u­fac­tur­er, which will ul­ti­mate­ly al­low us to con­tin­ue our sup­ply in the U.S. This sit­u­a­tion is not re­lat­ed to any prod­uct or safe­ty is­sue. All cur­rent­ly avail­able AVY­CAZ sup­ply is un­af­fect­ed and not at risk for re­call…To be clear our re­cent drug short­age of AVY­CAZ is not re­lat­ed to the coro­n­avirus.”

The rea­son­ing be­hind My­lan and Sun’s short­ages is list­ed as “short­age of ac­tive in­gre­di­ent,” and My­lan did not re­spond to a re­quest for com­ment.

And for flu­dara­bine, the FDA list­ing says dis­con­tin­u­a­tion of the man­u­fac­ture of the drug is due to API sup­pli­er mar­ket ex­it. The cur­rent sup­ply is ex­pect­ed to be ex­haust­ed next Au­gust.

A Pfiz­er spokesper­son told Fo­cus the short­age “is com­plete­ly un­re­lat­ed and pre-dates the out­break…The ma­jor­i­ty of our fin­ished prod­uct and ac­tive phar­ma­ceu­ti­cal in­gre­di­ent are sourced from coun­tries oth­er than Chi­na. To date, we have not seen a dis­rup­tion to our sup­ply as a re­sult of the virus.”


RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

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