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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,900+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,900+ biopharma pros reading Endpoints daily — and it's free.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,900+ biopharma pros reading Endpoints daily — and it's free.

Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,900+ biopharma pros reading Endpoints daily — and it's free.

George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,900+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Re­call re­port: Nos­trum re­calls an­oth­er lot of met­formin as car­cino­gen con­cerns con­tin­ue

For the second time in January and the third time in the last two months, a Kansas City, MO laboratory has pulled a lot of generic metformin from the shelves after it was found to contain higher-than-allowed levels of a probable human carcinogen.

The FDA on Tuesday announced that Nostrum Laboratories was voluntarily recalling a lot of metformin HCl extended release tablets, USP 750 mg, a type 2 diabetes drug (the generic equivalent to Glucophage tablets) after testing discovered elevated levels of nitrosamine, the probable carcinogen.