OIG re­port ac­cus­es FDA of not fol­low­ing poli­cies for for­eign drug in­spec­tions

A new re­port from the US De­part­ment of Health and Hu­man Ser­vices’ Of­fice of In­spec­tor Gen­er­al ac­cus­es the FDA of not fol­low­ing its poli­cies around for­eign drug in­spec­tions, and rec­om­mends some im­prove­ments.

The OIG re­port, re­leased on Thurs­day, found that the FDA has not al­ways fol­lowed its poli­cies and pro­ce­dures for for­eign for-cause drug in­spec­tions, and that the agency al­leged­ly mis­placed doc­u­ments to prove its lead in­ves­ti­ga­tors com­plet­ed their re­quired train­ing.

The OIG al­so ac­cused the agency of fail­ing to record cer­tain in­for­ma­tion such as whether an in­spec­tion was an­nounced, and lack­ing poli­cies re­quir­ing su­per­vi­sors to ver­i­fy that lead in­ves­ti­ga­tors com­plet­ed their train­ing.

The FDA blamed lim­it­ed re­sources and “un­ex­pect­ed events and com­plex cir­cum­stances,” ac­cord­ing to the re­port. Agency of­fi­cials told the OIG that due to mul­ti­ple lo­ca­tion moves, it had mis­placed records show­ing that lead in­ves­ti­ga­tors met the train­ing re­quire­ments.

The re­port notes that the FDA’s over­sight is be­com­ing more com­pli­cat­ed as drugs that used to be man­u­fac­tured in the US are go­ing over­seas. Ac­cord­ing to the OIG,  74 % of API man­u­fac­tur­ers and 54% of fin­ished goods man­u­fac­tur­ers are now lo­cat­ed out­side the US. Though the agency start­ed im­ple­ment­ing some changes to the for­eign in­spec­tion process in 2017, Con­gress has ex­pressed con­cerns.

“We rec­om­mend that FDA iden­ti­fy and im­ple­ment ad­di­tion­al ways to im­prove the time­li­ness of its for­eign for-cause drug in­spec­tion process. We al­so made oth­er pro­ce­dur­al rec­om­men­da­tions that are list­ed in the re­port,” the re­port states.

Ac­cord­ing to the OIG, the FDA agreed with the rec­om­men­da­tions and promised to work on im­prov­ing the time­li­ness of its over­all for­eign in­spec­tion process. The agency al­so said it would im­ple­ment a sys­tem to “bet­ter doc­u­ment and track in­ves­ti­ga­tors’ qual­i­fi­ca­tions and cer­ti­fi­ca­tion.”

“FDA al­so stat­ed that it is ad­dress­ing ways to re­duce the time spent writ­ing and re­view­ing EIRs and that it is con­duct­ing a work­load analy­sis for in­di­vid­u­als re­spon­si­ble for de­ter­min­ing fi­nal clas­si­fi­ca­tion, is­su­ing warn­ing let­ters, and hold­ing reg­u­la­to­ry meet­ings,” the re­port said. How­ev­er, no time­line was giv­en.

For­eign in­spec­tions have al­ways been a ma­jor top­ic for the FDA. For­eign drug fa­cil­i­ty in­spec­tions fell by about 10% from 2016 to 2018 as the FDA strug­gled to hire new in­spec­tors. At the time, Re­pub­li­cans ar­gued that the agency was not com­plet­ing enough for­eign drug in­spec­tions and that it couldn’t hire enough in­spec­tors.

In March, a bill came for­ward that would re­quire FDA to con­duct a pi­lot pro­gram to in­crease the num­ber of unan­nounced in­spec­tions of for­eign drug fa­cil­i­ties, which was a pro­vi­sion al­so in­clud­ed in the fed­er­al bud­get bill. The leg­is­la­tion would al­so is­sue a re­port to eval­u­ate any dif­fer­ences be­tween unan­nounced and an­nounced in­spec­tions, bar­ri­ers to con­duct­ing unan­nounced in­spec­tions, and chal­lenges to evening the play­ing field for do­mes­tic and for­eign drug in­spec­tions.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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European Commissioner for Health Stella Kyriakides (AP Photo/Francisco Seco, Pool)

One fi­nal push: EU phar­ma in­dus­try group de­mands com­pe­ti­tion check on in­com­ing leg­isla­tive over­haul

The Brussels-based European Federation of Pharmaceutical Industries and Associations (EFPIA) this morning called on the European Commission to ensure that it adequately assesses how its re-writing of the 20+-year-old pharma legislation, which is due to be released before the end of the month, damages the competitiveness of the pharma industry.

EFPIA’s opposition to the changes has lingered since the beginning, and its latest estimate is that the rewritten legislation could cost the industry €640 million ($688 million).