'Re­call ready': FDA urges com­pa­nies to com­ply with drug re­call guid­ance

The FDA has fi­nal­ized guid­ance to help com­pa­nies quick­ly re­call prod­ucts and take the nec­es­sary steps be­fore a prod­uct reach­es the re­call stage, as part of work pull vi­ola­tive prod­ucts and keep them out of the hands of con­sumers.

Ini­ti­a­tion of Vol­un­tary Re­calls of­fers guid­ance for com­pa­nies to de­vel­op pro­ce­dures in­clud­ing train­ing, plan­ning and record-keep­ing to re­duce the time a dan­ger­ous prod­uct is on the mar­ket and lim­it the risk of ex­po­sure. The FDA can re­call con­trolled sub­stances, bi­o­log­i­cal prod­ucts, hu­man cells, tis­sues and cel­lu­lar and tis­sue-based prod­ucts, as well as med­ical de­vices and food.

The re­port al­so ex­plains how to keep records and prod­uct cod­ing. Since re­calls af­fect the en­tire sup­ply chain, the FDA says that a pro­ce­dure should be in place to quick­ly in­form every­one in line, from down­stream sup­pli­ers to whole­salers and ven­dors. The fi­nal guid­ance builds off of a draft from April 2019.

“Vol­un­tary re­calls con­tin­ue to be the fastest, most ef­fec­tive way for a com­pa­ny to cor­rect or re­move vi­ola­tive and po­ten­tial­ly harm­ful prod­ucts from the mar­ket to help keep con­sumers safe,” said Ju­dith McMeekin, the FDA’s as­so­ciate com­mis­sion­er of reg­u­la­to­ry af­fairs. “It is crit­i­cal that all com­pa­nies in the sup­ply chain are ‘re­call ready’ to en­sure ap­pro­pri­ate ac­tions are tak­en swift­ly across the dis­tri­b­u­tion chan­nels to best pro­tect pub­lic health and the in­tegri­ty of the sup­ply chain. We will con­tin­ue to work with com­pa­nies to im­prove their re­call pro­ce­dures and min­i­mize Amer­i­cans’ ex­po­sure to po­ten­tial­ly harm­ful prod­ucts.”

There have been 14 drugs re­called since the start of 2022 alone, ac­cord­ing to the FDA’s web­site. Most re­cent­ly, Braun Med­ical was forced to vol­un­tar­i­ly re­call five lots of its 0.9% Sodi­um Chlo­ride for In­jec­tion USP 250ML due to flu­id leak­age or low fill vol­ume. That re­call was an­nounced Thurs­day.

In 2021, there were 77 drugs re­called. Most no­tably was the in­dus­try’s is­sues with ND­MA con­t­a­m­i­na­tion, a known prob­a­ble hu­man car­cino­gen with can­cer-caus­ing po­ten­tial.

In Jan­u­ary, Viona Phar­ma­ceu­ti­cals re­called 33 lots of met­formin hy­drochlo­ride af­ter find­ing traces of ND­MA. But Pfiz­er bat­tled is­sues with the con­t­a­m­i­na­tion of its an­ti-smok­ing drug Chan­tix in June, Ju­ly, Au­gust and Sep­tem­ber for ND­MA. Lots were dis­trib­uted in the US, US Vir­gin Is­lands and Puer­to Ri­co from May 2019 to Sep­tem­ber 2021. In 2018, blood pres­sure drug val­sar­tan was pulled for the same rea­son. Last Jan­u­ary, Nos­trum Lab­o­ra­to­ries twice vol­un­tar­i­ly re­called its gener­ic met­formin. In No­vem­ber 2020, a batch of 500 mg tablets was re­called for the same rea­son.

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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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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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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FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

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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