Study: Just half of post­mar­ket­ing com­mit­ment tri­als are pub­lished

A new study pub­lished Mon­day in BMC Med­i­cine finds that on­ly about half of the clin­i­cal tri­als re­quest­ed by the FDA as part of post­mar­ket­ing com­mit­ments for new­ly ap­proved drugs and bi­o­log­ics are pub­lished in peer-re­viewed jour­nals.

The study al­so found that in­for­ma­tion for near­ly half of the post­mar­ket­ing com­mit­ment stud­ies sub­ject to re­port­ing re­quire­ments un­der sec­tion 506B of Fed­er­al Food, Drug, and Cos­met­ic Act (FD­CA) was not up to date.

Con­duct­ed by re­searchers at Yale Uni­ver­si­ty, Uni­ver­si­ty of Con­necti­cut and Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co, the study re­viewed post­mar­ket­ing com­mit­ments for the 110 new drugs and bi­o­log­ics ap­proved from 2009-2012.

Un­like post­mar­ket­ing re­quire­ments, which drug­mak­ers must con­duct as a con­di­tion of ap­proval, post­mar­ket­ing com­mit­ments are agreed to by drug­mak­ers at the time of ap­proval and are not re­quired un­der statute or reg­u­la­tion.

More than half (55.5%) of the 110 ap­provals had one or more post­mar­ket­ing com­mit­ment(s), with 33 re­quir­ing a new clin­i­cal tri­al. Of those, 27 were sub­ject to Sec­tion 506B re­port­ing re­quire­ments.

For the stud­ies sub­ject to re­port­ing re­quire­ments, 12 (44.4%) were nei­ther closed nor had an up-to-date sta­tus in pub­licly avail­able data­bas­es on the FDA’s web­site.

The study did find, how­ev­er, that near­ly all the clin­i­cal tri­als re­quest­ed as part of post­mar­ket­ing com­mit­ments were reg­is­tered on Clin­i­cal­Tri­ (90.3%), most of which were marked as com­plet­ed or ter­mi­nat­ed (82.1%). Of the com­plet­ed or ter­mi­nat­ed stud­ies all but one had re­port­ed re­sults.

How­ev­er, the au­thors found that most of the stud­ies (81.8%) that had re­port­ed re­sults on Clin­i­cal­Tri­ re­port­ed their re­sults af­ter the sched­uled sub­mis­sion dead­line.

On­ly about half of the stud­ies that were el­i­gi­ble for pub­li­ca­tion (i.e. com­plet­ed or ter­mi­nat­ed in Clin­i­cal­Tri­ or sub­mit­ted, ful­filled or re­leased ac­cord­ing to the FDA) were pub­lished in peer-re­viewed jour­nals.

“Among the 29 reg­is­tered or un­reg­is­tered stud­ies for which pub­li­ca­tion would be ex­pect­ed based on the most re­cent sta­tus pro­vid­ed by the FDA, phar­ma­ceu­ti­cal com­pa­nies, or on Clin­i­cal­Tri­, just un­der half were pub­lished in a peer-re­viewed jour­nal (14 of 29 (48.3%)),” the au­thors write.

And while post­mar­ket­ing com­mit­ments on­ly make up 19% of the postap­proval com­mit­ments and re­quire­ments im­posed by the FDA, the au­thors say the da­ta gen­er­at­ed by post­mar­ket­ing com­mit­ments “may be a po­ten­tial­ly im­por­tant source of in­for­ma­tion about drug and bi­o­log­ic safe­ty and ef­fec­tive­ness af­ter mar­ket ap­proval.”


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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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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Carole Ben-Maimon, CEO of Larimar Therapeutics

Lari­mar to re­spond to FDA this quar­ter on 15-month clin­i­cal hold of PhI Friedre­ich's atax­ia drug

More than a year after the FDA clamped down on Larimar Therapeutics with a clinical hold on its lead drug, the biotech thinks it has a way to get that lifted — and an answer could come next quarter if all goes to plan.

Amid a 15-month setback, the biotech plans on filing a complete response to the FDA’s concerns over its drug, CTI-1601, sometime this quarter, which is supposed to elicit an answer from the agency within 30 days, per the regulator.

House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.