New study looks at FDA's use of so­cial me­dia to com­mu­ni­cate on drug safe­ty

A new study look­ing at the FDA use of so­cial me­dia to com­mu­ni­cate about drug safe­ty finds that the agency could im­prove its im­pact by de­vel­op­ing so­cial me­dia strate­gies and tak­ing a more ac­tive role on web plat­forms.

The study, con­duct­ed by re­searchers at Har­vard Med­ical School, North­east­ern Uni­ver­si­ty, Boston Chil­dren’s Hos­pi­tal and The Ohio State Uni­ver­si­ty, and fund­ed by FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search, looks specif­i­cal­ly at FDA’s use of so­cial me­dia fol­low­ing two drug safe­ty com­mu­ni­ca­tions (DSCs) for drugs con­tain­ing zolpi­dem, the ac­tive in­gre­di­ent in Am­bi­en.

In 2013, FDA is­sued two DSCs re­lat­ed to zolpi­dem, the first in Jan­u­ary warn­ing of the risk of next-day im­pair­ment af­ter tak­ing in­som­nia drugs and re­quir­ing low­er rec­om­mend­ed dos­es for drugs con­tain­ing zolpi­dem, and the sec­ond no­ti­fy­ing the pub­lic that the agency had ap­proved those la­bel­ing changes.

In ad­di­tion to pub­lish­ing the DSCs to its web­site, FDA made posts re­lat­ed to the DSCs on its var­i­ous so­cial me­dia ac­counts, in­clud­ing its Face­book page and three of its Twit­ter ac­counts (@US_FDA@FDA_Drug_In­fo and @FDAMed­Watch).

For the first DSC, FDA post­ed once to its Face­book ac­count, get­ting 61 shares, and tweet­ed six times across its three ac­counts, for a to­tal of 111 retweets.

To mea­sure the im­pact of FDA’s posts, the au­thors iden­ti­fied some 174,000 tweets and 59,000 Face­book posts ref­er­enc­ing zolpi­dem be­tween 1 Oc­to­ber 2012 and 31 Au­gust 2013. Of those, rough­ly 9% of the tweets were tagged as ad­verse events (AEs), 74% were tagged as men­tions and 17% were con­sid­ered junk. For the Face­book posts, 5% were iden­ti­fied as AEs, 69% as men­tions and 26% as junk.

How­ev­er, for the sec­ond DSC, FDA did not post to Face­book and on­ly tweet­ed about the DSC for its@FDA_Drug_In­fo ac­count (3 tweets, 37 retweets), though the agency al­so tweet­ed gen­er­al­ly about a group of re­cent pre­scrib­ing changes, in­clud­ing for zolpi­dem, from its@FDAMed­Watch ac­count.

The au­thors ob­served a greater so­cial me­dia re­sponse from both Twit­ter and Face­book users fol­low­ing the first DSC, but did not no­tice an in­crease in so­cial ac­tiv­i­ty re­lat­ed to zolpi­dem fol­low­ing the sec­ond com­mu­ni­ca­tion.

The au­thors say that the dif­fer­ence in so­cial me­dia re­sponse to the two safe­ty com­mu­ni­ca­tions can be ex­plained by the dif­fer­ence in how FDA is­sued the com­mu­ni­ca­tions. In ad­di­tion to post­ing about the first DSC more fre­quent­ly and to more of its ac­counts, the first DSC was al­so is­sued with an ac­com­pa­ny­ing press re­lease.

Rec­om­men­da­tions

To make bet­ter use of its so­cial me­dia pres­ence in the fu­ture, the au­thors rec­om­mend that FDA de­vel­op strate­gies for how and how of­ten to post dif­fer­ent types of mes­sages.

“Since there can be a lot of ques­tion­able in­for­ma­tion shared on so­cial me­dia, the FDA should be able to lever­age its in­de­pen­dent ex­per­tise and po­si­tion as a wide­ly trust­ed source of in­for­ma­tion to help pro­mote ac­cu­rate and in­for­ma­tive mes­sages. In the case of the zolpi­dem safe­ty alerts, the FDA took some steps to do that, but could cre­ate more out­reach and dis­sem­i­nate its ma­te­ri­als more fre­quent­ly via var­ied plat­forms,” Michael Sin­ha, a post­doc­tor­al fel­low at Har­vard and lead au­thor on the pa­per told Fo­cus.

Sin­ha al­so em­pha­sized that the so­cial me­dia land­scape is sub­stan­tial­ly dif­fer­ent now than in 2013 when these safe­ty com­mu­ni­ca­tions were is­sued.

“So­cial me­dia like Twit­ter was seen as more of a recre­ation­al tool in 2013, but now many pro­fes­sion­als, aca­d­e­m­ic in­sti­tu­tions and com­pa­nies have vi­brant so­cial me­dia pres­ences. In­creased health pro­fes­sion­al en­gage­ment on so­cial me­dia in­creas­es the like­li­hood that FDA con­tent on these plat­forms would be more wide­ly dis­sem­i­nat­ed and have a greater im­pact,” he said.

The pa­per al­so rec­om­mends that FDA de­vel­op a greater un­der­stand­ing of so­cial me­dia plat­form fea­tures and user pref­er­ences to de­vel­op its ap­proach to post­ing.

“FDA should try to stay on top of the ever-evolv­ing strate­gies be­ing de­vel­oped on so­cial me­dia to am­pli­fy mes­sages—such as use of han­dles or hash­tags on Twit­ter—that can bring at­ten­tion to im­por­tant drug safe­ty con­tent dis­sem­i­nat­ed by the agency,” Sin­ha said.

The au­thors al­so sug­gest that FDA should take mat­ters in­to its own hands when it comes to up­dat­ing in­for­ma­tion about drugs on Wikipedia.

De­spite mul­ti­ple ed­its to the Wikipedia page cor­re­spond­ing to both com­mu­ni­ca­tions, the pages con­tained in­com­plete in­for­ma­tion and did not cite the DSCs them­selves.

“Giv­en that in­for­ma­tion­al sites like Wikipedia are com­mon­ly ac­cessed by the lay pub­lic for in­for­ma­tion on drugs and that any­one can ed­it the con­tent, the FDA should con­sid­er a plan to for­mal­ly up­date the pages for ap­pro­pri­ate con­tent at the time a DSC is re­leased and to en­sure con­tin­ued ac­cu­ra­cy of the in­for­ma­tion over time,” the au­thors write.


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

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The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

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Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

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Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

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Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.