A pharmacist at Whalen's Drug Store, 55 E 42nd Street, is shown putting up a sign advertising the fact that they now have the wonder drug, penicillin, in stock. However, New Yorkers soon learned that the potent germ killer cannot be bought across the counter like liver pills but only by prescription and that it must be administered by a physician. (March 1945 — via Getty Images)

FDA sur­vey finds Amer­i­cans don’t re­al­ly un­der­stand drug ap­provals

On­ly 25% of Amer­i­cans un­der­stand that a new drug ap­proved by the FDA does not nec­es­sar­i­ly mean the drug will help most peo­ple who use it, ac­cord­ing to the re­sults of a sur­vey con­duct­ed in 2017 and pub­lished last week in Phar­ma­coepi­demi­ol­o­gy & Drug Safe­ty.

How­ev­er, FDA’s sur­vey of a na­tion­al­ly rep­re­sen­ta­tive group of 1,744 US adults did find that more than half un­der­stood that the reg­u­la­tor ap­proves pre­scrip­tion drugs when the drug of­fers ben­e­fits that out­weigh the risks, al­though 17.5% thought that an FDA-ap­proved drug will cure the con­di­tion for which it’s pre­scribed.

“Fur­ther in­ves­ti­ga­tion in­to pub­lic knowl­edge of FDA’s OTC [over-the-counter] drug and di­etary sup­ple­ment ap­proval over­sight yield­ed ad­di­tion­al ev­i­dence of a lack of un­der­stand­ing re­lat­ed to the ap­proval of such prod­ucts. We found that 69.3% of re­spon­dents thought that FDA ap­proves all over‐the‐ counter drugs. One quar­ter of re­spon­dents (24.9%) be­lieved FDA ap­proves di­etary sup­ple­ments and an­oth­er quar­ter (24.5%) did not know,” the sur­vey’s au­thors found.

In ad­di­tion to the find­ings on the ap­provals, the re­searchers al­so sought to un­der­stand how the pub­lic views FDA’s role in reg­u­lat­ing di­rect-to-con­sumer (DTC) pre­scrip­tion drug ad­ver­tis­ing.

FDA re­searchers found less of an un­der­stand­ing with DTC ads, not­ing that 31% in­cor­rect­ly thought that FDA ap­proves DTC ad­ver­tis­ing, and less than half in­cor­rect­ly thought that risk or ben­e­fit state­ments in ads are FDA‐ap­proved.

Al­though the re­searchers said the sur­vey aligns with pre­vi­ous sur­veys, they al­so said it sug­gests “that some of the mis­con­cep­tions held by con­sumers may have a neg­a­tive im­pact on pub­lic health. For in­stance, we found that 42.9% of con­sumers were not able to ac­cu­rate­ly re­port that FDA‐ap­proved pre­scrip­tion drugs may cause harm. This is con­cern­ing be­cause some ad­verse events re­quire dis­con­tin­u­a­tion or dose mod­i­fi­ca­tion. More­over, ad­verse event re­port­ing is crit­i­cal to phar­ma­covig­i­lance and un­der‐re­port­ing of ad­verse events is a con­sis­tent prob­lem world­wide.”

They al­so ex­plained how there is an op­por­tu­ni­ty to en­hance con­sumers’ un­der­stand­ing of drug ap­provals, FDA’s role and over­sight of pre­scrip­tion drug ad­ver­tise­ments.

As far as po­ten­tial ways to im­prove the pub­lic’s un­der­stand­ing on drug ap­provals, one of the sug­ges­tions is to place ban­ner ads on gen­er­al health ref­er­ence web­sites, like Drugs.com, Web­MD.com and may­oclin­ic.org, with short mes­sages of­fer­ing key facts about the ap­proval process and reg­u­la­tion of ad­ver­tise­ments.


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. 

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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