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. 

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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Christian Itin, Autolus CEO (Autolus)

#ES­MO20: Au­to­lus pro­vides glimpse of next-gen­er­a­tion CAR-T pro­gram, show­ing ear­ly pos­i­tive safe­ty da­ta

CAR-T therapies were hailed as a breakthrough when Novartis received the first FDA approval for Kymriah back in 2017. Though highly effective at treating certain types of blood cancers, CAR-Ts are also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome.

With this in mind, Autolus Therapeutics is looking to take a crack at a safer CAR-T and presented Phase II cohort data for its AUTO3 program at virtual ESMO 2020. The data showed that, among the 35 patients in the cohort being treated for r/r diffuse large B cell lymphoma, there were no instances of Grade 3 or higher CRS. Eight individuals saw Grade 1 inflammation while another four patients reached Grade 2.

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Sean Bo­hen's break from bio­phar­ma is over. The ex-As­traZeneca CMO has re­tired his Big Phar­ma jer­sey and is now — hap­pi­ly — run­ning a lit­tle biotech

The last I had heard about Sean Bohen, he had stepped out of his high-profile job as chief medical officer at AstraZeneca at the beginning of 2019 as CEO Pascal Soriot triggered a broad-ranging R&D shakeup. And then, earlier this week, I got a chance to catch up.

It turns out that Bohen decided at the time that he would not just jump into a new job in the booming biopharma business. As an oncologist, he had worked on the big programs at AstraZeneca, and before that he was at Genentech. That was good for a ticket to just about anyplace in the big biopharma world. But he felt it was time to stop and think things through.

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Covid-19 roundup: UP­DAT­ED: Amid calls for trans­paren­cy, Mod­er­na re­leas­es full PhI­II pro­to­col; As­traZeneca tri­al halt thought to be 'con­firmed trans­verse myelitis,' per CNN

Prominent scientists, public health experts and industry critics have been calling for more transparency from vaccine makers, including the release of the companies’ Phase III trial protocols. On Thursday, Moderna became the first major developer to do so.

“It is usually not what industry does,” CEO Stéphane Bancel told Endpoints News in an interview in advance of their R&D day today. “But given the need there is for the scientific community and the medical community and the media to understand how the vaccine is being developed, to make sure people are confident in the safety of the process, in the governance with scientific independence in the medical world and the like, we’re dropping tomorrow the full protocol. It is unredacted.”

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