FDA au­tho­rizes sale of e-cig­a­rettes for the first time, shift­ing de­bate and draw­ing fire from crit­ics

For the first time, the FDA on Tues­day au­tho­rized to­bac­co com­pa­nies to mar­ket elec­tron­ic cig­a­rettes.

Reg­u­la­tors au­tho­rized three prod­ucts in a sim­i­lar fash­ion as they would with phar­ma­ceu­ti­cals, al­though this time it was for long­time to­bac­co com­pa­ny RJ Reynolds.

The au­tho­riza­tions were for a va­p­ing de­vice and as­so­ci­at­ed to­bac­co-fla­vored pods, with FDA say­ing the ben­e­fits in wean­ing long­time smok­ers off tra­di­tion­al cig­a­rettes out­weighed the risks of get­ting younger peo­ple ad­dict­ed. The agency em­pha­sized it is on­ly au­tho­riz­ing prod­ucts that taste like to­bac­co, rather than fla­vored pods more ap­peal­ing to kids and teenagers, such as can­dy, mint and fruit.

Nonethe­less, the move will like­ly shift pub­lic de­bate about e-cig­a­rettes and is al­ready draw­ing crit­i­cism from an­ti-smok­ing ad­vo­cates, the New York Times and oth­ers re­port­ed.

Ra­ja Kr­ish­namoor­thi

En­er­gy & Com­merce com­mit­tee chair Frank Pal­lone (D-NJ) said in a state­ment, “While I am pleased that FDA de­nied re­quests by the man­u­fac­tur­er to mar­ket cer­tain fla­vors, I re­main con­cerned giv­en this prod­uct’s pop­u­lar­i­ty with youth.”

“FDA has turned its back on the pub­lic health by ap­prov­ing a high-nico­tine e-cig­a­rette,” Rep. Ra­ja Kr­ish­namoor­thi (D-IL) said in a state­ment, adding, “FDA has ig­nored the da­ta and missed an­oth­er op­por­tu­ni­ty to ad­dress the youth va­p­ing epi­dem­ic.”

In ex­plain­ing its rea­sons for the au­tho­riza­tion, the FDA ap­peared to ap­proach its de­ci­sion sim­i­lar to how it con­sid­ers ex­per­i­men­tal drugs. The agency stud­ied how e-cig­a­rettes have helped smok­ers who ful­ly switched to the elec­tron­ic prod­ucts, re­duc­ing ex­po­sure to harm­ful car­cino­gens.

FDA then weighed that ben­e­fit against the risk of youth be­com­ing more ad­dict­ed to va­p­ing prod­ucts. Reg­u­la­tors said they con­duct­ed stud­ies say­ing to­bac­co-fla­vored prod­ucts were among the least pre­ferred by young e-cig­a­rette users, and not­ed RJ Reynolds will have to com­plete post-mar­ket­ing re­quire­ments to en­sure the au­tho­riza­tion does not get re­voked.

The Vuse prod­ucts will al­so be for­bid­den from be­ing mar­ket­ed as safe or “FDA ap­proved,” the agency said. In the same an­nounce­ment, FDA placed strict lim­i­ta­tions on dig­i­tal, ra­dio and tele­vi­sion ad­ver­tis­ing, as well as deny­ing au­tho­riza­tion to 10 fla­vored Vuse car­tridges.

E-cig­a­rettes first emerged in the ear­ly-to-mid-2000s, aimed at at­tract­ing long­time smok­ers to switch to a less harm­ful prod­uct while avoid­ing the with­draw­al symp­toms typ­i­cal­ly ac­com­pa­ny­ing stop­ping tra­di­tion­al cig­a­rette use. But fla­vored prod­ucts soon ap­peared on the mar­ket, no­tably in brands like Ju­ul and Vuse, and use among teenagers be­gan to sky­rock­et.

Va­p­ing has long been un­reg­u­lat­ed but the FDA has been mov­ing to crack down in re­cent years. This past Au­gust, reg­u­la­tors or­dered sev­er­al e-cig­a­rette and pod man­u­fac­tur­ers to pull more than 55,000 fla­vors or planned fla­vors from the mar­ket or risk en­force­ment, say­ing they failed to pro­vide enough ev­i­dence the prod­ucts pro­vid­ed a pub­lic health ben­e­fit.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty


I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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