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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Alarmed by side ef­fect, FDA slaps clin­i­cal hold on Sarep­ta's next-gen Duchenne drug

Sarepta Therapeutics’ next-gen Duchenne muscular dystrophy drug has been hit with a clinical hold after investigators flagged a serious case of low magnesium levels in one patient’s blood.

Screening and dosing will be halted in what is known as Part B of the Phase II MOMENTUM study, which has enrolled about half of the planned patients. Sarepta said it will be submitting information on all cases of the condition, known as hypomagnesemia, per the FDA’s request and proposing some changes to the risk mitigation and safety monitoring plan.

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When will the FDA re­scind a break­through des­ig­na­tion? New draft guid­ance spells out the com­pli­cat­ed de­tails

Although it’s exceedingly rare for the FDA to rescind a breakthrough designation once it’s granted, there has been a recent uptick — as in 2020 and 2021 combined, the agency rescinded 17 BTDs, compared to just 18 rescinded from 2015 to 2019 combined.

Protagonist Therapeutics saw this reality up close and personal in April after a clinical hold lifted on its experimental blood cancer drug, as the company revealed that the FDA sought to revoke the BTD. The decision, Protagonist says, stems from “observed malignancies” related to the hold, initially imposed in September 2021.

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