Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Phar­ma in the crosshairs: How the FTC is ex­pand­ing its an­titrust pow­ers un­der its new chair

Less than a month since her Sen­ate con­fir­ma­tion, the new, young and staunch­ly pro­gres­sive Fed­er­al Trade Com­mis­sion chair Lina Khan is ready to up the pres­sure on un­fair busi­ness prac­tices, in­clud­ing at the largest phar­ma com­pa­nies. To do that, Khan is rolling back re­stric­tions on an­titrust in­ves­ti­ga­tions and po­ten­tial­ly open­ing the flood gates on Big Phar­ma M&A.

On Thurs­day, Khan led a vote to ap­prove a se­ries of res­o­lu­tions that di­rect agency staff to ramp up its in­ves­ti­ga­tions, via sub­poe­nas or oth­er­wise, around sev­en spe­cif­ic en­force­ment pri­or­i­ties, in­clud­ing phar­ma com­pa­nies, PBMs, and hos­pi­tals. While the com­mis­sion has his­tor­i­cal­ly re­quired its an­titrust staff to ob­tain the full com­mis­sion’s ap­proval to be­gin such in­ves­ti­ga­tions, the FTC will now be able to open in­ves­ti­ga­tions or is­sue sub­poe­nas with on­ly one com­mis­sion­er’s ap­proval, and that in­cludes in­ves­ti­ga­tions in­to phar­ma com­pa­nies.

“These tar­get­ed res­o­lu­tions would stream­line in­ves­ti­ga­tions that fall with­in these sub­ject ar­eas, en­abling more ex­pe­di­tious in­ves­ti­ga­to­ry process. This is par­tic­u­lar­ly im­por­tant giv­en that we are in the midst of a mas­sive merg­er boom,” Khan said in re­marks at one of the first pub­lic meet­ings for FTC’s com­mis­sion­ers in decades. The FTC in March set up an in­ter­na­tion­al work­ing group to more close­ly eval­u­ate phar­ma com­pa­ny merg­ers in light of con­cerns around drug pric­ing and an­ti­com­pet­i­tive be­hav­ior.

Khan al­so led the with­draw­al of a pri­or state­ment from the FTC from 2015, which she said will recom­mit the com­mis­sion to its man­date to po­lice un­fair meth­ods of com­pe­ti­tion even if they are out­side the am­bit of two an­titrust laws, known as the Sher­man or Clay­ton Acts. The FTC’s two Re­pub­li­cans op­posed all of the mea­sures passed on Thurs­day, and Khan’s po­si­tion­ing shows how the FTC will be a more par­ti­san agency than in the past. Ama­zon has al­ready sought to re­cuse Khan from an­titrust in­ves­ti­ga­tions be­cause of her past com­ments on the on­line re­tail gi­ant.

Ro­hit Chopra

One of the three De­mo­c­ra­t­ic com­mis­sion­ers, Ro­hit Chopra, is still await­ing Sen­ate con­fir­ma­tion to head the Con­sumer Fi­nan­cial Pro­tec­tion Bu­reau thanks to a Biden nom­i­na­tion, but his de­par­ture and the FTC’s even par­ti­san split that’s com­ing (be­fore Biden nom­i­nates an­oth­er FTC com­mis­sion­er) will not ham­per any in­ves­ti­ga­tions that De­moc­rats want to open as a change made Thurs­day will mean Re­pub­li­can com­mis­sion­ers won’t be able to block such in­ves­ti­ga­tions.

And while Khan, just 32 years old, push­es ahead with the strength­en­ing of FTC’s abil­i­ty to go af­ter bad ac­tors, in­clud­ing with a rule­mak­ing fix on Thurs­day, a re­cent Supreme Court de­ci­sion ham­strung the com­mis­sion’s abil­i­ty to se­cure bil­lions of dol­lars in re­lief for con­sumers in a wide va­ri­ety of cas­es, leav­ing the door open for bio­phar­ma com­pa­nies to quick­ly end cer­tain cas­es in­volv­ing an­ti­com­pet­i­tive prac­tices.

“While rule­mak­ing is no sub­sti­tute for a per­ma­nent fix to our Sec­tion 13(b) au­thor­i­ty to ob­tain mon­e­tary re­lief, trade rules can help en­sure that busi­ness­es will no longer be able to take ad­van­tage of con­sumers and ce­ment their mar­ket po­si­tion by en­gag­ing in prac­tices that do peo­ple re­al harm un­til we catch them and take them to court the first time,” De­mo­c­ra­t­ic com­mis­sion­er Re­bec­ca Kel­ly Slaugh­ter wrote in a re­lat­ed state­ment.

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.

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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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.”

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

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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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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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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