President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as phar­ma warns of sup­ply chain dis­rup­tion

Pres­i­dent Don­ald Trump has signed an ex­ec­u­tive or­der de­tail­ing how the fed­er­al gov­ern­ment should help on-shore drug man­u­fac­tur­ing — and the FDA will play a cen­tral role.

The agency now has three months to draw up the list of “es­sen­tial med­i­cines, med­ical coun­ter­mea­sures, and their crit­i­cal in­puts” that the US must have avail­able at all times. Var­i­ous de­part­ments and agen­cies are then di­rect­ed to buy these drugs and their in­gre­di­ents from Amer­i­can man­u­fac­tur­ers.

While lim­it­ed to fed­er­al con­tracts and not pri­vate ones, the ex­ec­u­tive or­der threat­ens to dis­rupt the glob­al sup­ply chain, phar­ma groups warn.

“The ad­min­is­tra­tion is forc­ing bio­phar­ma­ceu­ti­cal com­pa­nies to shift their crit­i­cal at­ten­tion and re­sources away from COVID-19 work to fo­cus on mak­ing sub­stan­tial changes to their busi­ness mod­els nec­es­sary to com­ply with this and oth­er re­cent ex­ec­u­tive or­ders,” PhRMA said in a state­ment. “In­creas­ing U.S. man­u­fac­tur­ing of med­i­cines is a laud­able goal, but it can­not hap­pen overnight and should not come at the ex­pense of in­no­va­tion or Amer­i­cans’ ac­cess to the med­i­cines they need.”

Gil Roth, pres­i­dent of the Phar­ma & Bio­phar­ma Out­sourc­ing As­so­ci­a­tion, said it’s un­clear how ben­e­fi­cial or detri­men­tal the or­der will be to the CD­MOs he rep­re­sents. The sec­tor is strong, he not­ed, and too many ques­tions re­main as to whether new poli­cies will tru­ly ad­dress the bot­tle­becks faced by the in­dus­try.

“Our mem­bers, both on the API and dosage form sides, want a lev­el play­ing field, not a com­mand econ­o­my, and we hope the fed­er­al gov­ern­ment will take in­to ac­count this sec­tor’s ex­ist­ing do­mes­tic ca­pac­i­ty for in­no­v­a­tive and gener­ic drugs be­fore im­ple­ment­ing more man­dates and fund­ing new ca­pac­i­ty at tax­pay­ers’ ex­pense,” he wrote in a state­ment.

Ex­perts have es­ti­mat­ed that as much 90% of the ac­tive phar­ma­ceu­ti­cal in­gre­di­ents in gener­ic drugs sold on US soil is made abroad, al­though there are no of­fi­cial fig­ures.

Un­der the new White House di­rec­tive, gov­ern­ment agen­cies will have to start sub­mit­ting an­nu­al re­ports of where they source their prod­ucts. De­spite the sweep­ing “Buy Amer­i­can” head­line, waivers ap­ply in spe­cif­ic cas­es: when it’s against the pub­lic in­ter­est, the drugs are not pro­duced in the US at a large enough scale, the do­mes­tic prod­ucts would in­crease the cost by more than 25%, or there’s a na­tion­al emer­gency.

Stephen Hahn

FDA com­mis­sion­er Stephen Hahn has sev­er­al more tasks on his list.

Work­ing with HHS Sec­re­tary Alex Azar, he’s charged with ac­cel­er­at­ing FDA ap­proval for do­mes­tic pro­duc­ers of es­sen­tial meds, “in­clud­ing those need­ed for in­fec­tious dis­ease and CBRN threat pre­pared­ness and re­sponse.” In ad­di­tion, he’s al­so ex­pect­ed to is­sue guid­ances for de­vel­op­ing ad­vanced man­u­fac­tur­ing tech­niques, con­duct more site in­spec­tions over­seas and refuse drugs from non-com­pli­ant fa­cil­i­ties.

It re­mains to be seen how the new on-shoring ini­tia­tive will af­fect drug prices, an­oth­er key is­sue Trump is cam­paign­ing on.

For its part, the White House in­sists that low­er­ing the reg­u­la­to­ry bar­ri­er to do­mes­tic phar­ma­ceu­ti­cal man­u­fac­tur­ing (and per­haps rais­ing the bar for for­eign play­ers) and in­vest­ing in new tech would keep drug prices low.

But John and Lau­ra Arnold, who have backed a non-prof­it gener­ic drug man­u­fac­tur­er, are adopt­ing a wait-and-see stance.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Med­ic­aid com­mis­sion to Con­gress: In­crease re­bates for ac­cel­er­at­ed ap­proval drugs

As the FDA continues to approve more new drugs under its accelerated approval pathway, the non-partisan Medicaid and CHIP Payment and Access Commission (MACPAC) is telling Congress to increase the statutory Medicaid rebates for such drugs until their clinical benefits have been verified.

Higher rebates for drugs with accelerated approvals, a move opposed by the biopharma industry, would mean lower net prices, lessening their financial burden on the health care system while incentivizing the companies to speed the verification of the drugs’ clinical benefits in confirmatory trials. Once those benefits are confirmed, the companies would return to the lower rebates when the accelerated approval is converted into a full approval, MACPAC suggests.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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