Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Sen­ate Fi­nance De­moc­rats took aim at Bio­gen’s pricey new Alzheimer’s drug on Thurs­day, but mem­bers on both sides of the aisle at a sep­a­rate ap­pro­pri­a­tions hear­ing didn’t ques­tion act­ing FDA com­mis­sion­er Janet Wood­cock on the ap­proval.

“I was ap­palled that Bio­gen priced their Alzheimer’s drug ap­proved by the FDA at $56,000 per year — I’m not go­ing to de­bate whether this is ef­fec­tive or not, but it’s dou­ble the house­hold me­di­an in­come for Michi­gan­ders over the age of 65,” Sen. Deb­bie Stabenow (D-MI) said at the fi­nance hear­ing.

Chair Ron Wyden (D-OR), while pledg­ing to re-open his drug pric­ing leg­is­la­tion from the last Con­gress that would al­low for CMS to ne­go­ti­ate drug prices, added, “If on­ly a frac­tion of peo­ple suf­fer­ing from Alzheimer’s were pre­scribed Aduhelm, Medicare Part B spend­ing would dou­ble overnight.”

He al­so not­ed the more than $11,000 in co-in­sur­ance each year for those on the new Alzheimer’s in­fu­sion, adding that “over­whelm­ing­ly, the Amer­i­can pub­lic sup­ports this idea” of fur­ther gov­ern­ment drug price ne­go­ti­a­tions. And he sig­naled that Pres­i­dent Biden’s pick for a new FDA com­mis­sion­er is on the way.

The sen­a­tor’s com­ments fol­low ques­tions from Wall Street an­a­lysts ear­li­er in the week on the steep price tag for ad­u­canum­ab.

Xavier Be­cer­ra

HHS Sec­re­tary Xavier Be­cer­ra of­fered lim­it­ed de­tail on his plan for drug price ne­go­ti­a­tions, but said he re­mained open to sit­ting down and com­ing up with a so­lu­tion.

“The phar­ma­ceu­ti­cal lob­by­ists are out there fear mon­ger­ing, and press­ing us to pass some wa­tered-down bill that fails to tack­le drug prices head on, how do you think Con­gress should re­spond?” Sen. Eliz­a­beth War­ren (D-MA) said, not­ing that it’s part of the pres­i­dent’s agen­da.

Be­cer­ra said he’ll leave it to Con­gress on what to craft, but said he thinks there should be a gen­er­a­tional change on how to do busi­ness when it comes to pre­scrip­tion med­ica­tion.

War­ren called for “all of the pri­or­i­ties,” in­clud­ing au­tho­riz­ing price ne­go­ti­a­tions “with re­al mus­cle,” ex­pand­ing Medicare ben­e­fits, and low­er­ing the Medicare el­i­gi­bil­i­ty age.

Oth­er De­moc­rats sound­ed split on what to do with drug prices.

Sen. Bob Menen­dez (D-NJ), whose dis­trict in­cludes some bio­phar­ma com­pa­nies and is a crit­i­cal vote for De­moc­rats with the 50-50 Sen­ate split, said he’s con­cerned that the gov­ern­ment con­sis­tent­ly takes rev­enue from the in­dus­try but that doesn’t low­er the costs of drugs for con­sumers.

“For me, the bot­tom line is show me how you’re go­ing to low­er the price for con­sumers on pre­scrip­tion drugs,” and in a way that doesn’t stop in­dus­try from pro­duc­ing more life-sav­ing vac­cines, Menen­dez said. Two oth­er Sen­ate De­moc­rats, Tom Carp­er (DE) and Cather­ine Cortez Mas­to (NV), who in­tro­duced price trans­paren­cy leg­is­la­tion last year, sig­naled ear­li­er that they might al­so not be ready for a big drug price ne­go­ti­a­tion bill.

Sen. Ben Cardin (D-MD) al­so raised ques­tions on how HHS is deal­ing with drug short­ages in light of the pan­dem­ic, es­pe­cial­ly when the prof­it mo­tive is non-ex­is­tent.

“We’re try­ing to boost the sup­ply,” Be­cer­ra said, in­clud­ing through the use of more do­mes­tic man­u­fac­tur­ing.

Wood­cock silent on ad­u­canum­ab

In an­oth­er hear­ing on Thurs­day be­fore a Sen­ate Ap­pro­pri­a­tions sub­com­mit­tee, act­ing FDA com­mis­sion­er Janet Wood­cock tes­ti­fied on the FDA’s 2022 bud­get plan but said noth­ing of Mon­day’s ap­proval of Bio­gen’s Aduhelm.

Pa­trizia Cavaz­zoni

None of the sen­a­tors ques­tioned Wood­cock on the ac­cel­er­at­ed ap­proval, and her name has re­mained large­ly out of the spot­light since the ap­proval de­ci­sion was an­nounced by the agency. FDA state­ments all came from CDER di­rec­tor Pa­trizia Cavaz­zoni and OND di­rec­tor Pe­ter Stein, in ad­di­tion to a let­ter from neu­ro­science head Bil­ly Dunn to the ad­vi­so­ry com­mit­tee that vot­ed against its ap­proval.

On­ly Sen. Jer­ry Moran (R-KS), a mem­ber of the Con­gres­sion­al Task Force on Alzheimer’s Dis­ease, men­tioned the ap­proval, and he praised Wood­cock on it.

Mean­while, three mem­bers of the ad­vi­so­ry com­mit­tee that re­viewed ad­u­canum­ab have now re­signed in protest over the ap­proval.

Both sides of the aisle al­so com­mend­ed the FDA for quick­ly of­fer­ing EUAs for the Covid-19 vac­cines from Pfiz­er, Mod­er­na and J&J and en­sur­ing they’re safe and ef­fec­tive.

Wood­cock’s tes­ti­mo­ny high­light­ed her agency’s bud­get plan, which seeks a net bud­get au­thor­i­ty in­crease of $322 mil­lion, the bulk of which would go for in­fra­struc­ture in­vest­ments, and an in­crease of $18.8 mil­lion to ORA’s base fund­ing to sup­port FDA’s in­spec­tions pro­gram.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

As drug­mak­ers spend $6B an­nu­al­ly on DTC ads, sen­a­tors re­vive bill to in­clude list prices in ads

A new GAO report on biopharma companies’ $6 billion annual spending on direct-to-consumer advertising is pushing US Senate Majority Whip Dick Durbin (D-IL) and Sen. Chuck Grassley (R-IA) to reintroduce legislation that would require price disclosures in the ads.

The GAO found that drugmakers spent almost half—$8.2 billion of the $17.8 billion from 2016 to 2018—on DTC ads for drugs in three therapeutic categories, including inflammatory conditions (e.g., arthritis, gout), endocrine and metabolic disorders (e.g., type 2 diabetes, hypothyroidism), and conditions affecting the central nervous system (e.g., depression, multiple sclerosis), according to the new report.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.