Janet Woodcock (AP Images)

Why the Biden ad­min­is­tra­tion might not want to be con­tent with just an act­ing FDA com­mis­sion­er

An­oth­er month has passed with­out Pres­i­dent Joe Biden nom­i­nat­ing any­one to fill the per­ma­nent FDA com­mis­sion­er po­si­tion, and ex­perts are con­tin­u­ing to raise con­cerns about what it means for the agency to not have a Sen­ate-ap­proved leader dur­ing a once-in-a-life­time pan­dem­ic.

Joshua Sharf­stein

The push to fill the top spot at the FDA once seemed like a two-per­son race be­tween act­ing com­mis­sion­er Janet Wood­cock, an in­dus­try and FDA in­sid­er fa­vorite who has ruf­fled some feath­ers among Sen­ate De­moc­rats, and for­mer prin­ci­pal deputy com­mis­sion­er of FDA Josh Sharf­stein, who’s now a vice dean and pro­fes­sor at Johns Hop­kins.

Sharf­stein de­clined to com­ment on whether he’s still in­ter­est­ed or up for the job, and the Biden ad­min­is­tra­tion seems in­tent to just let Wood­cock serve as act­ing com­mis­sion­er for the fore­see­able fu­ture.

A for­mer FDA of­fi­cial told End­points News that he’s heard from peo­ple in the ad­min­is­tra­tion that they’re in no rush to nom­i­nate a per­ma­nent com­mis­sion­er be­cause they’re com­fort­able keep­ing Wood­cock, a 35-year vet­er­an of FDA, in the act­ing role.

Oth­er for­mer FDA of­fi­cials and com­mis­sion­ers are push­ing the Biden ad­min­is­tra­tion to nom­i­nate some­one quick­ly for the role.

Low­ell Schiller

“A strong, con­firmed Com­mis­sion­er is a vi­tal ad­vo­cate and cham­pi­on for the Agency, who can speak with the au­thor­i­ty and pres­i­den­tial sup­port that come from the con­fir­ma­tion process. With­out con­firmed lead­er­ship, it is more chal­leng­ing for FDA to set long-term pol­i­cy pri­or­i­ties, and to speak with a strong and in­de­pen­dent voice,” Low­ell Schiller, FDA’s for­mer prin­ci­pal as­so­ciate com­mis­sion­er for pol­i­cy, and chief le­gal and reg­u­la­to­ry of­fi­cer at Ae­tion, told End­points News. “That in­de­pen­dent voice is crit­i­cal at all times, and es­pe­cial­ly so dur­ing a glob­al pan­dem­ic.”

An­oth­er for­mer FDA of­fi­cial ex­pressed sur­prise in mid-Feb­ru­ary that a nom­i­na­tion hadn’t been made yet, but the of­fi­cial said that the agency was in a good place with Wood­cock, and that there were proac­tive cam­paigns in­side the FDA to name her as the per­ma­nent com­mis­sion­er. The of­fi­cial al­so said that Sharf­stein, at the time, was push­ing hard for the per­ma­nent role (Sharf­stein again de­clined to com­ment on this point).

Six for­mer FDA com­mis­sion­ers en­dorsed Wood­cock in a let­ter to Biden last month, urg­ing the ad­min­is­tra­tion to se­cure the agency’s lead­er­ship with a for­mal nom­i­na­tion. That lead­er­ship team has since tak­en a hit with the an­nounced de­par­ture lat­er this month of Amy Aber­nethy, FDA’s prin­ci­pal deputy com­mis­sion­er and act­ing chief in­for­ma­tion of­fi­cer.

But this lack of per­ma­nent lead­er­ship (soon to be in the top 2 spots at the agency) may not hold up more rou­tine FDA op­er­a­tions, like the draft­ing of new guid­ance.

Pa­tri­cia Zettler

“Es­pe­cial­ly with an act­ing com­mis­sion­er as ex­pe­ri­enced at the Agency as Dr. Wood­cock is, I don’t think that hav­ing an act­ing com­mis­sion­er should, as a prac­ti­cal mat­ter, hold up things like rou­tine guid­ance doc­u­ments [one new guid­ance has been re­leased since Biden took of­fice], and we’ve seen the agency take some in­ter­est­ing steps, like an­nounc­ing the April ad­vi­so­ry com­mit­tee meet­ing to re­view six on­col­o­gy in­di­ca­tions grant­ed ac­cel­er­at­ed ap­proval,” Pa­tri­cia Zettler, for­mer FDA lawyer and as­so­ciate pro­fes­sor of law at the Ohio State Uni­ver­si­ty, told End­points News via email. “That said, it might mean the Agency is less able or less will­ing to be­gin or an­nounce new, broad ini­tia­tives.”

An­drew Powale­ny

In­dus­try group PhRMA al­so agrees on the need for ur­gency.

“For the Agency to con­tin­ue pro­vid­ing crit­i­cal sci­ence-based reg­u­la­to­ry over­sight of our na­tion’s med­i­cine sup­ply, we be­lieve it is vi­tal for a qual­i­fied per­ma­nent com­mis­sion­er be named in a time­ly man­ner,” An­drew Powale­ny, se­nior di­rec­tor of pub­lic af­fairs at PhRMA, told End­points News via email.

Mov­ing for­ward, Biden will be re­quired by law to nom­i­nate some­one for the per­ma­nent slot by about mid-Au­gust, as ac­cord­ing to the Fed­er­al Va­can­cies Re­form Act, act­ing of­fi­cials can on­ly serve for 210 days and Wood­cock took over as act­ing com­mis­sion­er on Jan. 20 (al­though there is some wig­gle room on that dead­line).

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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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).

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.

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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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.