Some wor­thy ini­tia­tives out of the FDA fall far short of an ef­fec­tive fed­er­al plan to rein in drug prices

Over the last five months I’ve spent more time watch­ing video streams out of the na­tion’s cap­i­tal than I did in all of the past five years (thank you C-Span). Law­mak­ers, over­all, have been very oblig­ing to the bio­phar­ma in­dus­try on a bi­par­ti­san ba­sis. And when there was ir­reg­u­lar news to re­port from DC, it gen­er­al­ly dealt with is­sues like an ex­tend­ed pe­ri­od of ex­clu­siv­i­ty for bi­o­log­ics or fresh de­mands for swifter drug re­views cou­pled to new in­cen­tives.

Iron­i­cal­ly, the drug in­dus­try proved one of the very few ar­eas where Re­pub­li­cans and De­moc­rats gen­er­al­ly found it easy to co­op­er­ate on a bi­par­ti­san ba­sis.

That all changed the day Don­ald Trump was sworn in as pres­i­dent.

Trump made pub­licly whip­ping bio­phar­ma a reg­u­lar spec­ta­cle. The in­dus­try had too many over­seas jobs, he de­clared with pop­ulist fer­vor, didn’t in­vest in Amer­i­ca and more than any­thing, en­gaged in rip­ping off the coun­try with out­ra­geous­ly high drug prices.

Phar­ma ex­ec­u­tives are a sen­si­tive sort when it comes to pric­ing dis­cus­sions in gen­er­al, and you’d be hard pressed to find any ma­jor play­er who isn’t painful­ly aware of the new pric­ing en­vi­ron­ment.

The big dis­count price on sar­ilum­ab from Sanofi and Re­gen­eron re­flects in part the im­pact Trump has had. Most of the biggest com­pa­nies have al­so come up with some new method for cal­cu­lat­ing ac­cept­able drug price in­creas­es. That didn’t hap­pen in a vac­u­um.

Ge­of­frey Porges, Leerink

So some in­dus­try in­sid­ers may have found it odd that Leerink’s Ge­of­frey Porges thinks that the whole Big Phar­ma as­sault from DC may well just pe­ter out, leav­ing a few scuff marks be­hind af­ter limbs had been threat­ened.

I was think­ing that when I watched FDA com­mis­sion­er Scott Got­tlieb tes­ti­fy in front of a Con­gres­sion­al sub­com­mit­tee on Thurs­day. Got­tlieb has a few good ideas on drug pric­ing. It’s sim­ple com­mon sense that clear­ing up a back­log of gener­ics ap­pli­ca­tions and specif­i­cal­ly tar­get­ing the ap­proval path­way for com­plex gener­ics can have a re­al ef­fect on what this coun­try pays for drugs. Gener­ic com­pe­ti­tion can shred a brand­ed price in months. And we’ll like­ly see biosim­i­lars start to have an im­pact af­ter we see a num­ber of ri­vals ap­pear for every ag­ing block­buster.

If that’s it — with no Medicare ne­go­ti­a­tions or tough fed­er­al for­mu­la­ries that can kick off the most ex­pen­sive meds — then the in­dus­try chiefs will have dodged a can­non ball. Bio­phar­ma can deal with the mar­ket re­al­i­ties of gener­ics. And aban­don­ing the end-game of pro­tect­ing fran­chise drugs with var­i­ous de­lay­ing tac­tics is in the pub­lic in­ter­est.

But that won’t ad­dress the un­der­ly­ing is­sue of brand­ed drug prices in the US.

FDA com­mis­sion­er Scott Got­tlieb

Ul­ti­mate­ly, mar­ket forces may be left as the on­ly vi­able tool for re­strict­ing new drug prices. That’s not nec­es­sar­i­ly a bad thing. But the way it works now cre­ates huge is­sues for pa­tients.

Left to their own de­vices, pay­ers have come up with their own way to de­ny the peo­ple they cov­er ac­cess to ex­pen­sive drugs. Step ther­a­py has be­come a 100 mile jour­ney for some pa­tients. Rules sup­pos­ed­ly aimed at re­strict­ing cov­er­age to those who can ben­e­fit from a drug are of­ten just drawn up to bar cov­er­age. Out-of-pock­et ex­pens­es keep go­ing high­er to wave off prop­er use.

US con­sumers should have ac­cess to new drugs at a fair price.

There has to be a bet­ter way than this to man­age the pric­ing is­sue. But we may not see it any­time soon. And that means the pric­ing con­tro­ver­sy will con­tin­ue to fes­ter in­def­i­nite­ly.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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