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.

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

BREAK­ING: Mer­ck makes a triple play on Covid-19: buy­ing out a vac­cine biotech, part­ner­ing on an­oth­er pro­gram and adding an an­tivi­ral to the mix

Merck is making a triple play in a sudden leap into the R&D campaign against Covid-19.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

The deal with IAVI covers recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s successful Ebola Zaire virus vaccine. That’s going into the clinic later this year.

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Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Piv­otal myas­the­nia gravis da­ta from ar­genx au­gur well for FcRn in­hibitors in de­vel­op­ment

Leading the pack of biotechs vying for a piece of the generalized myasthenia gravis (gMG) market with an FcRn inhibitor, argenx on Tuesday unveiled keenly anticipated positive late-stage data on its lead asset, bringing it one step closer to regulatory approval.

Despite steroids, immunosuppressants, acetylcholinesterase inhibitors, and Alexion’s Soliris, patients with the rare, chronic neuromuscular disorder (more than 100,000 in the United States and Europe) don’t necessarily benefit from these existing options, leaving room for the crop of FcRn inhibitors in development.

Covid-19 roundup: Janet Wood­cock steps aside — for now — as FDA drug czar; WHO hits the brakes on hy­droxy study af­ter lat­est safe­ty alarm

The biopharma industry will soon get a look at what the FDA will look like once CDER’s powerful chief Janet Woodcock retires from her post.

Long considered one of the most influential regulators in the agency, if not its single most powerful official when it counts, Woodcock is being detached to devote herself full-time to the White House’s special project to fast-forward new drugs and vaccines for the pandemic. The move comes a week after some quick reshuffling as Woodcock and CBER chief Peter Marks joined Operation Warp Speed. Initially they opted to recuse themselves from any FDA decisions on pandemic treatments and vaccines, after consumer advocates criticized the move as a clear conflict of interest in how the agency exercises oversight on new approvals.

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Eric Edwards, Phlow president and CEO (PR Newswire)

BAR­DA of­fers a tiny start­up up to $812M to cre­ate a US-based drug man­u­fac­tur­er — and the CEO comes with a price goug­ing con­tro­ver­sy on his ré­sumé

BARDA has tapped a largely unknown startup to ramp up production of a list of drugs that may be at risk of running short in the US. And the deal, which comes with up to $812 million in federal funds, was inked by a CEO who found himself in the middle of an ugly price gouging controversy a few years ago.

The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.

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Re­searchers de­fine ex­act­ly what they saw in the first pos­i­tive remde­sivir study for Covid-19. But what's that worth to Gilead?

Remdesivir can work in fighting Covid-19, particularly for patients with less severe cases, but this is just a first step in the journey to finding combos that can do the job much better.

That’s the bottom line from Gilead’s randomized study published in the New England Journal of Medicine. Analysts were quick to draw conclusions about how the big biotech could turn this into a profitable advantage — with widespread expectation of considerable pricing restraint on Gilead’s part. Anyone looking for a new mountain of cash to count as the world grapples with the pandemic is likely to come away disappointed.

Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Covid-19 roundup: Hit with new con­flict ac­cu­sa­tions, Janet Wood­cock steps out of the agen­cy's Covid-19 chain of com­mand

Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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An­oth­er NASH de­lay for In­ter­cept frus­trates in­vestors, shares wilt

A previous FDA advisory committee delay for Intercept’s NASH drug may have dampened spirits, but investors perked up after French rival Genfit recently failed to best a placebo with its offering in a keenly anticipated pivotal study. In yet another twist on Friday, the New York drugmaker said the FDA is postponing its adcom again to accommodate the review of additional data it has asked the company to furnish.

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