Thanks to Supreme Court de­ci­sion, Mer­ck gets an­oth­er chance to throw out Fos­amax claims

In a tem­po­rary re­lief for Mer­ck amid on­go­ing le­gal dra­ma sur­round­ing its os­teo­poro­sis drug Fos­amax, the Supreme Court has va­cat­ed the judg­ment of a low­er court and di­rect­ed it to re­con­sid­er a rul­ing that al­lowed law­suits to go to tri­al.

While the jus­tices did not weigh in on the mer­its of those law­suits, the de­ci­sion re­vives Mer­ck’s hopes of throw­ing out hun­dreds of pa­tients claims, which ac­cuse the phar­ma gi­ant of vi­o­lat­ing state laws by ne­glect­ing to warn them of risks as­so­ci­at­ed with Fos­amax for over a decade. Even though sci­en­tists had spec­u­lat­ed that Fos­amax — a bis­pho­s­pho­nate de­signed to pre­vent os­teo­porot­ic frac­tures — could in­crease the risk of atyp­i­cal femoral frac­tures be­fore the FDA ap­proved the drug in 1995, the la­bel did not fea­ture a warn­ing on that score. De­spite sub­se­quent ev­i­dence from pa­tient re­ports con­firm­ing the risk, a warn­ing was not added un­til 2010 fol­low­ing an or­der from reg­u­la­tors.

Why didn’t Mer­ck do any­thing about it dur­ing that time? It’s not for lack of try­ing, the com­pa­ny ar­gues. Rather, its at­tempt to add a warn­ing to the la­bel was re­ject­ed by the FDA, free­ing it of any le­gal re­spon­si­bil­i­ty for fail­ure to warn.

Stephen Brey­er

Key to val­i­dat­ing that ar­gu­ment is a le­gal prin­ci­ple in fed­er­al-state re­la­tions known as pre-emp­tion. In this case — fol­low­ing a 2009 prece­dent set in Wyeth v. Levine — it means that when there is “clear ev­i­dence” that the FDA would not have ap­proved the warn­ing that state law re­quires, the drug man­u­fac­tur­er could not be blamed for fail­ing to com­ply with that state law.

The plain­tiffs might dis­agree on whether that cri­te­ria is met. In fact, Jus­tice Stephen Brey­er ac­knowl­edged in the ma­jor­i­ty opin­ion that the FDA turned down Mer­ck’s pro­posed change on the grounds that it was “in­ad­e­quate” and in­vit­ed them to re­sub­mit an ap­pli­ca­tion to ful­ly ad­dress its de­fi­cien­cies. But that’s up for a judge, not a ju­ry, to de­cide — con­tra­dict­ing the de­ci­sion of the 2017 rul­ing by the Court of Ap­peals for the Third Cir­cuit.

That’s where the case, 17-290 Mer­ck Sharp & Dohme Corp. v. Al­brecht, is head­ed back now.

From the head­note sum­ming up the unan­i­mous rul­ing:

The ques­tion of agency dis­ap­proval is pri­mar­i­ly one of law for a judge to de­cide. The ques­tion of­ten in­volves the use of le­gal skills to de­ter­mine whether agency dis­ap­proval fits facts that are not in dis­pute. More­over, judges, rather than lay ju­ries, are bet­ter equipped to eval­u­ate the na­ture and scope of an agency’s de­ter­mi­na­tion, and are bet­ter suit­ed to un­der­stand and to in­ter­pret agency de­ci­sions in light of the gov­ern­ing statu­to­ry and reg­u­la­to­ry con­text. While con­test­ed brute facts will some­times prove rel­e­vant to a court’s le­gal de­ter­mi­na­tion about the mean­ing and ef­fect of an agency de­ci­sion, such fac­tu­al ques­tions are sub­sumed with­in an al­ready tight­ly cir­cum­scribed le­gal analy­sis and do not war­rant sub­mis­sion alone or to­geth­er with the larg­er pre-emp­tion ques­tion to a ju­ry.

Law­suits against Mer­ck on Fos­amax first emerged around 2009, af­ter the drug had gone gener­ic. It still gar­nered $209 mil­lion in sales last year, ac­cord­ing to fi­nan­cial re­ports.


Im­age source: Shut­ter­stock

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.