FDA opi­oid ad­comm chair blasts agency for 'will­ful blind­ness that bor­ders on the crim­i­nal'

In scathing re­marks di­rect­ed at the FDA’s han­dling of opi­oid ap­provals, the head of the agency’s ad­vi­so­ry pan­el has lam­bast­ed its “cozy, cozy re­la­tion­ships” with the phar­ma­ceu­ti­cal in­dus­try and called for a halt in con­sid­er­ing any new opi­oids for ap­proval.

Rae­ford Brown

Rae­ford Brown, chair of the FDA’s anes­thet­ic and anal­gesic drug prod­ucts ad­vi­so­ry com­mit­tee, did not pull any punch­es in his in­ter­view with the Guardian:

I think that the FDA has learned noth­ing. The modus operan­di of the agency is that they talk a good game and then noth­ing hap­pens. Work­ing di­rect­ly with the agency for the last five years, as I sit and lis­ten to them in meet­ings, all I can think about is the clock tick­ing and how many peo­ple are dy­ing every mo­ment that they’re not do­ing any­thing. The lack of in­sight that con­tin­ues to be ex­hib­it­ed by the agency is in many ways a will­ful blind­ness that bor­ders on the crim­i­nal.

The FDA’s ten­den­cy to put the in­ter­est of drug­mak­ers ahead of pub­lic health was most re­cent­ly man­i­fest­ed in the con­tro­ver­sial ap­proval of Acel­Rx’s Dsu­via, ac­cord­ing to Brown, an anes­the­si­ol­o­gist, who called it a “ter­ri­ble drug.”

Dsu­via was ap­proved fol­low­ing a 10-3 vote by the pan­el of out­side ex­perts in fa­vor of a green light, one year af­ter it was first re­ject­ed by the FDA. Brown was ab­sent from the ad­vi­so­ry pan­el meet­ing as he was away at a pro­fes­sion­al con­fer­ence.

“There’s no ques­tion in my mind right that they did that on pur­pose,” he told the Guardian. “The FDA has a lack of trans­paren­cy. They use the ad­vi­so­ry com­mit­tees as cov­er.”

The OK drew flak de­spite the lop­sided pan­el re­view vote as crit­ics pounced on the in­tro­duc­tion of an­oth­er pow­er­ful pain med that could be ripe for abuse. In a state­ment, FDA chief Scott Got­tlieb coun­tered his crit­ics by not­ing the need for a non-IV opi­oid as well as the de­fense de­part­ment’s de­mand for a ther­a­py that would be ben­e­fi­cial on the bat­tle­field.

That did lit­tle to con­vince Brown, who ac­cused FDA of­fi­cials of be­ing out of touch with the con­se­quences of the opi­oid epi­dem­ic, which has claimed hun­dreds of thou­sands of lives the in the US and con­tin­ues to be re­spon­si­ble for about 130 deaths every day.

“Noth­ing is fun­da­men­tal­ly be­ing done to ef­fect change in the reg­u­la­tion of opi­oids,” he said. “If the FDA con­tin­ues to en­cour­age the phar­ma­ceu­ti­cal in­dus­try to turn out opi­oid af­ter opi­oid af­ter opi­oid, and the reg­u­la­tion of those opi­oids is no bet­ter than it was in 1995, then we’ll be clean­ing this up for a long time.”

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.