Elizabeth Warren and Amy Klobuchar, AP Images

War­ren and Klobuchar say they can low­er drug prices with­out Con­gress’ help

On Tues­day, two De­moc­rats run­ning for pres­i­dent promised to do — each by her­self — what Wash­ing­ton has so far proven un­able to do: low­er the prices of pre­scrip­tion drugs.

Speak­ing dur­ing the last De­mo­c­ra­t­ic de­bate be­fore the Iowa cau­cus on Feb. 3, Sen. Eliz­a­beth War­ren of Mass­a­chu­setts and Sen. Amy Klobuchar of Min­neso­ta said, if elect­ed pres­i­dent, they would each act im­me­di­ate­ly to di­rect­ly re­duce the cost of cer­tain drugs.

Their de­c­la­ra­tions, com­ing from two sen­a­tors who have spon­sored their own bills to con­trol sky­rock­et­ing drug prices, stood out af­ter Con­gress spent last year de­bat­ing the prob­lem — and failed to pass sig­nif­i­cant leg­is­la­tion to fix it.

“We need to get as much help to peo­ple as we can, as soon as pos­si­ble,” War­ren said.

While they did not elab­o­rate on which pres­i­den­tial pow­ers they would use, War­ren and Klobuchar said the pres­i­dent al­ready has the le­gal au­thor­i­ty to rein in drug prices. (Klobuchar ac­tu­al­ly has a list of 137 things that she could do with­out Con­gres­sion­al ac­tion that in­clude but are not lim­it­ed to ac­tion on drug pric­ing.)

A 2019 poll from the Kaiser Fam­i­ly Foun­da­tion found that, due to cost, about 29% of Amer­i­cans had not tak­en a pre­scrip­tion as di­rect­ed in the pre­vi­ous year.

Hav­ing pro­posed leg­is­la­tion that would em­pow­er the fed­er­al gov­ern­ment to man­u­fac­ture drugs it­self, War­ren said she would act to low­er the price of in­sulin and drugs that treat HIV/AIDS.

Her cam­paign emailed re­porters a list of oth­er tar­get­ed drugs, in­clud­ing the EpiPen; Hu­mi­ra, the top-sell­ing rheuma­toid arthri­tis drug whose mak­er has been crit­i­cized for abus­ing patents to sti­fle com­pe­ti­tion; and Nalox­one, a drug that re­vers­es the ef­fects of opi­oid over­dose.

Klobuchar and for­mer May­or Pe­te Buttigieg of South Bend, IN, al­so en­dorsed em­pow­er­ing Medicare to ne­go­ti­ate low­er prices with drug­mak­ers — the pro­pos­al at the heart of the drug plan un­veiled last year by Speak­er Nan­cy Pelosi and oth­er House De­mo­c­ra­t­ic lead­ers.

How­ev­er, that idea is deeply un­pop­u­lar with con­gres­sion­al Re­pub­li­cans, who de­scribe it as gov­ern­ment in­ter­fer­ence in the free mar­ket. While the bill passed the House in De­cem­ber, Sen. Mitch Mc­Connell of Ken­tucky, the Re­pub­li­can leader, has said he will not al­low it to get a vote in the Sen­ate, killing its chances, at least for now.

Klobuchar said the re­al prob­lem is the num­ber of phar­ma­ceu­ti­cal lob­by­ists on Capi­tol Hill — two to every mem­ber of Con­gress, she said. Poli­ti­Fact rat­ed this claim Most­ly True last year.

“How do we ac­tu­al­ly break the cor­po­rate stran­gle­hold on our gov­ern­ment so we can get any of these things passed?” said Tom Stey­er, a busi­ness­man who was one of the six De­mo­c­ra­t­ic can­di­dates to qual­i­fy for the de­bate.

The de­bate, which took place in Des Moines less than three weeks be­fore vot­ing be­gins, gave for­mer Vice Pres­i­dent Joe Biden and Sen. Bernie Sanders of Ver­mont an­oth­er op­por­tu­ni­ty to spar over the cost of “Medicare for All,” al­beit on­ly briefly.

Elab­o­rat­ing on how he would pay for his sin­gle-pay­er over­haul of the na­tion’s health care sys­tem, Sanders said it would in­volve a 4% in­come tax, ex­empt­ing the first $29,000 of a tax­pay­er’s in­come to ease the bur­den on the “av­er­age fam­i­ly in Amer­i­ca.”

“Now is the time to take on the greed and cor­rup­tion of the health care in­dus­try, of the drug com­pa­nies, and fi­nal­ly pro­vide health care to all through a Medicare for All sin­gle-pay­er pro­gram,” Sanders said. “It won’t be easy. It’s what we have to do.”

“You can do it with­out Medicare for All,” Biden said. “You can get to the same place.”

Af­ter six de­bates spent pars­ing the de­tails of Medicare for All, though, War­ren ref­er­enced what comes next: a gen­er­al elec­tion dur­ing which the De­mo­c­ra­t­ic nom­i­nee will run against Pres­i­dent Don­ald Trump, a Re­pub­li­can who wants to re­peal the Af­ford­able Care Act.

War­ren said she would push her plan to ex­pand cov­er­age through a sin­gle-pay­er sys­tem — but al­so that she would de­fend the Af­ford­able Care Act.

“I’ll take our side of the ar­gu­ment any day,” she said. “We’re go­ing to beat him on this.”

The eighth de­bate is sched­uled for Feb. 8, the first of three De­mo­c­ra­t­ic de­bates next month.

This sto­ry was orig­i­nal­ly pub­lished by Kaiser Health News, a na­tion­al health pol­i­cy news ser­vice. It is an ed­i­to­ri­al­ly in­de­pen­dent pro­gram of the Hen­ry J. Kaiser Fam­i­ly Foun­da­tion which is not af­fil­i­at­ed with Kaiser Per­ma­nente. Writ­ten by Em­marie Huet­te­man: ehuet­te­man@kff.org

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,500+ biopharma pros reading Endpoints daily — and it's free.

Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,500+ biopharma pros reading Endpoints daily — and it's free.

Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,500+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,500+ biopharma pros reading Endpoints daily — and it's free.

Gilead claims Tru­va­da patents in HHS’ com­plaint are in­valid

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

Gilead dusts off a failed Ebo­la drug as coro­n­avirus spreads; Ex­elix­is boasts pos­i­tive Ph I/II da­ta

→ Less than a year ago Gilead’s antiviral remdesivir failed to make the cut as investigators considered a raft of potential drugs that could be used against an Ebola outbreak. But it may gain a new mission with the outbreak of the coronavirus in China, which is popping up now around the world.

Gilead put out a statement saying that they’re now in discussions with health officials in the US and China about testing their NUC against the virus. It’s the latest in a growing lineup of biopharma companies that are marshaling R&D forces to see if they can come up with a vaccine or therapy to blunt the spread of the virus, which has now sickened hundreds, killed at least 17 people and led the Chinese government to start quarantining cities.

Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,500+ biopharma pros reading Endpoints daily — and it's free.