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).

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.

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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?
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Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

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Io­n­is, Akcea boost­ed by a pos­i­tive PhII for their No­var­tis castoff car­dio drug — and they plan to push ahead in­to piv­otals

Late last year Novartis abandoned a cardio drug from Ionis’ spinoff Akcea just after the pharma giant snapped up inclisiran, going the RNAi way in guarding against heart disease in the $9.7 billion Medco buyout.

Now the pharma goliath — which is headed down the PCSK9 road with a drug it believes can be used in a mass population — can get a clearer picture of just what they gave up.

Akcea $AKCA and the mother company $IONS put out a statement early Wednesday saying that their Phase II study of AKCEA-APOCIII-LR delivered solid efficacy data, with the high dose clearly outperforming placebo in significantly reducing triglycerides as a means to cutting the risk of cardiovascular disease. In addition, investigators concluded that the drug slashed apoC-III, very low-density lipoprotein and remnant cholesterol while boosting “good” HDL levels.

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Who are the young bio­phar­ma lead­ers shap­ing the in­dus­try? Nom­i­nate them for End­points' spe­cial re­port

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Two years ago, when we did our first Endpoints 20-under-40, we profiled a set of up-and-comers who promised to help reshape the industry as we know it. Now we’re back and once again looking for the top 20 biopharma professionals under the age of 40. We’ll be profiling folks who have accomplished a lot at a young age but seem on the verge of accomplishing so much more.