Sen. Bernie Sanders (Michael Brochstein/Sipa via AP Images)

‘A mess across the board’: Sen­ate com­mit­tee kicks off talks on drug pric­ing re­forms

The US is still the on­ly coun­try in the world that doesn’t ne­go­ti­ate phar­ma­ceu­ti­cal prices across the board, ex­perts told a Sen­ate com­mit­tee on Tues­day, but how ex­act­ly to fix that re­mains un­clear and few of the so­lu­tions dis­cussed will sur­prise any­one watch­ing the pric­ing de­bate play out over the last decade.

Set­ting the tone for the hear­ing, which fea­tured com­ments from a type 1 di­a­betes pa­tient, Elia Spates, who has seen her in­sulin costs triple over about a decade, Sen. Bernie Sanders (I-VT) honed in on the fact that Spates is not alone, and 1 out of 5 Amer­i­cans could not af­ford their pre­scrip­tion drugs last year.

“How crazy is that?” he asked rhetor­i­cal­ly.

Sanders re­cent­ly in­tro­duced three bills co-spon­sored by oth­er De­moc­rats to tack­le drug prices, of­fer­ing re­cy­cled ideas on peg­ging the price of drugs in the US to for­eign coun­tries’ prices (an idea al­so float­ed by for­mer Pres­i­dent Trump), al­low­ing HHS to ne­go­ti­ate drug prices un­der Medicare Part D (which has been de­bat­ed for more than a decade), and al­low­ing drug im­ports from Cana­da (which is al­ready on­go­ing).

Aaron Kessel­heim

Ex­perts at the hear­ing of­fered their own so­lu­tions for what should be done. Aaron Kessel­heim, pro­fes­sor of med­i­cine at Har­vard Med­ical School, ex­plained a more de­tailed ap­proach – call­ing for the US to eval­u­ate new drugs up­front based on a re­view of their clin­i­cal ben­e­fits and then al­low­ing the gov­ern­ment to ne­go­ti­ate prices based on their find­ings. He al­so called for the fed­er­al gov­ern­ment to crack down on price in­creas­es “well be­yond in­fla­tion,” and to en­sure that patents for new med­i­cines are le­git­i­mate.

“The phar­ma­ceu­ti­cal lob­by is large and well-fund­ed and will ar­gue that any re­duc­tion in rev­enues will harm in­no­va­tion. But most drugs ap­proved each year are not tru­ly in­no­v­a­tive and in a re­view of 2017 new ap­provals, on­ly a mi­nor­i­ty of those re­viewed by in­de­pen­dent ex­pert bod­ies of­fered more than min­i­mal clin­i­cal ad­van­tages over avail­able treat­ments,” he said in his writ­ten tes­ti­mo­ny.

But De­moc­rats hold a ra­zor-thin ma­jor­i­ty in the Sen­ate, mean­ing Re­pub­li­cans will need to be won over to get a stand­alone bill passed.

Alex Law­son, the ex­ec­u­tive di­rec­tor of So­cial Se­cu­ri­ty Works who’s been work­ing be­hind the scenes on drug pric­ing on Capi­tol Hill, told End­points News in a phone in­ter­view that he thinks ma­jor drug pric­ing re­forms will be tagged on­to an­oth­er in­fra­struc­ture bill, which has to hap­pen be­fore Sep­tem­ber, be­cause it would be im­pos­si­ble for the De­moc­rats to get 60 votes to pass a stand­alone bill.

Alex Law­son

“I think ne­go­ti­a­tion will be the heart of what it is – some form of ne­go­ti­a­tion,” he said. “In­dus­try thinks that they won’t have to deal with ex­tra­or­di­nar­i­ly high drug prices be­cause the vac­cines are turn­ing the cor­ner on this pan­dem­ic, and I think they’re sore­ly mis­tak­en.”

The idea of hav­ing the sav­ings from high drug prices pay for new in­fra­struc­ture is al­so at­trac­tive to De­moc­rats, he not­ed.

But some Re­pub­li­cans, hes­i­tant to harm a biotech ecosys­tem that is flour­ish­ing and has brought the US mul­ti­ple Covid-19 vac­cines in less than a year, fo­cused their com­ments Tues­day on ways to re­duce pa­tients’ out-of-pock­et ex­pens­es with­out hurt­ing drug­mak­ers’ bot­tom lines, as well as ways to in­crease trans­paren­cy and en­sure re­bates end up in pa­tients’ pock­ets.

Louisiana Re­pub­li­can Bill Cas­sidy al­so ex­pressed con­cerns about the fed­er­al gov­ern­ment set­ting drug prices uni­lat­er­al­ly, which could have a chill­ing ef­fect on VCs that fund the work that takes a com­pound from the bench to a tri­al, and are ex­pect­ing a re­turn on their in­vest­ments.

Re­pub­li­can Su­san Collins of Maine not­ed she hopes Con­gress can find com­mon ground on the is­sue of drug prices be­cause “when a doc­tor pre­scribes a need­ed med­ica­tion, an in­sur­mount­able is­sue should not be the cost.”

In­di­ana Re­pub­li­can Mike Braun, how­ev­er, went in the oth­er di­rec­tion and in­di­cat­ed a will­ing­ness to let the gov­ern­ment step in, call­ing the cur­rent drug pric­ing sys­tem “a mess across the board.” He al­so said of the phar­ma­ceu­ti­cal in­dus­try, “There is no oth­er sec­tor of our econ­o­my that has less trans­paren­cy, less com­pe­ti­tion and more bar­ri­ers to en­try and dis­en­gaged con­sumers. One al­ter­na­tive is to bring in gov­ern­ment.”

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,400+ biopharma pros reading Endpoints daily — and it's free.

Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Frank Pallone (D-NJ), House Energy and Commerce Committee chair (Kevin Dietsch/Pool via AP Images)

House com­mit­tee unan­i­mous­ly ad­vances FDA user fee leg­is­la­tion with ac­cel­er­at­ed ap­proval tweaks

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.

Lina Khan, FTC chair (Saul Loeb/Pool via AP)

New FTC com­mis­sion­er could turn the tide for an in­ves­ti­ga­tion in­to PBMs

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

Patty Murray (D-WA) (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,400+ biopharma pros reading Endpoints daily — and it's free.

Pri­cy in­halers re­main ex­pen­sive due to de­vice tweaks that keep com­peti­tors at bay, re­searchers find

New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.

A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from generic competition.