HHS post­pones re­view of over 95% of FDA’s reg­u­la­tions so crit­i­cal re­sources are not di­vert­ed from Covid-19

The De­part­ment of Health and Hu­man Ser­vices said late Thurs­day that it’s post­pon­ing a last-minute rule en­act­ed by for­mer Pres­i­dent Trump’s HHS that would’ve re­quired the FDA to re­view al­most every one of its reg­u­la­tions, which would’ve di­vert­ed nec­es­sary re­sources away from the agency’s on­go­ing work on the pan­dem­ic.

“Based on a count cit­ed in the SUN­SET fi­nal rule, un­der the time­line and de­f­i­n­i­tions pro­vid­ed in the fi­nal rule, over 7,000 sec­tions of the Code of Fed­er­al Reg­u­la­tions pro­mul­gat­ed by the Food and Drug Ad­min­is­tra­tion (FDA) are more than ten years old or would be­come more than ten years old dur­ing the first five years the rule would be in ef­fect, rep­re­sent­ing over 95 per­cent of its cur­rent reg­u­la­tions,” HHS said in an­nounc­ing the post­pone­ment.

HHS al­so said in its Fed­er­al Reg­is­ter no­tice that if the sun­set fi­nal rule be­came ef­fec­tive as sched­uled on March 22, then to avoid au­to­mat­ic ex­pi­ra­tion of these reg­u­la­tions, FDA and HHS “would need to im­me­di­ate­ly di­vert re­sources to­ward as­sess­ment and re­view dur­ing the on­go­ing COVID-19 pub­lic health emer­gency. In that event, FDA’s re­views of med­ical prod­uct ap­pli­ca­tions, ful­fill­ment of user fee com­mit­ments, and ac­tions to ad­dress ur­gent pub­lic health mat­ters such as on­go­ing COVID-19 pan­dem­ic re­lief ef­forts, out­breaks of food­borne ill­ness, in­spec­tions, re­calls, and oth­er pub­lic health pri­or­i­ties would be sig­nif­i­cant­ly im­pact­ed.

“This con­cen­tra­tion of re­sources in con­duct­ing reg­u­la­to­ry re­view pur­suant to the SUN­SET rule could pre­vent FDA from mod­ern­iz­ing its reg­u­la­to­ry over­sight more ef­fi­cient­ly and ad­dress­ing new reg­u­la­to­ry needs,” HHS added, not­ing that it’ll de­lay the ef­fec­tive date of the rule by a year.

The de­part­ment al­so said that it thinks a re­cent law­suit from the Cen­ter for Sci­ence in the Pub­lic In­ter­est and oth­er groups to over­turn the rule has some mer­its, and that this ex­ten­sion will al­low the suit to pro­ceed.

“Based on HHS’s ini­tial re­view of the Com­plaint, HHS be­lieves that the Court could find mer­it in some of Plain­tiffs’ claims,” HHS said. “Plain­tiffs’ al­le­ga­tions of harm are cred­i­ble; a post­pone­ment will per­mit HHS to re­view the SUN­SET fi­nal rule in light of the claims raised in the lit­i­ga­tion; and the bal­ance of eq­ui­ties and the pub­lic in­ter­est war­rant post­pone­ment of the ef­fec­tive date to pre­serve the sta­tus quo while the Court con­sid­ers the chal­lenge to the SUN­SET fi­nal rule.”

If the suit does not halt the rule, the Biden ad­min­is­tra­tion could just with­draw it, ex­perts pre­vi­ous­ly told End­points News, al­though HHS would still need to go through a no­tice-and-com­ment pro­ce­dure to do so.

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.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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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.

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.

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FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.

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.

A CRL lat­er, Gilead clears clin­i­cal hold on next-gen HIV drug — af­ter find­ing a new glass vial for it

Back in late December, the FDA flagged concerns about the glass vials Gilead used to contain its experimental HIV therapy lenacapavir, citing risks of forming sub-visible glass particles in the drug solution.

Those issues were serious enough to trigger a clinical hold on 10 trials — and ultimately a rejection.

Two months after the complete response letter, Gilead said it’s finally found a solution that satisfies the FDA, which is lifting the clinical hold.

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Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

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