Fol­low­ing up on Trump's or­ders, the FDA wants to know: which reg­u­la­tions and pa­per­work re­quire­ments need to go?

As part of work un­der two ex­ec­u­tive or­ders, FDA cen­ters on Thurs­day sought com­ments on which ex­ist­ing reg­u­la­tions and re­lat­ed pa­per­work re­quire­ments could be mod­i­fied, re­pealed or re­placed, to re­duce the bur­den on in­dus­try while al­low­ing the reg­u­la­tor to con­tin­ue its pub­lic health mis­sion while ful­fill­ing statu­to­ry oblig­a­tions.

Back in Feb­ru­ary, when Pres­i­dent Don­ald Trump first an­nounced his or­der to re­duce reg­u­la­to­ry bur­dens, sev­er­al ex­perts point­ed Fo­cus to some out­dat­ed reg­u­la­tions that could be re­moved with lit­tle im­pact on pub­lic health and the agency’s mis­sion, though there are still ques­tions as to what types of reg­u­la­tions will be tar­get­ed.

And as An­na Abram, FDA’s deputy com­mis­sion­er for pol­i­cy, plan­ning, leg­is­la­tion and analy­sis, not­ed in a blog post on Thurs­day, there’s “a lot of ground to cov­er” as FDA’s reg­u­la­tions com­prise more than 4,000 pages in the Code of Fed­er­al Reg­u­la­tions.

In gen­er­al, though, the agency says it’s look­ing for com­ment and sup­port­ing tech­ni­cal, sci­en­tif­ic, eco­nom­ic or oth­er da­ta from those sig­nif­i­cant­ly af­fect­ed by FDA reg­u­la­tions, in­clud­ing con­sumers, pa­tients and care­givers, re­searchers, health­care in­sti­tu­tions, the reg­u­lat­ed in­dus­try, trade as­so­ci­a­tions, pub­lic in­ter­est or­ga­ni­za­tions, acad­e­mia, and state, lo­cal and trib­al gov­ern­ments.

“Some reg­u­la­tions may not ad­e­quate­ly re­flect ad­vances in sci­ence, tech­nol­o­gy or changes in in­dus­try prac­tice. Oth­ers may be geared to­ward prod­ucts and prac­tices that have large­ly ceased to ex­ist,” Abram said, of­fer­ing the ex­am­ple of how the ma­nip­u­la­tion of FDA’s rules on Risk Eval­u­a­tion and Mit­i­ga­tion Strate­gies (REMS) can cre­ate ob­sta­cles to the time­ly en­try of gener­ic com­pe­ti­tion.

Fea­tured in Thurs­day’s Fed­er­al Reg­is­ter no­tices are ques­tions FDA says it is us­ing to guide its ini­tial re­view, in­clud­ing:

  • Is the reg­u­la­tion still cur­rent, or is it out­dat­ed or un­nec­es­sary in some way?
  • Have reg­u­lat­ed en­ti­ties had dif­fi­cul­ties com­ply­ing with the reg­u­la­tion?
  • Does the reg­u­la­tion im­pose re­quire­ments that are al­so pro­vid­ed for in vol­un­tary or con­sen­sus stan­dards or guid­ance by third par­ty or­ga­ni­za­tions (e.g., In­ter­na­tion­al Coun­cil for Har­mon­i­sa­tion, In­ter­na­tion­al Or­ga­ni­za­tion for Stan­dard­iza­tion, Codex Al­i­men­ta­r­ius)?
  • Does the reg­u­la­tion con­tain re­dun­dant, out­dat­ed, or un­nec­es­sary col­lec­tions of in­for­ma­tion or re­ten­tion of records, e.g., re­port­ing, record­keep­ing, or la­bel­ing re­quire­ments?
  • Could the goal of the reg­u­la­tion be achieved by less cost­ly means that would pro­vide the same lev­el of pub­lic health pro­tec­tion?
  • What fac­tors should FDA con­sid­er in se­lect­ing and pri­or­i­tiz­ing reg­u­la­tions and re­port­ing re­quire­ments for re­form?

Links

Re­view of Ex­ist­ing Gen­er­al Reg­u­la­to­ry and In­for­ma­tion Col­lec­tion Re­quire­ments of the Food and Drug Ad­min­is­tra­tion

Re­view of Ex­ist­ing Cen­ter for Drug Eval­u­a­tion and Re­search Reg­u­la­to­ry and In­for­ma­tion Col­lec­tion Re­quire­ments

Re­view of Ex­ist­ing Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search Reg­u­la­to­ry and In­for­ma­tion Col­lec­tion Re­quire­ments

Re­view of Ex­ist­ing Cen­ter for De­vices and Ra­di­o­log­i­cal Health Reg­u­la­to­ry and In­for­ma­tion Col­lec­tion Re­quire­ments


Im­age: Get­ty, End­points News, The White House

First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Author

Zachary Brennan

managing editor, RAPS

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

In fi­nal re­port, ICER ap­pears to have a change of heart on new acute mi­graine ther­a­pies

ICER appears to have reversed course on the fresh crop of acute migraine therapies.

The cost-effectiveness watchdog in November issued a draft report suggesting that existing generic medicines are more effective and cheaper than Allergan’s December-approved CGRP ubrogepant, Biohaven rival molecule, rimegepant (which is under FDA review), and Lilly’s October-sanctioned lasmiditan, which binds to 5-HT1F receptors.

Bi­cy­cle Ther­a­peu­tics takes Roche's Genen­tech on an up to $2B im­muno-on­col­o­gy ride

Bicycle Therapeutics — which is developing a new class of chemically synthesized drugs designed to be pharmacologically as active as biologics, yet manufactured as small molecules —  has scored another big partner: Roche’s Genentech.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.

When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.

The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.

Anthony Fauci, AP Images

First US Covid-19 tri­als set to get un­der­way in Ne­bras­ka and Wash­ing­ton, backed by NIH

The first US clinical trials on the novel coronavirus are scheduled to get underway next month at the University of Nebraska Medical Center, where American passengers were taken after being evacuated from the Diamond Princess cruise ship, and at the Kaiser Permanente Washington Health Research Institute. Both trials are sponsored by the NIH’s National Institute for Allergy and Infectious Diseases, which has led the US’s medical response to the outbreak.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,000+ biopharma pros reading Endpoints daily — and it's free.