FDA and Pen­ta­gon forge break­through des­ig­na­tion agree­ment

Fol­low­ing the Pen­ta­gon’s crit­i­cism of the FDA slug­gish­ness in ap­prov­ing a French freeze-dried plas­ma prod­uct, which some have said oth­er coun­tries’ troops have used for years, FDA and the De­part­ment of De­fense’s Of­fice of Health Af­fairs on Tues­day launched a joint pro­gram to pri­or­i­tize the ef­fi­cient de­vel­op­ment of such med­ical prod­ucts.

The frame­work for the pro­gram was es­tab­lished, via H.R.4374, af­ter DoD sought to cre­ate its own re­view path­way where­by it could ap­prove med­ical prod­ucts out­side of FDA’s purview.

FDA and DoD out­lined their new ap­proach to col­lab­o­rat­ing in an ini­tial work plan, which in­cludes treat­ing “all pri­or­i­ty DoD de­vel­op­ment pro­grams as if they had re­ceived break­through des­ig­na­tion” and pro­vid­ing “ex­ten­sive man­u­fac­tur­ing and clin­i­cal ad­vice for pri­or­i­tized prod­ucts,” as well as is­su­ing guid­ance to fa­cil­i­tate the avail­abil­i­ty of prod­ucts need­ed by DoD.

Cur­rent high-pri­or­i­ty DoD prod­uct pro­grams in­clude freeze-dried plas­ma, cold-stored platelets and cry­op­re­served platelets, so the ini­tial phase of the pro­gram will be con­duct­ed by FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search and Health Af­fairs.

CBER se­nior lead­ers will com­plete a re­view of all prod­ucts de­ter­mined by mu­tu­al agree­ment to be a top pri­or­i­ty to DoD by 30 June 2018.

Tom Mc­Caf­fery

CBER will hold for­mal meet­ings with DoD at least semi­an­nu­al­ly to re­view the Pen­ta­gon’s prod­uct de­vel­op­ment pipeline, and the agen­cies will meet at least quar­ter­ly to have a de­tailed dis­cus­sion of the DoD’s high­est-pri­or­i­ty pro­grams. FDA and DoD will al­so hold at least one work­shop this year to dis­cuss as­pects of the sci­en­tif­ic and clin­i­cal de­vel­op­ment of prod­ucts for mil­i­tary per­sons and to in­form the guid­ance.

“This part­ner­ship re­flects the in­valu­able col­lab­o­ra­tion be­tween Health Af­fairs and the FDA to equip U.S. warfight­ers with the best pos­si­ble mil­i­tary med­ical sup­port as we work to achieve a safer, more se­cure world,” said Tom Mc­Caf­fery, act­ing as­sis­tant sec­re­tary of de­fense for Health Af­fairs. “Ex­pe­di­tious ac­cess to life-sav­ing med­ical prod­ucts for U.S. troops on the bat­tle­field is part and par­cel to en­sur­ing our shared pri­or­i­ty of op­er­a­tional readi­ness.”

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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

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Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

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PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

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Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

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Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

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