Janet Woodcock (Credit: CQ Roll Call/AP)

For­eign drug in­spec­tions de­cline as FDA hir­ing strug­gles con­tin­ue

The US re­liance on im­port­ed phar­ma­ceu­ti­cals and in­gre­di­ents is ris­ing as for­eign drug fa­cil­i­ty in­spec­tions de­creased by about 10% from 2016 to 2018. Part of the rea­son for the de­cline: The US Food and Drug Ad­min­is­tra­tion (FDA) said it’s still strug­gling to hire new in­spec­tors.

Tes­ti­fy­ing be­fore a House sub­com­mit­tee on Tues­day, Janet Wood­cock, di­rec­tor of FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search, de­fend­ed the agency’s ap­proach and dis­cussed some of the vul­ner­a­bil­i­ties of its for­eign in­spec­tion pro­gram. She said FDA is look­ing to hire 50 new in­spec­tors, but there are dif­fi­cul­ties.

“Even if the Agency suc­ceeds in hir­ing a new in­ves­ti­ga­tor, it can take 1.5 to 2 years of train­ing to bring them to a ful­ly pro­fi­cient lev­el,” Wood­cock said in her writ­ten tes­ti­mo­ny. With just 12 for­eign-based drug in­ves­ti­ga­tors cur­rent­ly, FDA says 90% of its for­eign in­spec­tions are con­duct­ed by US-based in­spec­tors.

Greg Walden (R-OR) ques­tioned Wood­cock and point­ed to a new Gov­ern­ment Ac­count­abil­i­ty Of­fice (GAO) re­port that found FDA is not com­plet­ing enough for­eign drug in­spec­tions, can­not hire enough in­spec­tors and that it pro­vides up to 12 weeks no­tice for some over­seas in­spec­tions. He al­so not­ed that FDA pre­vi­ous­ly con­duct­ed unan­nounced for­eign drug man­u­fac­tur­ing in­spec­tions but this ini­tia­tive was dis­con­tin­ued in 2015.

Wood­cock, mean­while, said more work is need­ed on the stan­dard­iza­tion of the in­spec­tion pro­gram. There is stan­dard­iza­tion for what in­spec­tors do and how they doc­u­ment it, she said, and “we’re chang­ing to a more mod­ern, stan­dard­ized process, which we’ve been able to com­plete for ster­ile prod­ucts.”

Mary Deni­gan-Macauley, di­rec­tor of health care at GAO, al­so tes­ti­fied on Tues­day that FDA rou­tine­ly gives for­eign drug man­u­fac­tur­ers sig­nif­i­cant ad­vanced no­tice of over­seas in­spec­tions, while the agency does not an­nounce many do­mes­tic in­spec­tions. But she said in­spec­tors face oth­er chal­lenges over­seas, with sin­gle in­spec­tors some­times cov­er­ing mul­ti­ple fa­cil­i­ties across acres of land. In­ves­ti­ga­tors al­so may have to use a man­u­fac­tur­er’s trans­la­tors and there can be un­cer­tain­ty about the ac­cu­ra­cy of cer­tain trans­la­tions.

Do­mes­tic and over­seas in­spec­tions need to be sim­i­lar, Deni­gan-Macauley said.

Wood­cock not­ed that for­eign com­pa­nies are no­ti­fied ahead of some in­spec­tions be­cause they usu­al­ly in­volve mul­ti­ple in­spec­tors com­ing over from the US, and the no­ti­fi­ca­tion is meant to en­sure those fa­cil­i­ties will be open.

Wood­cock al­so point­ed to plans at FDA to cre­ate in­cen­tives for man­u­fac­tur­ers to in­vest in prod­uct qual­i­ty. Part of such plans is to de­vel­op and im­ple­ment a rat­ing sys­tem for qual­i­ty man­age­ment ma­tu­ri­ty based on ob­jec­tive cri­te­ria. “Such a rat­ing sys­tem could en­able pur­chasers to com­pare dif­fer­ences in qual­i­ty and choose whether to re­ward more re­li­able man­u­fac­tur­ers fi­nan­cial­ly and with in­creased mar­ket share,” Wood­cock said in her writ­ten tes­ti­mo­ny.

On the is­sue of qual­i­ty, Rep. David McKin­ley (R-WV) asked Wood­cock if the gener­ic drug sup­ply is safe. And she as­sured him that FDA stands be­hind gener­ic drugs and that the agency has good safe­ty sys­tems in place. Com­pound­ed drugs, how­ev­er, is an area where prob­lems are oc­cur­ring, she added.


RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. 

Author

Zachary Brennan

managing editor, RAPS

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,100+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.