The FDA on Thurs­day raised fresh qual­i­ty con­cerns about Emer­gent BioSo­lu­tions’ man­u­fac­tur­ing site in Bal­ti­more, which has more re­cent­ly been tak­en over by J&J af­ter an er­ror caused the site to dis­card about 15 mil­lion dos­es of the com­pa­ny’s vac­cine last month.

Ac­cord­ing to a Form 483 is­sued to the con­tract test­ing lab last April, fol­low­ing a 7-day in­spec­tion and just re­leased by the FDA, Emer­gent’s qual­i­ty unit failed to en­sure some very ba­sic, fun­da­men­tal ac­tiv­i­ties, like that staff couldn’t just delete or ma­nip­u­late elec­tron­ic da­ta, and the re­spon­si­bil­i­ties and pro­ce­dures for the qual­i­ty unit were not in writ­ing or ful­ly fol­lowed, FDA said.

“At the time of this in­spec­tion, no in­ves­ti­ga­tions had been per­formed to as­sess the im­pact of the da­ta dele­tions, mod­i­fi­ca­tions or the fail­ure to re­view sys­tem au­dit trails on drug sub­stance and drug prod­uct an­a­lyzed un­til ap­prox­i­mate­ly, De­cem­ber 2019,” the Form 483 signed by FDA in­ves­ti­ga­tor Mar­celli­nus Dor­dunoo says.

What’s more, the 483 high­lights the site’s in­abil­i­ty to pre­vent mix-ups of in­gre­di­ents or con­t­a­m­i­na­tion. The site’s mix-up of J&J and As­traZeneca drug sub­stance is what caused the mil­lions of dos­es to be thrown out.

“Sep­a­rate or de­fined ar­eas to pre­vent con­t­a­m­i­na­tion or mix-ups are de­fi­cient re­gard­ing op­er­a­tions re­lat­ed to the hold­ing of re­ject­ed com­po­nents be­fore dis­po­si­tion,” FDA said.

The com­pa­ny’s com­put­ers al­so did not pre­vent users from chang­ing the sys­tem date and time, mean­ing they could al­ter pre­vi­ous work as though they were work­ing in re­al time.

“Dur­ing the bio­chem­istry lab­o­ra­to­ry walk-through, it was ob­served that the present time-zone and sub­se­quent­ly, the date and time was able to be mod­i­fied,” FDA notes. The agency al­so found em­ploy­ees work­ing in the site’s bio­chem­istry lab who were not doc­u­ment­ed as be­ing trained on the firm’s writ­ten pro­ce­dures or test meth­ods.

An­oth­er ob­ser­va­tion notes that sam­ple iden­ti­fi­ca­tion num­bers “were ob­served to be man­u­al­ly cor­rect­ed, mul­ti­ple days af­ter da­ta ac­qui­si­tion” and the com­pa­ny did not per­form an in­ves­ti­ga­tion.

The Form 483 of­fers a peek be­hind the cur­tain on a site that has gar­nered lots of re­cent neg­a­tive at­ten­tion. Last Sat­ur­day, As­traZeneca, un­der the di­rec­tion of the US gov­ern­ment, an­nounced that it will re­lo­cate pro­duc­tion of its vac­cine drug sub­stance from the Emer­gent fa­cil­i­ty, but has yet to an­nounce a new site. No­vavax al­so pre­vi­ous­ly re­lo­cat­ed pro­duc­tion of its vac­cine from Emer­gent to Fu­ji­film.

An­oth­er out­side re­port on the site from last June, first ex­plained in de­tail by the New York Times, not­ed the fac­to­ry’s prob­lems “will re­quire sig­nif­i­cant ef­fort,” and the com­pa­ny “will have to be mon­i­tored close­ly.”

An Emer­gent spokesper­son said in a state­ment, “We have worked and con­tin­ue to work close­ly with the fed­er­al gov­ern­ment in sup­port of the COVID re­sponse. These FDA ob­ser­va­tions were ad­dressed and re­viewed in de­tail with FDA dur­ing their re­cent site vis­its in Sep­tem­ber 2020 and Feb­ru­ary 2021.”

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

The current monkeypox outbreak is now at a phase where some governments are approaching a point of concern, at least enough to start stockpiling vaccines.

In response, at least one government is placing its order with vaccine manufacturer Bavarian Nordic to secure sufficient supply for vaccinating individuals. According to the company, it has inked a supply contract with an undisclosed country for the company’s smallpox vaccine, called Jynneos. The aim is to ensure there will be enough supply to meet the undisclosed country’s requirements for vaccinating individuals at risk for monkeypox in the short to medium term. The vaccine is approved for use against monkeypox by the FDA and Health Canada.

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.