Af­ter an in­spec­tion in Feb­ru­ary, the FDA has re­vealed con­cern­ing ob­ser­va­tions at a man­u­fac­tur­ing fa­cil­i­ty be­long­ing to Rentschler Bio­phar­ma in Ger­many.

The fa­cil­i­ty, a drug sub­stance man­u­fac­tur­ing site in the small south­ern Ger­man city of Laupheim, had nine ob­ser­va­tions not­ed by FDA in­spec­tors.

The first ob­ser­va­tion not­ed that the sim­u­lat­ed fill process had no RPM spec­i­fi­ca­tion for the pump and no doc­u­men­ta­tion for RPM set­tings dur­ing drug sub­stance dis­pens­ing to be avoid­ed. The process is al­so not con­trolled to an es­tab­lished spec­i­fi­ca­tion.

The in­spec­tion al­so found two redact­ed pieces of equip­ment hav­ing rings of dis­col­oration be­low the top of the as­sem­bly, with no root cause in­di­cat­ed and no for­mal risk as­sess­ment or cor­rec­tive ac­tion to ad­dress the dis­col­oration.

Lab­o­ra­to­ry pro­ce­dures or test­ing to as­sure com­pli­ance with es­tab­lished spec­i­fi­ca­tions and stan­dards are not avail­able, FDA said. Equip­ment and fa­cil­i­ty sys­tems in sup­port of man­u­fac­tur­ing were al­so not ad­e­quate­ly val­i­dat­ed.

The FDA found that re­ject­ed ma­te­ri­als are not al­ways con­trolled to pre­vent their unau­tho­rized use and re­ject­ed ma­te­ri­als were not al­ways con­trolled un­der quar­an­tine.

The com­pa­ny al­so failed to es­tab­lish an ad­e­quate sys­tem for mon­i­tor­ing en­vi­ron­men­tal con­di­tions of crit­i­cal process equip­ment, fa­cil­i­ties and equip­ment in sup­port of man­u­fac­ture.

This comes at a time when Rentschler is mak­ing sev­er­al moves. The com­pa­ny ex­pand­ed its site in Mass­a­chu­setts last year, and has been look­ing to bump up its in­vest­ment in cell and gene ther­a­pies over the next five years. The Ger­man CD­MO opened a new site at the Cell and Gene Ther­a­py Cat­a­pult in the UK, al­low­ing Rentschler to es­tab­lish the man­u­fac­tur­ing of vi­ral vec­tors for clin­i­cal sup­ply.

Republican leaders of the House Committee on Energy & Commerce sent a five-page letter yesterday announcing an investigation into the ongoing drug shortages that have rankled the US during the pandemic and the FDA’s response to it.

The letter, signed by Chair Cathy McMorris Rodgers (R-WA), explains how shortages have become more common over the past decade, while pointing to a report from the National Academies of Science, Engineering and Medicine finding that drug shortages have been “on the rise” over the past several decades and are lasting longer, with new drug shortages in the US seeing a 30% increase from 2021 to 2022.

The US pharma giant Eli Lilly will be increasing its financial commitment to a manufacturing site in Ireland.

According to a release from Ireland’s Industrial Development Agency (IDA) on Monday, Lilly will be investing another $500 million in its manufacturing facility in Limerick, Ireland — bringing the total investment into the facility to approximately $1 billion.

In January of last year, Lilly announced it was placing a $446 million investment into the site to expand active pharmaceutical ingredient and monoclonal antibody production.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Republican members of Congress want FDA Commissioner Robert Califf and his agency to provide more information on the research FDA has funded that manipulates certain viruses like the SARS-CoV-2 virus — after the FDA confirmed that certain studies it funded involved viral manipulation, but in standard ways that are common in molecular biology.

The three-page letter, signed Monday by House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chairs Brett Guthrie (R-KY) and Morgan Griffith (R-VA), kicked things off by saying that the committee was looking into FDA’s oversight of “FDA-funded research that may pose significant biosafety or biosecurity risks.”

The FDA has scheduled or planned for three advisory committee meetings in May: one for an over-the-counter birth control pill, one for a nasal spray version of the EpiPen, and another for  Intarcia Therapeutics, which has all but completely folded already as a company.

Perrigo will bring its daily contraceptive, Opill, to the joint Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee on May 9 and 10 for its over-the-counter birth control application.