The US De­part­ment of Health and Hu­man Ser­vices’ (HHS) Of­fice of In­spec­tor Gen­er­al (OIG) on Mon­day re­leased the re­sults of tele­phone sur­vey of 323 hos­pi­tals across 46 states, the Dis­trict of Co­lum­bia and Puer­to Ri­co, find­ing “se­vere short­ages of test­ing sup­plies and ex­tend­ed waits for test re­sults.”

Hos­pi­tals re­port­ed that they were un­able to keep up with COVID-19 test­ing de­mands be­cause they lacked com­plete kits and/or the in­di­vid­ual com­po­nents and sup­plies need­ed to com­plete tests, in­clud­ing nasal swabs, vi­ral trans­fer me­dia and reagents used to de­tect the virus.

“One hos­pi­tal ad­min­is­tra­tor said that across the in­dus­try, ‘mil­lions [of tests] are need­ed, and we on­ly have hun­dreds.’ With­out ac­cess to need­ed test­ing ma­te­ri­als, some hos­pi­tals de­scribed di­vid­ing the me­dia in COVID-19 kits in half to dou­ble their ca­pac­i­ty and re­sort­ing to us­ing the trans­fer me­dia in flu and strep kits to pro­vide test­ing,” the re­port says.

The re­port comes as Pres­i­dent Don­ald Trump said last week, on a call with gov­er­nors: “I haven’t heard about test­ing be­ing a prob­lem.”

In ad­di­tion to the short­ages of the tests, hos­pi­tals re­port­ed fre­quent­ly wait­ing sev­en days or longer for test re­sults, and when pa­tient stays were ex­tend­ed while await­ing their re­sults, bed avail­abil­i­ty be­comes strained, as do per­son­al pro­tec­tive equip­ment (PPE) sup­plies and staffing.

“Hos­pi­tals’ re­liance on ex­ter­nal lab­o­ra­to­ries con­tributed to de­lays, par­tic­u­lar­ly as these lab­o­ra­to­ries be­came over­whelmed with tests to process from around the State or coun­try,” the re­port finds.

The sur­vey, con­duct­ed 23-27 March, al­so found hos­pi­tals re­port­ing “wide­spread short­ages” of PPE that put staff and pa­tients at risk. Oth­er sup­plies are in short­age too, such as in­tra­venous ther­a­py (IV) poles, med­ical gas, linens, toi­let pa­per and food, the re­port says. Oth­ers re­port­ed short­ages of no-touch in­frared ther­mome­ters, dis­in­fec­tants and clean­ing sup­plies.

As for ven­ti­la­tors, the sur­vey says that hos­pi­tals “re­port­ed an un­cer­tain sup­ply of stan­dard, full-fea­ture ven­ti­la­tors and in some cas­es used al­ter­na­tives to sup­port pa­tients, in­clud­ing adapt­ing anes­the­sia ma­chines and us­ing sin­gle-use emer­gency trans­port ven­ti­la­tors. Hos­pi­tals an­tic­i­pat­ed that ven­ti­la­tor short­ages would pose dif­fi­cult de­ci­sions about eth­i­cal al­lo­ca­tion and li­a­bil­i­ty, al­though at the time of our sur­vey no hos­pi­tal re­port­ed lim­it­ing ven­ti­la­tor use.”

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. Click here for more in­for­ma­tion.

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Moderna CEO Stéphane Bancel faced a barrage of questions from the Senate health committee on Wednesday but emerged mostly unscathed as he defended the quadrupling of the price of the company’s blockbuster Covid-19 vaccine in the US, from about $26 per dose to $130 per dose.

What’s behind that rise in price, many senators on both sides of the aisle questioned, and Bancel offered a variety of reasons. First and foremost, the company is expecting a 90% reduction in demand for its vaccine next fall, when the FDA is likely to roll out another booster campaign to fight Covid-19.

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.