While the FDA is typ­i­cal­ly known for its ever-ex­pand­ing hir­ing needs, thanks to an in­dus­try where top sci­en­tists can make dou­ble or triple in the pri­vate in­dus­try ver­sus the FDA, com­mis­sion­er Rob Califf on Thurs­day an­nounced two new lead­ers at the agency.

Johns Hop­kins’ Na­mand­jé Bum­pus will be the FDA’s new chief sci­en­tist, re­plac­ing Denise Hin­ton, who moved on in Oc­to­ber 2021 to ad­vise and sup­port the US Sur­geon Gen­er­al, and Hi­lary Marston, a White House se­nior pol­i­cy ad­vi­sor on Covid-19, will take over as chief med­ical of­fi­cer, which was a role pre­vi­ous­ly held by Janet Wood­cock.

Lu­ciana Bo­rio, ven­ture part­ner at ARCH and for­mer FDA act­ing chief sci­en­tist, told End­points News that she’s worked with Marston over the years “and am thrilled to see her in this po­si­tion. Na­mand­jé has a stel­lar rep­u­ta­tion. It is en­cour­ag­ing to see them at the FDA.”

.@Bum­pus­Lab and Dr. Marston rep­re­sent an im­pres­sive depth of ex­per­tise and bring di­verse per­spec­tives on sci­ence, agri­cul­ture, med­i­cine and pub­lic health.

— Dr. Robert M. Califf (@Dr­Califf_FDA) June 30, 2022

Bum­pus re­ceived her PhD in phar­ma­col­o­gy at the Uni­ver­si­ty of Michi­gan in 2007 and will join the FDA af­ter serv­ing as the di­rec­tor of the de­part­ment of phar­ma­col­o­gy and mol­e­c­u­lar sci­ences at Johns Hop­kins School of Med­i­cine. She’s al­so the pres­i­dent-elect of the Amer­i­can So­ci­ety for Phar­ma­col­o­gy & Ex­per­i­men­tal Ther­a­peu­tics.

Ac­cord­ing to Hop­kins, Bum­pus’ lab­o­ra­to­ry stud­ies drug me­tab­o­lism and us­es mass spec­trom­e­try and mol­e­c­u­lar phar­ma­col­o­gy-based ap­proach­es to in­ves­ti­gate the trans­for­ma­tion of clin­i­cal­ly used drugs by the cy­tochromes P450s, which are re­spon­si­ble for the me­tab­o­lism of an es­ti­mat­ed 75% of cur­rent­ly mar­ket­ed drugs.

Marston, mean­while, served re­cent­ly as the Na­tion­al Se­cu­ri­ty Coun­cil’s di­rec­tor of med­ical and biode­fense pre­pared­ness (for about one year) and pre­vi­ous­ly worked at the Na­tion­al In­sti­tutes of Al­ler­gy and In­fec­tious Dis­eases for about nine years.

Marston wrote a pre­scient per­spec­tive, along­side NI­AID di­rec­tor Tony Fau­ci, in the New Eng­land Jour­nal of Med­i­cine on the use of mon­o­clon­al an­ti­bod­ies for emerg­ing in­fec­tious dis­eases — two years be­fore the Covid pan­dem­ic.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.