Nei­ther Janet Wood­cock nor Joshua Sharf­stein is like­ly to be nom­i­nat­ed as the per­ma­nent FDA com­mis­sion­er, Steve Us­din at Bio­Cen­tu­ry re­ports.

Janet Wood­cock

The White House is look­ing for al­ter­na­tives to Wood­cock, the act­ing chief and long­time CDER di­rec­tor, af­ter op­po­si­tion from sev­er­al De­mo­c­ra­t­ic sen­a­tors who are call­ing on oth­ers to block her nom­i­na­tion if her name is put forth, ac­cord­ing to Us­din. Sharf­stein, the for­mer prin­ci­pal deputy FDA com­mis­sion­er and cur­rent Johns Hop­kins pro­fes­sor, is out of the run­ning al­to­geth­er.

As the va­can­cy at the helm of an agency tasked with over­see­ing the de­vel­op­ment and re­view of Covid-19 vac­cines be­came more con­spic­u­ous by the day — prompt­ing the New York Times to ask, “Who will be the next FDA chief?” — dis­tinct camps had formed around the two lead­ing can­di­dates.

Wood­cock earned plau­dits ear­ly from pa­tient ad­vo­ca­cy or­ga­ni­za­tions and bio­phar­ma­ceu­ti­cal com­pa­nies, the same groups that have spo­ken out against Sharf­stein for lack of ex­pe­ri­ence.

Joshua Sharf­stein

But there was a par­tic­u­lar group of ac­tivists who made their dis­dain for Wood­cock clear: those fight­ing the opi­oid abuse epi­dem­ic. And they be­lieve Wood­cock should be held re­spon­si­ble for “one of the worst reg­u­la­to­ry agency fail­ures in U.S. his­to­ry,” not on­ly over­see­ing but de­fend­ing “harm­ful opi­oid de­ci­sions.”

Sen­a­tors from some of states worst hit by the opi­oid cri­sis were re­port­ed to be her fiercest op­po­nents, in­clud­ing Sen­a­tors Mag­gie Has­san from New Hamp­shire, Ed Markey from Mass­a­chu­setts and Joe Manchin from West Vir­ginia.

Less pub­li­cized, per­haps, was the harsh cri­tique that some in­dus­try in­sid­ers re­served for Wood­cock over what they per­ceived as the loos­en­ing of the FDA’s reg­u­la­to­ry stan­dards, man­i­fest­ed in her de­ci­sion to over­rule FDA staffers and ap­prove Sarep­ta’s eteplirsen with­out clin­i­cal proof that their Duchenne mus­cu­lar dy­s­tro­phy drug works.

In a re­cent let­ter to Pub­lic Cit­i­zen, Wood­cock shut down the watch­dog’s pro­pos­al of a fire­wall be­tween reg­u­la­tors and drug com­pa­nies, ar­gu­ing it would un­nec­es­sar­i­ly “re­duce the ef­fi­cien­cy of FDA’s re­view process and cause de­lays in drug de­vel­op­ment.”

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

The FDA on Monday said it updated its recommendations for the clinical development of new antibacterial drugs, and thanks to a new clutch of drugs, sponsors will have to conduct noninferiority trials that include subjects with infections caused by certain drug-resistant organisms because an effective active control can be provided.

The guidance, which is likely to be released within the next day or so, builds on a 2017 document and specifies what noninferiority trial designs may be used “with a wider NI margin,” including cases in which the trial population is enriched for subjects with infections caused by certain drug-resistant organisms, FDA said.

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Bristol Myers Squibb is bringing new life to a chemotherapy drug from the old Celgene pipeline as it touts another approval in a rare form of blood cancer affecting young children.

The FDA on Friday approved Vidaza (chemically known as azacitidine) for pediatric patients 1 month and older with newly diagnosed juvenile myelomonocytic leukemia (JMML). The new indication marks the first approval for Vidaza in more than a decade, though it’s commonly used to treat acute myeloid leukemia and myelodysplastic syndromes (MDS).

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.