Over the last decade, FDA com­mis­sion­ers have gen­er­al­ly steered clear from the nit­ty-grit­ty of drug ap­pli­ca­tions, the opin­ions of drug re­view staff, or try­ing to bend laws that pro­hib­it the agency from at­tempt­ing to in­flu­ence the price of drugs.

Com­mis­sion­er Mar­ty Makary, how­ev­er, has al­ready stretched many of those pri­or con­ven­tions. And on Thurs­day, speak­ing at the Milken In­sti­tute's Fu­ture of Health con­fer­ence, he laid out a more ex­pan­sive role for the of­fice that would in­volve him in de­ci­sions and de­tails that oth­er top lead­ers of the agency have his­tor­i­cal­ly avoid­ed.

"We have to chal­lenge deeply-held as­sump­tions," Makary said at the event. "If you don't care about the op­er­a­tions of the agency or the im­pact you can have, the job is very easy. You can just show up at cock­tail re­cep­tions."

Since Pres­i­dent Don­ald Trump be­gan his em­phat­ic push to re­duce drug prices, a loom­ing ques­tion has been how low he could bring down the price of weight loss drugs that have sky­rock­et­ed in use.

The an­swer came on Thurs­day.

The White House un­veiled mul­ti­fac­eted deals with Eli Lil­ly and No­vo Nordisk, se­cur­ing dis­counts for their megablock­buster GLP-1 drugs in ex­change for Medicare cov­er­age. Ad­min­is­tra­tion of­fi­cials said the av­er­age month­ly price of both com­pa­nies' in­jectable and oral prod­ucts will be $350 per month. Lil­ly said in a sep­a­rate re­lease that it will of­fer the low­est dose of its Zep­bound mul­ti-dose in­jectable pens for $299 per month, with ad­di­tion­al dos­es at $449 per month.

No­vo cur­rent­ly of­fers We­govy di­rect­ly to cash-pay­ing pa­tients for $499 per month. Lil­ly of­fers the start­ing dose of Zep­bound for $349 per month, with all oth­er dos­es climb­ing to $499.

Eli Lil­ly’s oral obe­si­ty pill or­for­glipron was among the next six drugs to win the FDA's Na­tion­al Pri­or­i­ty Vouch­er, of­fer­ing the GLP-1 drug can­di­date a path to po­ten­tial ap­proval in as lit­tle as one month.

The FDA on Thurs­day un­veiled the batch of re­cip­i­ents un­der the new vouch­er pro­gram, which aims to sig­nif­i­cant­ly short­en the typ­i­cal 10 to 12-month re­view times.

The sec­ond batch, fol­low­ing Oc­to­ber's roll­out of the first nine vouch­ers, will go to:

Ei­sai said it’s plan­ning a rolling FDA sub­mis­sion next month to ex­pand the use of its Bio­gen-part­nered sub­cu­ta­neous Alzheimer’s treat­ment, the lat­est ef­fort to stoke the com­pa­nies’ ri­val­ry with Eli Lil­ly.

Leqem­bi was first ap­proved in 2023 for bi-week­ly IV ad­min­is­tra­tion, then won ap­proval in a new for­mu­la­tion this year that can be dosed week­ly at home via an au­toin­jec­tor. The lat­est ver­sion, dubbed Leqem­bi Iq­lik, is on­ly avail­able as a main­te­nance ther­a­py for pa­tients who have com­plet­ed 18 months of ini­tial in­fu­sions.

But ex­ec­u­tives said Wednes­day that they are hop­ing for an­oth­er ap­proval as ear­ly as the first quar­ter of Japan’s fis­cal 20