HHS Sec­re­tary Robert F. Kennedy Jr. de­fend­ed the FDA and Com­mis­sion­er Mar­ty Makary dur­ing a House hear­ing on Thurs­day morn­ing, say­ing that Makary is un­der a lot of pres­sure from the phar­ma in­dus­try.

Rep. Darin La­Hood (R-IL) ques­tioned Kennedy be­fore the House Ways and Means Com­mit­tee on Thurs­day re­gard­ing Makary's "mis­man­age­ment and bun­gled drug re­views," and say­ing that the FDA has "chilled in­vest­ments in life-sav­ing, in­no­v­a­tive cures, and that Chi­na is rapid­ly be­com­ing the re­cip­i­ent of those in­vest­ment dol­lars."

Kennedy pushed back on La­Hood's char­ac­ter­i­za­tion of Makary. He then in­cor­rect­ly point­ed to "record" new and gener­ic drug ap­provals last year. While Kennedy said the 91 first gener­ic ap­provals are a record, the FDA ap­proved 107 first gener­ic drugs in 2022. And ac­cord­ing to the FDA, 2018 is con­sid­ered the record year with the most ap­provals of new drugs.

Chi­na is "eat­ing our lunch" on new drug ap­provals and clin­i­cal tri­al starts, HHS Sec­re­tary Robert F. Kennedy Jr. told Con­gress Tues­day, while prais­ing the FDA's ac­tions so far.

"We are los­ing sci­en­tists, we're los­ing our IP, we're los­ing physi­cians, we're los­ing the best re­searchers, and we're go­ing to lose our biose­cu­ri­ty," Kennedy said in re­sponse to ques­tions from Rep. Brett Guthrie (R-KY) on Chi­nese in­no­va­tion.

As far as what HHS and the FDA can do to help, Kennedy said, "We're do­ing it right now. We are fast-track­ing ap­provals now in our coun­try at record lev­els. We are re­duc­ing the clin­i­cal tri­als from two tri­als to one tri­al, where ap­pro­pri­ate."

The FDA for the first time is fac­ing phar­ma-backed crit­i­cism of its new prac­tice of pub­licly re­leas­ing par­tial­ly redact­ed drug re­jec­tion let­ters.

The law firm Cov­ing­ton & Burl­ing, on be­half of an un­named phar­ma­ceu­ti­cal com­pa­ny client, filed a cit­i­zen pe­ti­tion dat­ed Mon­day with the FDA seek­ing to re­form the rules around the FDA's re­lease of in­for­ma­tion in the let­ters that may be com­pet­i­tive­ly sen­si­tive, and po­ten­tial­ly open the agency up for a law­suit. Cov­ing­ton did not re­spond to a re­quest for com­ment on which com­pa­ny filed the cit­i­zen pe­ti­tion.

"This com­pet­i­tive­ly sen­si­tive, non­pub­lic in­for­ma­tion that is be­ing re­leased un­der FDA’s new CRL prac­tice is pre­cise­ly the type of in­for­ma­tion that FDA is re­quired to pro­tect from dis­clo­sure un­der black-let­ter fed­er­al law," the cit­i­zen pe­ti­tion said.

Over the week­end, Pres­i­dent Don­ald Trump en­dorsed the po­ten­tial of psy­che­del­ic treat­ments and vowed to ex­pe­dite their re­search and de­vel­op­ment as reme­dies for se­vere men­tal health con­di­tions, a sem­i­nal mo­ment for a field long shunned by the US gov­ern­ment.

But how im­pact­ful his lat­est ex­ec­u­tive or­der is, and whether it ac­tu­al­ly ben­e­fits a ther­a­peu­tic class try­ing to break in­to main­stream pre­scrib­ing, re­mains to be seen.

The an­nounce­ment Sat­ur­day sent the world of psy­che­delics ablaze, in a good way, with com­pa­nies and re­searchers herald­ing Trump’s ac­tions as a break­through.

The ex­ec­u­tive or­der di­rects the FDA to has­ten re­view of psy­che­del­ic drug ap­pli­ca­tions us­ing the Com­mis­sion­er’s Na­tion­al Pri­or­i­ty Vouch­er (CN­PV) and to work with the Drug En­force­ment Ad­min­is­tra­tion to al­low el­i­gi­ble pa­tients to re­ceive the drugs un­der the Right to Try law.

The FDA threw its sup­port be­hind a dozen pep­tides, an­nounc­ing plans to re­clas­si­fy them, like­ly pre­sent­ing a huge mon­ey-mak­ing op­por­tu­ni­ty for what’s been a large­ly opaque mar­ket to date.

The agency said in a doc­u­ment post­ed Wednes­day that it plans to re­move the prod­ucts from Cat­e­go­ry 2, de­fined as a bulk drug sub­stance that rais­es sig­nif­i­cant safe­ty con­cerns. The de­ci­sion was an­nounced by HHS Sec­re­tary Robert F. Kennedy Jr. in a post on X, who wrote that “this ac­tion be­gins to re­store reg­u­lat­ed ac­cess and will im­me­di­ate­ly be­gin shift­ing de­mand away from the black mar­ket.”

It is not clear where the prod­ucts will be re­clas­si­fied, though there is on­ly one cat­e­go­ry that's more le­nient: Cat­e­go­ry 1. Bulk drug sub­stances in that cat­e­go­ry are ef­fec­tive­ly al­lowed to be mass pro­duced by com­pound­ing phar­ma­cies, be­cause the FDA has said it doesn’t in­tend to take ac­tions against phar­ma­cies that do so, con­tin­gent on them fol­low­ing oth­er reg­u­la­to­ry mea­sures.

The Cen­ters for Medicare and Med­ic­aid Ser­vices has de­layed a key pi­lot pro­gram fo­cused on Medicare cov­er­age for obe­si­ty med­ica­tions, af­ter in­s