The HHS is propos­ing to with­draw a Trump-era fi­nal rule that would have sun­set thou­sands of FDA and oth­er pub­lic health agency rules based on how long they’ve been in place.

The de­ci­sion fol­lows the fil­ing of a law­suit last March, in which sev­er­al non­prof­its al­leged: “The out­go­ing ad­min­is­tra­tion plant­ed a tick­ing time­bomb set to go off in five years un­less the HHS, be­gin­ning right now, de­votes an enor­mous amount of re­sources to an un­prece­dent­ed and in­fea­si­ble task.”

That task for the FDA, ac­cord­ing to the HHS, would be to re­view over 7,000 sec­tions of the CFR that were pro­mul­gat­ed by the agency and which are more than 10 years old, or would be­come more than 10 years old dur­ing the first five years the rule would be in ef­fect, rep­re­sent­ing over 95% of the FDA’s cur­rent reg­u­la­tions. The HHS al­so pre­vi­ous­ly de­layed the start of the Trump rule so that crit­i­cal re­sources weren’t di­vert­ed away from the pan­dem­ic to the re­view of fed­er­al reg­u­la­tions.

The HHS said Fri­day that, over­all, pulling the rule will save it more than $900 mil­lion over the next decade, and added sig­nif­i­cant de­tails on the ways in which for­mer HHS Sec­re­tary Alex Azar’s pre­vi­ous fi­nal rule was flawed:

Our think­ing is in­formed by a reeval­u­a­tion of the fac­tu­al premis­es and con­clu­sions in the SUN­SET fi­nal rule that are cen­tral to the De­part­ment’s analy­sis of the rule’s im­pli­ca­tions and ef­fects. In par­tic­u­lar, based on a re­analy­sis of the reg­u­la­to­ry im­pact of the rule, we now be­lieve that the rule like­ly rest­ed on a flawed un­der­stand­ing of the re­sources re­quired for this un­der­tak­ing, which im­pli­cates the like­li­hood that HHS reg­u­la­tions would ex­pire, and which in turn will re­quire the De­part­ment to make re­source al­lo­ca­tion de­ci­sions which could im­pede the De­part­ment’s abil­i­ty to car­ry out oth­er key pri­or­i­ties. That di­ver­sion of re­sources will like­ly im­pede ef­forts to adopt new rules to ad­dress na­tion­al pri­or­i­ties and ad­vance eq­ui­ty for all, in­clud­ing his­tor­i­cal­ly un­der­served and mar­gin­al­ized com­mu­ni­ties. It is there­fore po­ten­tial­ly in­con­sis­tent with the cur­rent Ad­min­is­tra­tion’s poli­cies that aim to em­pow­er agen­cies to use ap­pro­pri­ate tools to achieve those ends.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

We now know why Verve’s lead candidate was placed on hold last month by US regulators.

In an SEC filing, Verve laid out the FDA’s conditions for lifting the hold on its lead therapy, VERVE-101. That includes submitting preclinical data about potency differences in human versus non-human cells, risks of gene editing germline cells, and off-target analyses in non-hepatocyte cell types.

The FDA also wants clinical data from the ongoing Heart-1 trial, and to modify the trial protocol in the US to add additional contraceptive measures and increase the length of a staggering interval between the dosing of participants.