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.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.