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 US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.