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2 years ago-Biopharma Group
2 years ago-BioGenes GmbH

Hahn confirmed as FDA head, to lead agency as drug review process is tested

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The Senate confirmed Stephen Hahn as the next Food and Drug Administration commissioner in a 72-18 vote Thursday, setting up the agency to soon have a permanent successor to Scott Gottlieb, who left the post in April.Hahn’s swift confirmation garnered praise by former FDA commissioners, lawmakers and industry groups. President Donald Trump announced his intent to nominate the oncologist Nov. 1, and the HELP Committee passed his nomination to the Senate 18-5 on Dec. 3.Hahn will be tasked with leading an agency that oversees 20 cents of every dollar spent in the U.S. Since Gottlieb, it has been led on an acting basis by the National Cancer Institute’s Ned Sharpless and HHS Assistant Secretary for Health Brett Giroir.

Hahn is poised to the lead the agency through a critical period. While his approach to tobacco and e-cigarette regulations will be closely watched, he has yet to fully lay out an agenda on how he plans to follow up Gottlieb on regulating the drug industry.

Gottlieb left a mark on the agency by focusing on e-cigarettes, opioids and drug prices, amplified by a frequent Twitter presence and memorable call-outs of drugmakers for their “shenanigans” and “Kabuki drug pricing.”

Though he won broad support during his tenure, Gottlieb also faced challenges. A sprawling recall of contaminated heart drugs led to questions about the FDA’s ability to oversee drug manufacturing abroad, spurring agency leaders to push back.

Record levels of drug approvals, meanwhile, spurred criticism from some doctors and experts that the FDA now favors speed too heavily, allowing drugs to reach market despite uncertain efficacy.

Questions on approval rigor will likely only grow under Hahn’s watch. Just hours after Hahn was confirmed Thursday, the agency took the unusual step of reversing course and granting an accelerated approval to a Duchenne muscular dystrophy treatment it had rejected four months before.

An even tougher test could come under Hahn’s watch. Biogen has stated it plans to submit its Alzheimer’s drug aducanumab for regulatory approval on the basis of a controversial analysis of two late-stage studies that were initially judged unlikely to succeed and halted early.

A regulatory review would likely bring significant pressure from patients and politicians, given aducanumab could be the first approved disease-modifying treatment for a neurodegenerative condition that afflicts millions of Americans.

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