President Trump’s choice to lead the FDA faced some questions, but not many, about drug pricing, according to various press reports about the Senate committee hearing Thursday regarding the nomination of Stephen Hahn, MD, FASTRO, the chief medical officer of MD Anderson Cancer Center.
President Trump’s choice to lead the FDA faced some questions, but not many, about drug pricing, according to various press reports about the Senate committee hearing Thursday regarding the nomination of Stephen Hahn, MD, FASTRO, the chief medical officer of MD Anderson Cancer Center.
The issue of vaping, and whether he supports a ban on flavored products, was the primary focus; he demurred from specifics, saying he would defer to the White House, where a policy is under review.
In prepared testimony before the Senate’s Committee on Health, Education Labor and Pensions (HELP), Hahn said that, if confirmed, “I promise to be guided by the core values of integrity and transparency, and I promise to put the interests of the American people first.” He also stressed his scientific background and said he respected Congress.
Also on Wednesday, the Biosimilars Forum released a statement stressing how previous FDA commissioners—most notably Scott Gottlieb, MD—promoted biosimilars.
Past leaders “have recognized the urgent need for educating stakeholders and accelerating biosimilar uptake, given that patients and the US health care system at large could save up to $150 billion over the next decade with increased biosimilar use. It is critical that the FDA continue combating misinformation and anti-competitive practices surrounding biosimilars, as well as reforming regulatory processes to allow for increased competition in the market,” the forum said.
Eleven of the 25 approved biosimilars are currently on the market, noted the forum, which is supporting various pieces of legislation to promote biosimilars.
Stat News reported that Hahn did acknowledge the issue of high drug prices in response to questions from Senator Mike Braun, R-Indiana.
“Not a week goes by when I see a patient who doesn’t comment on the stress—‘financial toxicity’ is how people refer to it—of high prescription drug prices,” said Hahn, who said he supports “moving forward with action that makes sense.”
In addition, Hahn appeared noncommittal on the administration’s idea to allow certain drug imports from Canada. He did not commit to supporting individual importation proposal, but said he would be open to examining whether drug importation could be conducted safely.
Senator Lamar Alexander, R-Tennessee, the committee chairman, said a vote on the nomination is expected in early December.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.