Drugs

FDA Blocks Lawmakers from Attending Cancer Drug Meeting

In the wake of CDER director Richard Pazdur’s abrupt resignation, reportedly over concerns of growing politicization at the agency, a new report now finds that two Republican lawmakers were barred from attending a 12/3 FDA meeting concerning the potential expanded approval of ImmunityBio’s Anktiva (nogapendekin alfa inbakicept-pmln), an immunotherapy for treating bladder cancer developed by billionaire company owner Patrick Soon-Shiong, following internal opposition within the agency.

One of the invited lawmakers, Senator Ron Johnson (R-WI), confirmed that the meeting was intended to discuss Anktiva, according to Bloomberg. Documents reviewed by the news group show that FDA commissioner Marty Makary was aware of the invitations, although it remains unclear whether he approved them.

The move was uncharacteristic, as FDA’s drug approval process is designed to be guided by science rather than political influence. While not explicitly prohibited, lawmakers typically are not allowed to attend such meetings to prevent the appearance of political pressure. Florida Representative Neal Dunn was also slated to attend.

Senator Johnson said that lower-level FDA officials “forcefully” objected to his attendance, though he will receive a readout from the meeting and is exploring a follow-up meeting with Makary and Soon-Shiong, according to Bloomberg. Johnson, a long-time supporter of the Right to Try movement, said he wanted to ensure terminally ill patients have access to promising therapies.

Former FDA official Peter Lurie warned that allowing lawmakers at review meetings could compromise scientific independence and create pressure on agency employees to approve a drug, according to Bloomberg. Critics have also raised concerns about Makary’s initiative to expedite drug reviews that align with administration priorities, a program seen by some as a potential avenue for political influence in the approval process.

Anktiva, approved last year for certain bladder cancer patients, competes with therapies from Merck and Johnson & Johnson. ImmunityBio aims to expand its use for other cancers, including lung cancer. Analysts have cited potential $1 billion in additional revenue if approval is granted for broader indications, according to Bloomberg.

FDA previously sent ImmunityBio a “refusal to file” letter in May, signaling that its expansion application was not ready for review. Soon-Shiong has publicly pressed the agency through social media, interviews, and direct appeals, citing frustration over the delayed approval.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome