FDA Policy/General

House Appropriators Approve $341 Million FDA Boost for 2023

The House Appropriations Committee 6/23 voted 31 to 26 to approve an FDA spending bill for fiscal year 2023 that will boost the agency’s discretionary funding by $341 million (10%) for a total of $3.645 billion. The bill provides a “targeted increase of $64 million for the opioid crisis, medical supply chain surveillance, drug safety surveillance and oversight, and increasing and strengthening in-person inspections of foreign drug manufacturers in India,” a committee release says. “It also includes a $77 million increase to better avoid or more quickly respond to food outbreaks, improve the animal food inspection system, and address heavy metals in baby food.”

The committee also released a report directing some FDA activities for FY 2023. These include:

The committee urges FDA to continue examining past drug approvals with identified pharmacogenomic safety issues and develop strategies that may mitigate risks of adverse drug events and reduce health
The committee encourages the agency to increase efforts to make Alzheimer’s clinical trials more inclusive, innovative, and conduct necessary outreach to underrepresented populations.
The committee says research suggests that therapies that combine cellular products and other cancer drugs may prove more effective for some patients, including those who do not benefit from single-drug treatments. These combination treatments increase the complexity of trial designs. Therefore, the committee urges FDA to work with and provide guidance to industry on how to standardize potency testing requirements for cellular therapies.
The committee notes the increased adoption of cloud-based technologies by FDA-regulated companies, the innovations facilitated through the cloud for improved product development, and the value of additional guidance on the use of the cloud throughout the product lifecycle.
The committee requests a briefing on how the agency determines conflicts of interest for third-party contractors hired to assist in the development of regulatory
The committee urges the agency to consider ways in which the Rx-to-OTC switch pathway could be modernized to increase its effectiveness for consumers.
The committee encourages CDER to utilize artificial intelligence and machine learning to enhance the review process for drug repurposing candidates by leveraging automated data collection, integration, and advanced statistical methods.
The committee urges FDA to finalize its over-the-counter hearing aid category final rule as expeditiously as possible.

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