Batch Testing Of All Imported Drugs Floated At House Appropriations Hearing

While food oversight dominated lawmakers' attention, Republicans and Democrats were united on need to onshore more drug manufacturing to the US as FDA Commissioner Robert Califf testified about the agency’s fiscal year 2024 budget request.

Califf testimony at House Appropriations
FDA Commissioner Robert Califf testified on the agency’s fiscal year 2024 budget request • Source: House Appropriations Committee

Batch testing of every imported drug to ensure purity and skirt some of the difficulties of conducting international inspections was raised by the chair of the House appropriations subcommittee that oversees the US Food and Drug Administration funding at a 29 March hearing on the agency’s fiscal year 2024 budget.

“If we were worried about imported drugs …why wouldn’t we as Congress authorize a scheme where every imported drug actually has to be batch tested by an independent FDA-approved lab?”...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

US FDA Meeting Drought Ends … With A Vengeance

 

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

More from Agency Leadership

US FDA Meeting Drought Ends … With A Vengeance

 

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 

FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.