On December 1, 2023, AGG Food & Drug co-chair Alan Minsk was quoted in a Life Science Leader article titled “Executive Outlook: Converting Innovative Science Into Predictable Returns.”
The article discusses uncertainty around the timing of FDA’s foreign inspections and resulting drug shortages, which will likely continue to interrupt business plans in 2024.
“We’re seeing continued FDA Warning Letters to Indian and Chinese API manufacturers, which ultimately affects finished products, and drug sponsors,” said Alan. “An organization can do everything right, but if the manufacturing can’t be done properly, or there’s a delay in foreign inspections, that creates challenges.”
As drug shortages can cause real harm to patients needing a consistent supply of medication, Alan also notes that organizations able to fill a shortage-related gap are well positioned to work with the FDA on a solution.
“Organizations can go to the FDA and say, ‘How can we help to make certain products available, and can you expedite our application because of an ongoing drug shortage,’” he said.
Despite office reorganizations, foreign inspection logistical challenges, and ongoing post-COVID adjustments, Alan shares that FDA still manages to prioritize impactful product candidates and issue helpful guidance to industry.
Alan also addresses bad ads and the relatively quiet activity from FDA’s Office of Prescription Drug Promotion since 2020.
Alan said, “FDA will continue to focus on products with Risk Evaluation and Mitigation Strategies [REMS] programs or black box warnings, but I think that companies have gotten better generally” at following promotional guidelines; past enforcement letters have provided greater specificity regarding the agency’s thinking in various promotional channels, including social media.
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