FDA Foreign Drug Establishment Inspections – Congressional Testimony

Subcommittees of the House Committee on Energy and Commerce heard testimony last week from the Government Accountability Office’s Mary Denigan-Macauley and from Janet Woodcock, Director of FDA’s Center of Drug Evaluation and Research, about the state of FDA’s foreign drug establishment inspection program.

Deborah L. Livornese “Testimony About FDA’s Foreign Drug Establishment Inspection Program: GAO and FDA See Things Differently but Both Would Like to See a Fuller Glass.” FDA Law Blog. 16-Dec-2019

Good summary of recent testimony on FDA inspections outside the USA, especially China and India.

Data Integrity and the Role of Guidances

Interesting piece over at FDALawBlog on the new data integrity guidance “New Data Integrity Guidance Imposes Significant Burdens, Yet FDA Claims It Does Not Regulate by Guidance.”

I find it interesting to read a different perspective. I tend to be a big fan of guidances (they always need work) as they help lay down how we can get better and improve. Being on the front line of regulatory inspections probably more than a group of lawyers, I recognize the differences in how guidances are treated differently than regulations, and how the agencies apply very long lead times on how inspections treat this material. And frankly, the 483s and Warning Letters we are seeing coming out of data integrity scare the beejeezus out of me. There is also a need for the FDA to ensure it’s thinking on matters is aligned with our European and rest-of-world counterparts, especially in this day of mutual recognition agreements.

Regulatory and administrative law is definitely continually evolving. It is important to be aware of a variety of perspectives  on the subject.