Observation: Hidden In The COVD Funding Bill Is Additional Funding For FDA
Hidden in the $42m are some interesting line items, like $7m for artificial intelligence and $9m to establish a knowledge management system. There is also $3.5m for unannounced foreign inspections. Historically, FDA has given foreign manufactures 3 to 6 months notice for an inspection. This pilot program was discussed in Senate hearings June 2020, but was mainly for drug manufactures (70% of all API drugs marketed in the US are manufactured outside the US - 19% in India 13% in China). In 2013, there was the India Pilot Program which allowed 'a couple days' inspections in India. This led to a 60% increase of OAI findings, but it was shut down in 2015.
Unofficially, but hopefully, with the additional funding, insiders in FDA are thinking beyond drugs and potentially expanding the program to some high-risk medical device manufacturers. Much of the funding will go to hiring vacancies at foreign FDA offices (China, India, & Latin America), which will all make for easier for both drug and device unannounced inspections.
F. David Rothkopf, MEDIcept President