PharmTech: FDA has been successfully building its overseas presence for a couple of years to help train other national regulatory agencies
and to increase inspections of foreign facilities. There is still a lot of grumbling that overseas audits are more lenient
than domestic audits (e.g., companies outside of the US have advance notice of inspections, whereas US companies do not).
Do you agree with the characterization? What will FDA do to level the playing field?
Friedman: We do not agree with that characterization. Foreign inspections do pose their own unique challenges. FDA only has explicit
authority to take legal action on products in its jurisdiction (the United States). Although we do not have authority to seize
products in foreign commerce nor enjoin foreign firms, we can administratively block adulterated products from entering the
US by placing firms on import alert if we find significant violations during an inspection. This is a faster sanction than
seizure or injunction, and is a strong one.
PharmTech: There has been some talk of electronic inspections increasing—including at the ICH workshop in October 2010. Do you see this
model growing in the future and if so, what advantages might it offer for industry and for regulators?
Friedman: The inspection of a facility's conditions and practices are done on site. It is analogous to buying a house. You want to see
it before you buy it. Indeed, you even do a final walk-through. A manufacturing facility is extremely complex, and CGMP audits
require one to observe numerous manufacturing practices like sanitation (such as personal hygiene), state of repair of equipment,
whether personnel practices match what is written in SOPs and staff are qualified, contemporaneous completion of batch records,
whether operations are being supervised, laboratory conditions and controls, how a firm deals with deviations, etc. With that
said, we obtain and leverage electronic information on facility statuses quite routinely these days, particularly when collaborating
with our international regulatory counterparts.
PharmTech: Are there any major new guidances affecting drug manufacturing that industry should look for in 2011?
Friedman: We expect FDA's guidance on process validation will publish as final in 2011. In addition, CGMP regulations and guidance for
Positron Emission Tomography drugs will go into effect in December 2011. We are also working on other guidances that should
enhance industry's understanding of regulatory expectations regarding drug manufacturing and product quality.
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