A Q&A, by Angie Drakulich
In July 2010, the US Food and Drug Administration issued an enforcement strategy document signed by the heads of the key agency
centers and offices. The strategy document states, "...some regulated entities will disregard even the clearest regulations..."
and that, "All FDA components are committed to swift, aggressive enforcement actions to protect the public health." Since
then, industry has been uncertain of exactly what FDA has planned and how enforcement actions may or may not change. Pharmaceutical Technology talked to Rick Friedman, director of the Division of Manufacturing and Product Quality (DMPQ) within the FDA's Center for
Drug Evaluation and Research, Office of Compliance, to get a better sense of the agency's thinking on enforcement, quality,
and corporate responsibility.
PharmTech: In general, what changes should industry expect with regard to enforcement actions? Do you anticipate any new types of enforcement
authorities/activities to be approved by Congress in the future?
Friedman: FDA will continue to pursue swift, aggressive, and effective enforcement to ensure consumers have access to safe, effective,
and quality drugs. FDA expects to increase the number of risk-based surveillance inspections of certain drug manufacturing
sites around the world, including those that make over-the-counter finished products. At this time, I cannot predict the legislative
timeframe for modernizing the Food, Drug, and Cosmetic Act to allow more effective regulation of imported drugs.
PharmTech: DMPQ, and FDA overall, is very involved with the International Conference on Harmonization's Quality Implementation Working
Group (IWG) initiatives regarding quality systems and risk management. Now that the ICH IWG workshops are complete, do you
think industry has a better sense of how to address and use the harmonized principles in its daily manufacturing? Also, what
is the agency's goal in this area? For example, it's been noted that FDA officials and reviewers/inspectors are also on a
learning curve when it comes to the ICH quality guidelines and how to implement them.
Friedman: The ICH IWG workshops were well-attended and promoted an understanding of the harmonized Q8-Q9-Q10 guidelines. Both regulators
and industry attended these conferences to improve mutual understanding of an integral set of recommendations on development,
risk management, and quality systems. FDA's ultimate goal for these guidance documents is to promote innovation and improve
the quality assurance of pharmaceuticals for consumer use. We have made gradual progress toward cultivating an environment
in which firms promptly identify and correct manufacturing deficiencies that may occur during the manufacturing life cycle.
More training and interaction will help to promote awareness of the Q8–Q9–Q10 concepts, and continue to clarify terminology
and expectations. With better understanding by both industry and regulators of the opportunities presented by the modern quality
system, I think we will see broader implementation.
PharmTech: Agency officials have increasingly noted "corporate responsibility" in various public statements and conferences during the
past year. Can you explain why this issue is important, and to what extent the agency is willing to go to uphold corporate
Friedman: Expecting corporations and their management to be accountable for the quality of the drugs they produce is not a new policy.
Since the 1975 Park decision, courts have recognized that individuals who manage businesses that make and sell FDA-regulated
products have an affirmative legal duty to ensure the safety of their products. Because corporate executives are in the position
to prevent or correct drug quality problems, it is only logical that they are the ones ultimately held responsible if their
firm produces poor quality drug products.
PharmTech: Since the agency has turned up the volume, so to speak, on its enforcement approach, has DMPQ seen any change thus far in
industry feedback with regard to product quality and compliance?
Friedman: Industry is aware that FDA is placing more emphasis on swift and aggressive enforcement actions and encouraging modern quality
systems and PAT approaches. While the results are only anecdotal at this point, we have seen some very promising developments.
It will take some time before we can readily measure the overall trends.