FDA Adopts New Strategies to Oversee Global Economy - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Adopts New Strategies to Oversee Global Economy
A Q&A with FDA Deputy Commissioner Deborah Autor.


Pharmaceutical Technology
Volume 36, Issue 7, pp. 26-34

PharmTech: Will regulatory collaborations address some of these issues?

Autor: I would like to make sure that we are being strategic and cohesive globally in addressing criminal threats to the drug supply. Whether it's counterfeiting or cargo theft or economically motivated adulteration, I think there's a real opportunity to make sure that we take a holistic look. We need to make sure that the civil side out there monitoring facilities and the criminal side catching criminals are talking so that we're able to both punish crime—and also prevent and detect crime by building stronger regulatory safeguards and by telling industry what the risk might be and how to be proactive in protecting itself from potential risks.

PharmTech: Another proposal is to do more to leverage third parties for conducting inspections. This has not been a big success at FDA so far, so is it still promising?

Autor: It is true that the agency hasn't always had perfect results in relying on private third parties for inspections, but I think that there is real potential there. We are further ahead in our exploration with respect to devices and foods, but I think we've got what we need to get there on the drug side as well. This approach creates some real challenges, and we need to be frank about those and to figure out how to overcome them.

For regulators, it's hard to let go and to let someone else help us. But given the realities of globalization, we just can't do it alone. If we can work with others, if we can let go of control to some extent, we will have many more resources at our disposal. We shouldn't walk into this blind to the downsides, but it is possible, and I believe we can get there.

PharmTech: Another recent report from the Institute of Medicine (IOM) recommended that FDA pursue 'mutual recognition' agreements of inspection findings. Is that a realistic approach?

Autor: I believe that we need to look for 'mutual reliance.' That means sufficient comfort with each other's standards to be willing to rely on work done by a counterpart. We don't necessarily need to go the whole way to mutual recognition agreements. I hope, over time, that regulatory standards globally will converge, something that is already happening. As we work together, we all learn from each other.

PharmTech: That IOM report also mentioned the Secure Supply Chain pilot program and greater use of low-cost technologies to oversee imports. What role can those play?

Autor: The Secure Supply Chain is a pilot project that aims to facilitate imports from companies and facilities where we have a certain level of assurance. It is in the process of moving forward and presents a risk-based concept: If you can know that certain imports are low risk, then you don't have to devote much time to them.

We also see opportunities to utilize more low-cost technologies in dealing with imports and supply chain security. One example is employing hand-held laboratory devices at the border. And in Africa there's use of a scratch-off number on a drug package that you can text in and find out if the drug is authentic. Manufacturers also are using barcode technology on brand name clothing or handbags and a call-in system to learn if the product is legitimate or not. I understand that certain large chain stores have RFID tags on underwear, so it seems that there's potential for pharmaceuticals.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
Source: Pharmaceutical Technology,
Click here