Regulating your PET

by Carol Ko, Staff Writer | June 06, 2013
Peter Webner, vice president
business and clinical
development - Zevacor Molecular
From the June 2013 issue of HealthCare Business News magazine

Last year, the FDA implemented ANDA/NDA requirements for all PET drugs. Practically speaking, this shift required players in this market to undergo a fairly radical shift in their day-to-day operations.

DOTmed Business News asked Peter Webner, vice president of business and clinical development at Zevacor Molecular, for his take on how successfully manufacturers are adjusting.

DMBN: What are some of the barriers for players entering into the market now?

If you've filed your ANDAs, you can shorten the process by months, if not years. The barrier's gotten higher for manufacturers entering the market today. There's a lot more regulatory burden because now you're open to not only pharmacy, or NRC, you also have FDA oversight and routine inspections.
Now, you need to perform a much higher level of microbiological testing and surveillance. During the manufacturing process you have to monitor the environment and test for any microbial or fungal contamination.

The environment in which we manufacture has changed as well — it has to be a controlled environment. The difference is like switching from working in a lab environment to working in an OR environment — the standards have changed.

DMBN: What do you see as the challenges for the industry moving forward?

You can't legally distribute or use any FDA-cleared PET products until you have approval unless you submitted your NDA/ANDA by the June 2012 deadline, and your filing was accepted by the agency.

Part of the hurdle for new entrants is spending capital on a manufacturing facility, then having to wait for distribution approval.

The investment required ranges from $3.5 to $7 million depending on the scale of the facility. You also incur additional expense for more manpower, continued quality monitoring, and additional training and auditing.

Anything going into the product now needs a certificate of analysis, and we need to perform vendor audits on a regular basis. We need to qualify all of our vendors and validate their product to make sure they meet their published release and quality criteria. Before this, our operations were analogous to a hospital pharmacy: no hospital pharmacy would have a process to validate all the drugs, IV bags, and solutions they get, and that's how we used to operate. But now, we have to do all of that surveillance.

DMBN: What are some of the challenges in terms of hiring and training?

Before, you could hire pharmacy managers that wear multiple hats to oversee safety and quality. Now the workload is such that it is difficult for a single person to oversee all aspects of quality. Now, most manufacturers need to have a specifically designated manufacturing quality person or group.

In the past we've seen people starting off as couriers getting trained and promoted to other roles, on the manufacturing or quality side. They may have been trained adequately, but we've seen a couple of instances where the agency says, what is the person's educational background? It's bringing the level of employees that we're hiring for these positions higher and this brings up cost.

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