The other side of this activity is that there are organizations that are starting to coalesce around the supply chain and
share nonproprietary audit observations, so companies can feel more comfortable about where these products come from. There
are a few initiatives, but one of the better-known ones is Rx-360. For nonproprietary base chemicals that go into a pharmaceutical
or biopharmaceutical product, companies could rely on Rx-360 to qualify suppliers. A company can become a member and get audit
reports for facilities in China or India that it doesn't have the resources to get on its own.
Obviously, the regulatory environment is changing. Track-and-trace is coming out. There are a lot of pressures that are on
many different sides, and those pressures probably wouldn't be there except that we find things. There's not only adulteration
that occurs, but occasionally we test the products and find things that we didn't know were there. That's where a company
like BioReliance comes in, either in the final product or in process. There are organizations that test the material, and
once we find something that we didn't think was there before, we have to make sure we're mitigating the risk from that point
BioPharm: Didn't track-and-trace get voted down in the last version of the Prescrition Drug User Fee Act (PDUFA)?
Backer: It did. My understanding, though, is that there are members of Congress trying to bring it back again. Even though it's
been voted down, I'm not sure it's completely dead. From an industry perspective, it's a daunting prospect—if track-and-trace
had been signed and approved—as to how we would meet all of those standards. I think it's indicative of the fact that whether
it's done by us in industry, or whether it's done from a regulatory standpoint, we're going to have to understand our supply
BioPharm: For now, do you see initiatives like Rx-360 or other efforts by suppliers to come up with their own qualification as supporting
an eventual global track-and-trace initiative?
Backer: No, I don't know that I'd go that far. I think that industry is setting its own standards so that companies can meet a certain
level of confidence that our products are safe and effective. I don't know that we need track-and-trace legislation, but do
think that the industry is asking us as suppliers to do more.
Garrett: I think that's partially being driven by the regulators telling the industry that they want the ability to understand the
supply chain. I think a lot of the current initiatives have been driven by some of the public instances that have occurred,
not so much in the pharmaceutical industry, but, for instance, melamine in dog food. This was a huge issue obviously, because
it was a raw material that was not being monitored appropriately. That's something for which we really need to assess the
risk, and for a pharmaceutical supply chain it really presents an issue. Regulators have really begun to dig into this more.