40% of the finished medicines and 80% of the active ingredients on US store shelves are manufactured overseas, and recent years have seen several high-profile cases of illness and death as a result of adulteration (replacing ingredients with cheap or even fake substitutes). A 2008 case involving heparin resulted in 81 deaths and nearly 800 severe illnesses.
A recent Pew study titled “After Heparin” focused on ways government regulators and pharmaceutical manufacturers could improve drug safety, partly by amending outmoded legislation that dates to the 1930s.
ExpatHealth.org spoke to Gabrielle Cosel, Project Manager for the Pew Prescription Project, dedicated to reforming the supply and manufacture of medicines, including oversight of the US pharmaceutical supply.
Where are the real problem countries in terms of unsafe drugs? I know the report mentions China specifically.
The report does have a number of examples from China, however we don’t really focus on one specific country. In general what we look at is movement and manufacturing overseas, specifically to emerging economies, where regulatory oversight may be less developed.
What’s the motive for tampering with or adulterating drugs in these countries?
It can be an honest mistake, negligence, or even a deliberate act such as heparin.
In the case of heparin there was one estimate that those responsible profited by between USD1-3 million. In that situation you had entities in the upstream manufacturing supply chain that realized they could sell a fake material as the real active ingredient. The fake was much, much cheaper to produce. In this case the motive was the opportunity for profit.
Does Europe face the same drug safety problems as the US?
We have heard from numerous experts and from participants in our March stakeholder meeting that this is a concern for Europe. Really it’s a global concern. The countries supplying active ingredients for the US are also supplying them to European countries. All evidence points to this not going to go away as an issue any time soon.
Yet if this is such a critical problem how is it the regulation has remained unchanged for so long?
It’s a complicated issue—on the food side a new food safety law was passed in the wake of a number of well-publicized food poisonings, salmonella being a notable one. It’s unfortunate that these events are drivers of action but it’s true to a degree. Then as you know we had the events of 2008 where people got sick and in some cases died after receiving contaminated heparin. We’re disappointed Congress hasn’t taken steps to address this yet.
Do Americans want greater regulation, especially in light of the small-government populism that’s cropped up in response to health reform?
We actually conducted a survey on this, and we were pleased to find consumers receptive to increasing the scope of government regulation. 94% were in favor of giving the FDA the power to recall a drug, for example—something it doesn’t currently have the power to do.
In order to fund better oversight, one proposal is pharmaceutical companies pay fees. This is already the case in Europe—how receptive are American companies to this?
We are really encouraged by the support from the generic drug sector and active ingredient manufacturers for new fees to cover increased FDA inspections. I think that’s a good sign. For the moment brand pharmaceutical companies have not given public support to new fees. They have expressed concern over the details, though they have not thrown them out as a possibility.
Industry fees are a way we can get funding where other budgetary appropriations might be more difficult.
Why the difference in positions between generic producers and brand name companies?
These producers have clearly expressed concerns not only regarding product safety, but also for a level playing field with growing competition outside the US.
How soon do you think we could see concrete legislation?
Our best thinking is a legislative solution would most likely move with the Prescription Drug User Fee Act (PDUFA) Re-authorization in 2012 (PDUFA requires drug manufacturers pay fees to help fund the drug approval process).
But again drug safety is a responsibility of both regulators and industry players. As we increase oversight the industry needs to be doing sufficient oversight of its supply chains, which are increasingly outsourced and globalized.
Gabrielle Cosel is project Manager of the Pew Prescription Project. She manages initiatives to promote consumer safety through reforms in the manufacture and marketing of medicines, including oversight of the U.S. pharmaceutical supply chain. Prior to joining Pew, Gabrielle worked on issues of pharmaceutical safety and appropriate prescribing for national advocacy organization Community Catalyst, and in grassroots development and capacity-building with the Fund for Public Interest Research in Cambridge, Massachusetts. She holds an MSc in Human Rights from the London School of Economics and a BA from Yale University.