Did somebody say “drug importation?”
Didn’t think so.
According to the Pew Health Group, the FDA needs much more power to protect the U.S. supply of drugs as more and more are made in other countries.
The new study found that increased outsourcing of manufacturing, a complex and globalized supply chain, and criminals all help to create the potential for counterfeit or substandard drugs to reach patients.
Well, duh – but important to regularly reinforce.
“It is clear the FDA was set up to deal with a domestic industry,” Allan Coukell, the director of medical programs at Pew Health Group, told National Journal. “But drugs are increasingly manufactured globally and are outside of the oversight of the FDA. There is a real need to update legislation to reflect the realities of the industry.”
The FDA is bound by a 1938 law that only gives the agency the authority to inspect products manufactured in the United States. “There’s only so much the FDA can do under the current law,” FDA Office of Compliance Director Deborah Autor said in a statement.
As Peggy Hamburg said at a recent meeting of the Council on Foreign Relations:
* The new reality of food and drug regulation is that it’s global. In fact, it should be a topic for conversation at the next meeting of the G20.
* The recent crises in both food and drug safety will only repeat themselves unless regulatory agencies from around the world work in closer and more regular partnership.
* There is a responsibility on the part of the FDA and other more developed regulatory agencies around the world to help build “regulatory capacity” for those nation’s that want and need assistance.
* Part of a closer working relationship means a more regular and robust sharing of global intelligence on issues of counterfeiting.
* And lastly, “We can’t inspect our way out of this problem."
All good things – progressive things -- but, short of a regulatory Marshall Plan, things that will have to rely (at least initially) on personal relationships between senior officials at various regulatory agencies and a focus on what’s best for global public health writ large is convergent with what’s best for any given nation.
It’s not as easy as it sounds.
