Last week bipartisan legislation was introduced, ostensibly aimed at drug safety, called the Pharmaceutical Market Access and Drug Safety Act of 2007. Does it really deal with drug safety? Nope. It is almost entirely about the importation of drugs from Canada and other countries.
The bill does nothing to plug the leaky supply chain that we have here that allows drugs to be swapped among the thousands of secondary wholesalers like pork belly futures. Indeed, the requirements of pedigrees for pharmaceuticals (a list of prior owners) has still not been fully implemented despite being authorized by Congress in 1987.
There is nothing in the bill about the most basic of safety issues, such as increased criminal penalties for counterfeiters, mandating pedigrees back to the manufacturer, and funding for the F.D.A. so that they can actually do random testing of drugs in the marketplace, recall them when needed, and do proper investigations.
Before Congress tries to deal with foreign drug supply systems, it should get a grip on our own, and enact Tim Fagan’s Law, which came about as a result of domestic counterfeiting.
More on the subject can be found at:
- Jane Jarvan’s Health Law Update;
- Adam Fein’s Drug Channels; and
- My own Counterfeit Drug Resource Page (for background information on counterfeiting).