Today's Wall Street Journal has a fascinating peek into the world of counterfeit drugs in China. (See China Government Cited in China Probe.) The article states:
"For years, China's pharmacies and hospitals have been plagued by low-quality and fake medicines made by local drug companies. Just last fall, an antibiotic made by a pharmaceutical company in Anhui province sickened dozens of people across China and killed at least 10, according to China's state-run Xinhua news agency.
Blame often falls on small drug makers that the government says skirt laws to turn a profit. Now, the man who ran China's State Food and Drug Administration until he stepped down in 2005 is at the center of a widening corruption scandal. The State Council, the country's cabinet, alleges that Zheng Xiaoyu, the agency's former head, accepted bribes from drug companies and abused his power, according to Xinhua."
Scary stuff. It makes me appreciate the relatively secure drug supply chain that we enjoy in America. If you're like me, you'll also wonder why Congress wants to infect our system by creating new gateways for counterfeits with importation legislation.
I suppose we should all be grateful that Senator Dorgan's bill leaves China off the list of approved countries, right? His importation website mildly states: "The bill allows U.S.–licensed pharmacies and drug wholesalers to import FDA–approved medications from Canada, Europe, Australia, New Zealand, and Japan..."
But if you bother to read the actual text of the inaccurately named S.242 Pharmaceutical Market Access and Drug Safety Act of 2007, you'll discover that the list of permitted countries includes any "member country of the European Union."
I get really worried when I look at list of member states, especially those added in the EU's 2004 enlargement. So I'm left wondering: How hard would it be for a drug made in China to pass through Latvia or Slovenia on its way to the US? Let's face it -- probably not too hard at all.
Re-read my post from last November on a scheme that put fake drugs from India into the hands of US consumers. (Of Spammers and Senators). Then ask yourself: why are politicians endangering public health by opening up diversion channels for criminals?
Adam--
ReplyDeleteAt this point, there might be some competition as to which Congressman can open the importation pipeline the widest. Ron Paul (R-TX) has a bill, HR 194, (adam, link is
http://thomas.loc.gov/cgi-bin/query/z?c110:H.R.194:
that restricts HHS/FDA from taking any action against "interstate sale of a prescription drug through an Internet site," provided that "applicable" state and federal rules were met. As we all know, unregulated websites are the single most-active source of fake or adulterated drugs entering the country. The relevant section of the bill is called the "Facilitation of Importation of Drugs," and assumes, I guess, that FDA can inspect/regulate drug distributors in cyberspace.
It's a long way from a bill to a law, of course, and Ron Paul, who advocates the abolishment of income tax and a return to the gold standard, represents something of fringe movement (I'm being polite). But still, how far can anti-industry sentiment go?
The Senate bill is identical to House bill H.R. 380.
ReplyDeleteThe bills expand the federal government's powers with regard to both individual U.S. states as well as foreign countries. In addition, track-and-trace is necessary but not sufficient for supply chain security. See Thank You for Buying Counterfeits Adding insult to injury is the fact that track-and-trace technology is not nearly as advanced as these bills imply.
I recall my Schoolhouse Rock well enough to know that these are not laws, but the level of bipartisan support and political rhetoric belies significant misunderstanding of drug distribution channels.
Adam