SACRAMENTO — News of as many as 19 deaths in the United States linked to contaminated blood thinner heparin from China has generated new concerns about how to keep bad drugs from finding their way into the marketplace.
But if California's 5-year-old effort to fight counterfeit drugs is a guide, the task may be tougher than it looks.
The pharmaceutical industry has repeatedly balked at implementation of the state's first-in-the-nation law approved in 2004 that would require manufacturers and retail pharmacies to create an electronic system to record a drug's journey from factory to patient.
The system was to be in place by Jan. 1, 2007, but the California Legislature in 2006 extended the deadline until next January. Today, the state Board of Pharmacy will consider another extension -- this time until 2011.
Big pharmaceutical companies, drug wholesalers and retail pharmacy chains say they can't meet California's Jan. 1 deadline and are asking for more time. Various industry associations have begun a quiet, coordinated campaign to promote the extension, hiring lobbyists and both Republican and Democratic-oriented firms that specialize in political strategy and media.
But state regulators say they're worried that further delays could endanger public health. "In 2011, they'll want 2013. In 2013, they'll want 2015," said state board member Stan Goldenberg, a Los Angeles pharmacist. "They'll keep the ball in the air until something bad happens." He said, "They're playing Russian roulette with the consumers of California."
The board, Goldenberg said, wants to be proactive.
"We are desperately seeking cooperation from the pharmaceutical industry," he said. "But we are not getting their cooperation" except for certain smaller manufacturers.
Stronger regulation is overdue, said Virginia Herold, executive officer of the pharmacy board. "We've learned that we cannot trust the supply train, and there are bad players."
The U.S. Food and Drug Administration has also had no luck implementing a national system to fight counterfeit drugs.
FDA spokesman Christopher Kelly acknowledged that the agency has run into a number of legal and administrative delays in instituting its own rules over the last 20 years. The FDA, he said, "supports California's efforts to further secure the drug supply chain."
