The shipment of your birthday present from distribution to delivery can be tracked. A sticker in the grocery store tells you where your pineapple was grown. A tag in your t-shirt says where it was made. Your new car lists where its component parts are from, and where it was assembled. But if you rely on anything from Tylenol to cancer treatment, you have less information about where those drugs came from and what path they took to get to you.
That’s just one startling fact in a new report released today by the Pew Health Group. After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs echoes the FDA’s recent call to overhaul the system that monitors imported drugs, and puts forward a number of recommendations to close those safety gaps.
“Consumers should be alarmed by the increasingly complex, globalized, and outsourced drug supply chain described in the After Heparin white paper,” Robert Restuccia of Community Catalyst said in a statement. Community Catalyst has teamed with Pew to advocate for many of the recommendations in the report, and leads the broad-based Alliance for a Safe Drug Supply.
“After Heparin shows that outsourcing is growing and is a business strategy for all types of prescription and over-the-counter drug producers,” he said. “As one major brand-name drug maker put it: ‘If we can buy it cheaper than we can make it then of course that’s what we’re going to do.’
And indeed, the numbers bear that out. When it comes to drugs, the U.S. import deficit on pharmaceuticals grew to $18 billion in 2008, and it is estimated that 80 percent of pharmaceutical ingredients and 40 percent of all finished drugs in the U.S. now come from overseas.
As we’ve written about here in recent weeks and months, there’s been surprisingly broad consensus from industry, regulators and the public that the system in place to monitor these imports is broken down and in urgent need of fixing. Last year, 94 percent of pharmaceutical executives surveyed said using foreign-made raw materials was risky. And in a different poll, the same percentage of likely voters wanted FDA to be able to recall unsafe or adulterated drugs, as it can for food. Only Congress can give the agency that power.
At the Pew After Heparin conference in Washington D.C. in March, which informed today’s report, we heard that everyone should be inspected by somebody—and that companies should be fully accountable for checking out factories and quality conditions prior to contracting with a supplier. We heard that in this fractured supply chain, industry actors needs to work with each other and with regulators to share information they may receive on potentially dangerous or counterfeited drugs, and that a uniform tracking system to help verify a drug’s path from factory to pharmacy is sorely needed, but will most likely require the force of law to achieve.
Recently, we talked with pharmaceutical expert Prabir Basu about the importance of investing in good manufacturing science – both on the design side, and ensuring that the tests used to detect false or substandard medications are state of the art.
We talked with California Board of Pharmacy Director Virginia Herold, who illustrated the importance of having a national tracking system for drugs that enter our homes and hospitals.
We heard from API manufacturer Brant Zell, who said the FDA has had its hands tied for years when it comes to fulfilling its mission to ensure the safety of foreign-made drugs. Zell said he thought that the heparin crisis in 2008 would be the straw that broke the camel’s back, and moved Congress to act. To date, that’s not been the case.
We’ve seen the FDA go before Congress to ask for the authorities and tools to do a better job of ensuring the quality and safety of drugs before they get to U.S. shores, and keeping ones that don’t meet quality standards out and off the shelves. So far, Congress has yet to act on those requests.
At a hearing last week, some in Congress again pledged to take action and pass a law that would guide the building of these industry quality rules and give the FDA the authorities it needs to oversee a terribly complex and global supply chain. Today’s report reminds us that there are enough gaps in the supply chain to exploit and economic incentives to do so that the clock is surely running on another heparin-like crisis. The time to act is now.
You can read the full report or watch a webcast of the March conference here.
–Kate Petersen, PostScript blogger