We are shocked and distressed to learn of the 24 deaths and 328 illnesses caused by the meningitis-contaminated painkiller injections produced in a Massachusetts compounding pharmacy, the New England Compounding Center (NECC). Our thoughts are with the families of those patients and the 14,000 more who are waiting to learn if they were infected by their medical treatment. While the news continues to develop, we are still waiting to fully understand what went wrong, what the company should have done to prevent this, and what are the state and federal agencies with oversight responsibilities.

This tragedy reinforces our commitment to ensuring that all people have a right to trust the safety and purity of the medicines they take. As we have learned from advocating for the major drug manufacturing safety legislation passed this year by Congress, the pharmaceutical supply chain is extremely complicated. Now everyone is recognizing that compounding pharmacies are an important, additional link in that chain.

Weaknesses in the global supply chain became painfully apparent in 2007-2008 through another tragedy, when dozens of U.S. patients suffered adverse effects and some died after receiving heparin, a blood-thinner used in dialysis treatments that had been contaminated during its manufacturing in China. Many things contributed to that failure in the supply chain, including the increasingly globalized nature of pharmaceutical manufacturing and insufficient FDA resources and authority to manage it. For example, 80 percent of Active Pharmaceutical Ingredients used in drugs sold in the U.S. are produced overseas. And for a long time, the FDA has not had the resources to inspect all of these suppliers and finished manufacturing operations. Domestic plants were being inspected approximately once every two years, but foreign plants averaged once every nine years, and some were never inspected.

Fortunately, this summer, with broad support from advocates and many in industry, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) to address the problems that contributed to the heparin situation. FDASIA requires companies to implement robust “Good Manufacturing Processes,” other controls and transparency throughout the supply chain, from the raw materials to the finished products. It requires manufacturer and importer registration and risk-based inspections in both domestic and foreign plants, which should increase the frequency in foreign plants. There are new user fees for generic companies to support increased inspections, with a goal of parity between U.S. and foreign inspection rates. And there is much stronger enforcement and higher fines. While FDASIA has some weaknesses—FDA still does not have mandatory recall authority, a minimum schedule of inspections at all plants or protections for whistleblowers—the law is a huge step forward in ensuring safety of the drugs produced by registered manufacturers.

But compounding pharmacies like NECC appear to fall outside of FDASIA. They are licensed only to prepare specialized or modified drugs for individual patients with an individual prescription. Massachusetts has now ruled that NECC violated its license by selling in bulk, by acting as a typical manufacturer. For years NECC has carried out sophisticated marketing operations throughout the country, leading to big production increases and to the unfolding tragedy today. Yet compounding pharmacies have lobbied for a decade to avoid stronger regulation and as a result even more patients were potentially affected by their practices.

Ironically, compounding pharmacies have been helping to fill the gaps when drug shortages occur—and many of these shortages are a result of problems at domestic and overseas conventional drug manufacturers that have had to temporarily close plants or production lines. This is another sign FDASIA was long overdue, since company quality control systems and FDA regulation have not kept pace with the brave new world of globalized drug manufacturing. Small scale compounding pharmacies can legitimately help fill such gaps for the benefit of individual patients, although they too should be required to have strong quality assurance systems in place.

At this time there are many efforts being undertaken by state and federal lawmakers and regulators to identify precisely what legal authority currently exists for regulating compounding pharmacies and what additional oversight and resources are needed to ensure the safety of compounded drugs. We support the efforts of Congress, the FDA, state boards of pharmacy, pharmacy retailers, drug manufacturers, and other patient advocates in finding solutions to ensure the supply chain is strong and that Americans can again trust the medicine they rely on.

 – Anna Dunbar-Hester, Policy Analyst &
Marcia Hams, Prescription Access and Quality Program Director

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