Patient safety demands drug quality controls and government oversight—from China and India to Framingham, MA CompoundersThursday, October 25th, 2012
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