Do you want your new prescription drugs to be made under last century's oversight? Like it or not, that's likely what you're getting -- or worse -- according to recent research from the Pew Health Group.
Increasingly, Americans' medicines are made overseas in place where the oversight isn't up to U.S. standards, according to the white paper, After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs.
That's troublesome: According to the Food and Drug Administration, an estimated 40% of finished drugs and 80% of active ingredients and bulk chemicals used in U.S.-made drugs come from abroad.
Pew's research finds that increased outsourcing of manufacturing, a complex and global supply chain, and criminal actors create the potential for counterfeit or substandard medicines to reach U.S. patients. For economic reasons, the migration of drug manufacturing abroad is likely to continue. At the same time, industry and government agencies have failed to adapt to the changing environment, says Pew.
"Today's prescriptions are being produced under last century's oversight," said Allan Coukell, director of medical programs at the Pew Health Group, in a prepared statement. "Compared with a decade ago, pharmaceutical supply lines stretch around the world and out to a complex web of suppliers. Regulators and industry must modernize supervision of the manufacturing process to ensure the drugs we consume are safe. The After Heparin white paper identifies links in the supply chain that government and business should strengthen," said Coukell.
Substandard or adulterated pharmaceutical materials from abroad have entered the U.S. on multiple occasions, reports Pew. In addition, the risks of domestic counterfeiting and diversion of stolen drugs are well documented. The white paper presents several case studies -- including incidents involving heparin, a blood thinner adulterated during its manufacture in China; counterfeit vials of the anemia drug Epogen; and stolen vials of insulin -- to illustrate the threats.
Some Possible Solutions
What potential fixes does Pew suggest for this ailing drug system?
Companies must take responsibility for the entire supply chain by: improving oversight of contract manufacturers and suppliers; ensuring documentation and transparency of incoming drug ingredients; and developing rigorous testing standards. Drug makers must audit suppliers on-site prior to engagement and institute supplier quality agreements. Company management must be held accounting for implementing these systems.
Congress should establish national standards and oversight of drug wholesalers and require the private sector to track and verify the authenticity of pharmaceuticals.
Increased overseas inspections by the FDA, along with the expanded use of third-party sources of information to supplement FDA inspections.
It's tough to argue against these fixes: No one wants to second guess whether their painkiller will kill more than just the pain.