The safety and integrity of the global drug supply chain stands among the FDA’s major proposed priorities for the next four years. We support this plan wholeheartedly, as the challenges of globalization have far-outstripped the FDA’s resources for inspections and quality monitoring, and thus the risk to consumers has been growing. We have seen many supply chain malfunctions of late, from fungus in antibiotic IV bags from India, to bacteria in over-the-counter children’s medications from Pennsylvania, to the tragic deaths in 2007 and 2008 from contaminated heparin, a blood-thinner produced in a Chinese factory and administered to American patients.

Our position is pretty simple. We believe Americans have a right to uncontaminated medications. The prescription and over-the-counter drugs we rely on to keep us healthy should contain the correct amount of active ingredients as stated on the box, should not contain any contaminants, and should not have been adulterated at some stage of manufacturing. The solution is not as simple, but with commitment from manufacturers and with FDA oversight as a safeguard, we can provide safe drugs to those in need. Additional information on our work on drug safety, including legislation that would enhance the FDA’s oversight authority and resources, can be found on our website.

The FDA’s report said it would shift its focus to prevention – stopping threats before they ever become a reality. To do this, the FDA will require more information about all phases of production and distribution, along with regulatory standards that foster corporate responsibility; more coordination among foreign, federal, and state entities; updated enforcement tools; increased inspections; and updated systems including Information Technology.

Community Catalyst and six other organizations jointly submitted comments in support of the FDA’s proposal for strengthening the safety and security of the global supply chain. These groups include:

  • The American College of Physicians
  • The American Federation of State, County and Municipal Employees (AFSCME)
  • The Bulk Pharmaceuticals Task Force
  • Consumers Advancing Patient Safety
  • Health Care for All (Massachusetts)
  • Our Bodies Ourselves
Our comments explained the importance of improving the global supply chain from the perspective of consumers, health care providers, and drug component manufacturers. You can read the comments here.

Also offering comments in strong support of the FDA plan were:

  • The Pew Health Group of the Pew Charitable Trusts
  • Consumers Union, the non-profit publisher of Consumer Reports
  • The American College of Cardiology
Some organizations asked that the FDA go further in certain areas. The Academy of Managed Care Pharmacy (AMCP) said it was especially concerned about increasing reports of counterfeit medications. The Biotechnology Industry Organization requested that the FDA adopt a uniform national standard for product pedigrees or track-and-trace technology to deter and combat counterfeiting and intentional adulteration. The National Association of Chain Drug Stores reported that many of its members are already taking action to strengthen the domestic drug distribution supply chain, such as supporting wholesale distributor licensure or requiring their wholesale distributors to purchase prescription drugs directly from manufacturers, to cut down on the possibility of counterfeit drugs being sold to pharmacies.

Overall it is impressive that comments in support of strengthening the safety and integrity of the global supply chain were submitted by a very diverse set of stakeholders. How often do health care providers, consumer advocates, unions, chemical manufacturers, and retailers advocate for a particular issue? We believe it is fair to say that ensuring a safe drug supply has overwhelming support, and affects nearly every American family and home.

To read the FDA’s Draft Strategic Priorities for 2011-2015, click here.

We will be closely monitoring any new developments from the FDA and update you when their finalized plan is released.

— Anna Dunbar-Hester, Program Associate Prescription Access and Quality