We are at the halfway point in this series! Yet to come is today’s synopsis from the Food and Drug Administration (FDA) and in the final 2 entries, an opportunity to understand the thoughts of Pfizer (who manufactures both brand name and generic medications) and finally an overview of proposed solutions and tips on what you as a person touched by cancer can do.
Today’s blog will outline the work of Dr. Sandra Kweder, MD, Deputy Director in the Office of New Drugs and Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). Dr. Kweder is a Rear Admiral in the Commissioned Corps of the U.S. Public Health Service (PHS) where she has been recognized by the receipt of several awards including the PHS Outstanding Service Medal and two PHS Meritorious Service Medals. Her career accomplishments and public service are extraordinary and can be found in full here.
Dr. Kweder’s overview provided a look into the experience and response of the FDA—- starting with a reminder of the drug supply sequencing. This sequence begins with the suppliers who provide the materials used to make medications then to the manufacturers who make the medications and then to the wholesaler who sells it to the healthcare professional who then delivers it to the patient. It is important to note that each of these steps is regulated with a primary interest in safety. And, each is a point where a break can occur (think links in a chain).
She covered some of the same points noted in the earlier presentations including the rising number of shortages and the challenges with manufacturers. However, she gave some very specific numbers that I found interesting. According to Dr. Kweder, 75% (3 out of 4) sterile injectable drug (like chemotherapy, antibiotics— or anything that would be given through a needle) shortages are a result of product quality concerns & production delays. Some of the examples she noted were bacterial or mold contamination, particles (glass, etc.) in the medication vials, equipment breakdown and natural disasters to name a few.
In 1999, the FDA opened an office to specifically focus on the drug shortage. She noted that there are 11 full time staff working on the issue and they have been able to institute some solutions in an attempt to mitigate the problem including ‘early warning’ notifications from manufacturers, partnerships with companies to address some issues (using filter needles to eliminate particles, warming procedures to dissolve crystals, expediting the review of new applications, etc.). She further notes that on 9 occasions, the FDA has allowed importation (temporary) of drug from ‘unapproved’ sources. She cautions that this does create a bit of pause because medications manufactured for uses outside the U.S. are different (concentration, dose, etc.) so the risk for error increases. As a result of their work, in 2010 alone 38 shortages were prevented.
One of the issues Dr. Kweder did not speak to but was mentioned by Dr. Chabner, and I will briefly mention, is FDA resources, and particularly humans. There simply are not enough people to do all of the work that needs to be done including facility inspections as well as application processing – and remember that the FDA is responsible for our food safety, too! Please hold on to this bit of information when we get to actions you can take in a later blog.
As you can see, this issue is complex. Dr. Kweder was adamant that the FDA would not risk patient safety standards and we all agreed. Given the options to raise behaviors to ensure a safe drug supply or decrease safety expectations to ensure adequate supply, without hesitation, our patients deserve to receive drugs they know are safe and effective.