A recent study from Memorial Sloan Kettering Cancer Center found that US drug companies often distribute intravenous cancer drugs in vials that contain more medicine than many patients need.
STATEMENT FROM BIOTECH COMPANY GENENTECH:
It is important to remember that an individual person’s weight and the type of cancer for which they are being treated determine the appropriate dose. In particular, weight can vary among individuals and significantly between women and men, which is why we provide multiple vial sizes so that the health care provider can select the vial or combination of vials that most closely meets the individual patient’s requirements.
All of our medicines are packaged to meet FDA regulations. The FDA calls on companies to balance vial contents so that leftover drug is minimized yet also provide enough drug so that more than one vial is rarely needed for a single dose.
STATEMENT FROM PHARMACEUTICAL INDUSTRY TRADE GROUP PHRMA:
Biopharmaceutical companies are committed to developing medicines that help patients live longer, healthier lives and, in recent decades, there have been tremendous advances in treatment options for patients including those with cancer, arthritis and hepatitis C.
Every medicine approved by the U.S. Food and Drug Administration (FDA) offers a unique value to patients and ensuring access to the medicines they need to help them live longer, healthier lives should be a priority. Determining the right dose for patients happens in the earliest stages of the drug research and development process and is key to establishing the safety and effectiveness of new medicines prior to FDA approval.
The drug development and manufacturing process for biologics, including oncology medicines, is extremely complex. Decisions regarding vial size are tied to a product’s initially approved dosage and labeled use, taking into account that different patients will have different needs. Vial fill size must be approved by FDA as part of the sponsor’s drug application and any excess volume must meet FDA standards outlined in regulations. After initial drug approval, a manufacturer must receive FDA approval to manufacture a new vial size, which requires significant data and will take several months to obtain approval.
Our understanding of optimal use and dosing among diverse patient populations (e.g., sex, age, weight, metabolizing factors) continues even after FDA approval through the use of real-world evidence. Manufacturers are committed to working with FDA and Congress to create a more nimble regulatory approval process that enables manufacturers to modify their products as we learn about the safety, efficacy and manufacturing of new medicines from the real world clinical setting. We must ensure continued access to high quality, patient-centered care while continuing to encourage development of innovative, life-changing medicines.
