The U.S. Food and Drug Administration is working to reverse a shortage of critical oncology drugs that has hindered veterinarians and physicians in providing appropriate patient care and forced them to make difficult treatment decisions.
In mid-September, the FDA placed 27 oncology medicines on a shortage list, including cisplatin and carboplatin.
“To restore cisplatin, FDA has continued to offer assistance to all five manufacturers on anything they can do to increase supply,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and the acting director of the Office of Oncologic Diseases. “In addition, we are exploring temporary importation to help meet patients’ needs during the shortage.
“FDA has also requested that manufacturers submit data to support additional expiration dating for lots already in distribution that are approaching labeled expiration.”
The shortage forces veterinary oncologists to decide which patients can tolerate medication substitutions or less frequent treatments. They also must consider that drug prices have jumped because of increased demand.
“It’s something that kind of eats away at you a little bit,” said Dr. Terry Hamilton, a recently retired veterinary oncologist, who said the stress from cancer drug shortages was one reason for his early departure. “That you know you’re not doing what you could because of conditions outside of your control. It’s burning veterinarians out. I can only imagine the same thing is happening in human medicine.”
Factors contributing to the veterinary drug shortages include:
- Human health prioritization: Chemotherapy drugs used in veterinary medicine are often given to people. Pharmaceutical companies tend to prioritize human health, limiting veterinary availability.
- Supply chain disruptions: Vial and stopper shortages, transportation problems and other supply chain issues can interrupt medication manufacturing and distribution.
- Regulatory issues: Production is halted when pharmaceutical companies don’t adhere to regulatory mandates.
- A lack of incentive: Pharmaceutical companies don’t have strong financial incentives to invest in veterinary-specific cancer drug research and development.
The cisplatin shortage followed an inspection and identification of quality issues at one manufacturer. The company shut down its production line, which led to the current deficit, Pazdur said. The move heightened the demand for carboplatin.
“Probably the only thing that’s going to change this, unfortunately, is the government,” Dr. Hamilton said. “So, put pressure on your congressmen to really work with pharmaceutical companies to have more redundancies instead of relying on one or two manufacturing plants.”