CAPAITAL REGION, N.Y. (NEWS10) – Some local cancer patients are in danger of delaying treatment because of a shortage of chemotherapy drugs. NEWS10 shows you what could be behind the shortage, and what patients can do to make sure they don’t skip any treatments.
Susan Dyson, who is battling a reoccurring cervical cancer and has received the same chemo treatment for months, learned yesterday that she needs to look elsewhere.
“I was kinda in shock. I just kept asking how it could be possible that this happened, and you know I just couldn’t believe it,” said Dyson.
The FDA recently added four cancer drugs to their list of drugs in short supply, including Dyson’s.
“It worked the last time. Unfortunately, this is the type of cancer that just keeps coming back so I’d like to stay with the same regiment,” said Dyson.
New York Assemblymember and local pharmacist John McDonald says the government is cracking down on drug manufacturers not following regulations.
“The FDA is now much more aggressive in monitoring these facilities and to the point where they shut them down. And when they shut them down, that may be the only supplier. It might take up to a couple of months, but it’ll take a couple months for all the existing supply out in the chain, in the supply chain to eventually exhaust itself,” said McDonald.
Dyson receives her care with Berkshire Health Systems, we reached out to them, and no one was able to go on camera, but they sent us the following statement:
“The United States Food and Drug Administration (FDA) currently reports a nationwide shortage of cisplatin and carboplatin, chemotherapy drugs used to treat gynecologic, breast and lung cancers. This shortage is impacting cancer centers across the country, including Berkshire Health Systems’ Phelps Cancer Center. Berkshire Health Systems is working closely with all of our cancer patients to ensure proper therapy based on each individual’s care needs, following guidance from Society of Gynecologic Oncology (SGO) and the National Cancer Comprehensive Network.”
McDonald says there are few things patients can do if they find their drug supply has run dry.
“There are options and providers usually choose the option based on could be more effective, also which one has less side effects. In other words, what’s going to enhance patient performance and compliance and that’s how we look for positive outcomes,” said McDonald.
The FDA website does confirm the shortage, yet it fails to thoroughly identify the reason. We contacted the FDA, and they sent the following statement.
“The FDA recognizes the potential impact that increased demand of certain products may have on health care providers and patients. While the agency does not manufacturer drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug, the public should rest assured the FDA is working closely with numerous manufacturers and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or increased demand of certain products. The FDA understands that manufacturers expect availability to continue to increase in the near future.
Regarding cisplatin, the FDA added cisplatin to its Drug Shortage Website on February 10. The FDA is in frequent communication with all manufacturers of cisplatin, and one of those companies, Accord informed the FDA that they have halted distribution temporarily. Other manufacturers continue to produce cisplatin, but currently without Accord’s distribution, there is not sufficient supply to continue to meet U.S. market demand through just those companies. We understand from Accord they have begun to release cisplatin again and we will continue to work with Accord and the other companies to resolve this shortage.
Regarding Pluvicto, the FDA added Pluvicto to its Drug Shortages website on March 7. As noted in the website’s entry for Pluvicto, there are challenges in meeting demand and no therapeutic equivalents are available. FDA continues to work with the company to increase supply to meet all patient needs.
Regarding carboplatin, the FDA added carboplatin to its Drug Shortages website on April 28. As noted in the website’s entry for carboplatin, there are five manufacturers of the product who list either demand increase or “other” as their reason for shortage. FDA is working with all of the manufacturers of carboplatin to resolve this shortage.
Regarding BCG, there is only one U.S. Licensed source of BCG Live (Intravesical). TICE® BCG [BCG Live (Intravesical)] – manufactured by Organon Teknika, Corporation LLC, a subsidiary of Merck & Co, Inc.
Since Merck became the only source of BCG Live in the United States in 2012, they have been in ongoing communications with the FDA regarding current and future supply situations. Merck has informed FDA, that there has been an increase in demand globally and as the only source of BCG Live (Intravesical) in the United States and many other countries, they anticipate ongoing supply constraints for TICE® BCG for the foreseeable future. TICE® BCG is currently available. However, in order to and address the imbalance between supply and increased global demand, help manage inventory, and to minimize a complete disruption to patient care, the product has been placed on allocation. This means Merck is proportionally allocating the quantity of available TICE® BCG supply across countries based on historical demand. Merck announced it will construct a new manufacturing facility to significantly expand its production capacity for TICE® BCG Live (Intravesical). Once this new facility is fully operational, it is our understanding that Merck will triple its current manufacturing capacity, which is expected to support the anticipated demand for TICE BCG for the foreseeable future.
FDA continues to work very closely with Merck to help mitigate the supply situation for TICE® BCG. As part of our efforts, FDA has proactively engaged stakeholders including cooperative groups, pharmaceutical sponsors, health care professional organizations and patient advocacy organizations to encourage further study and development of alternative sources of BCG. In addition, FDA periodically reaches out to foreign regulatory counterparts to assess the global marketplace. Additional information about this shortage can be found on FDA’s website here.
You can find out more about how the FDA responds to potential availability concerns and the various actions the agency is able to take to help increase product availability on our website. The FDA will also continue to update our CDER Drug Shortage website if new information becomes available regarding supply.
To note, the FDA tracks product availability at the national level and receives information from manufacturers about their ability to supply the market. The FDA lists certain products on our website when the total supply of all versions of a commercially available product cannot meet the current demand, and a registered alternative manufacturer will not meet the current and/or projected demands for the potentially medically necessary use(s) at the patient level. Please see our FAQ website, which provides additional information regarding the differences between our availability determinations and ASHP’s website, specifically why something may appear on their list but not the FDA’s, despite local increased demand that may be observed. Please check our website for any updates regarding availability of certain drugs, including information on the reason for specific availability issues and when they are expected to resolve.
Importantly, regarding potential supply disruptions due to increased demand — while companies are required to notify the FDA of supply disruptions (such as an issue obtaining raw materials), there is not currently a law that requires companies to notify the agency of increased demand. The FDA continues to encourage companies to notify the agency when there is a spike in demand so that they can work with them early on to mitigate or prevent any impacts on availability.”
Dyson says Berkshire Health is helping to find her another facility that is in supply of her drug so that she can continue with her treatment.