Many drugs (mostly brand name) are manufactured by a single company, making the community entirely dependent on that company. The federal government already requires such companies to provide notice if they anticipated a production problem that could result in a shortage. However, 80 percent of drug shortages in this country are of sterile injectable drugs (including methotrexate) which have necessarily high sterility standards for production and therefore production problems are more difficult to address. Many of these drugs are generic, made by multiple manufacturers and not covered by current federal shortage notice requirements.
“This is an area of particular concern because it takes longer to get a new facility approved by the FDA. Many of these drugs are made by multiple manufacturers, but because of the complexity and sterility standards, it is not easy for one manufacturer to ramp up for increased production to compensate for a production lag at another facility or manufacturer,” said B’nai B’rith International President Allan J. Jacobs. “But we believe solutions are available and this potential crisis can be averted if Congress continues to pursue reasonable solutions by working with consumer groups as well as the pharmaceutical and generic pharmaceutical industry.”
The Generic Pharmaceutical Association has proposed a solution which would involve a requirement of generic manufacturers to report potential problems to a third party which would be able to track the manufacturing process. As it stands, manufacturers are unaware of one another’s production schedules and would not know to ramp up production if there was a shortage.
“Telling a third party instead might allay a company’s concerns about sharing too much information with competitors while still giving those competitors the lead time they need to get more facilities online to prevent shortages,” said B’nai B’rith International Executive Vice President Daniel S. Mariaschin.
Sen. Amy Klobuchar (D-Minn.) has also proposed legislation that would require manufacturers to notify FDA of potential shortages even when they are not the only company making a drug, as is the case with generic drugs which usually have multiple manufacturers. While this is a promising idea, there are potential pitfalls. Manufacturer problems are sometimes sudden and making potential production problems public record could result in market manipulation or stockpiling which could lead to regional shortages.
As a steadfast advocate for access to quality and affordable health care as well as seniors issues, B’nai B’rith International will continue to monitor this subject to ensure any potential drug shortages have limited consequences for those relying on specific medications.