There have been many ups and downs since I first contacted FDA in 2005 about Ranbaxy’s widespread problems. After eight years, Ranbaxy has been held accountable for falsifying drug data, dangerous manufacturing practices, and compromised drug safety. I am proud of my work on this case and excited to see so many positive actions resulting from this effort.
Up until now, I have worked behind the scenes, helping regulators understand a complicated web of wrongdoing by a major generic manufacturer. I am grateful that I now can become a more visible advocate for improving the quality of generic drugs.
Why This Case Matters
Throughout these last eight years, I have learned a lot about how the US drug supply works. Estimates vary, but conservatively, approximately 80% of the generic drugs sold in the US have ingredients that come from overseas. As much as 40% of generic drugs dispensed in the US are fully manufactured in facilities that are outside the continental United States.
This leads to a very important question: How do we ensure that when you go to your neighborhood pharmacy to get your prescription filled, the generic substitution made by your pharmacist is as effective and safe as the branded drug prescribed by your physician? This is a question that merits careful consideration given the widespread use of generic medicines in our healthcare system. After all, HHS data establishes approximately a 90% substitution rate where a generic equivalent is available at the pharmacy.
Thankfully, a lot has changed in the eight years since I became aware of this issue. FDA now has offices in China and India, the two countries that account for a majority of the manufacturing facilities that make generic drugs for the US market. There are inspectors stationed in the Mumbai office who conduct inspections of the manufacturing facilities in India without planning for an international trip, applying for visas, and informing the manufacturer weeks in advance to expect them on a certain date.
However, these actions are just the beginning.
Because the global supply chain is so complex, there are opportunities for contamination of our drug supply along the way. Regulations are evolving, but their implementation in countries and cultures that are different than the US pose significant challenges to our healthcare system. Hopefully, this case offers an opportunity for a public dialogue on this topic and will drive diverse perspectives and shape the right policy for us.
While those of us involved in this case have worked hard, I know our work has just begun. Through this blog, I hope to foster a conversation about how we can continue this important work and enlist others in keeping our drug supply safe in the US and other countries.
I welcome your comments and input as we discuss various facets of this issue.