I have strong respect for the FDA and its dedicated staff. My eight-year effort to expose fraudulent activity at Ranbaxy has given me unique insight into how the FDA works and how it stacks up to regulatory agencies in other countries. My assessment is that the agency truly is the “gold standard” by which all national regulators should be measured.
However, in today’s complex regulatory arena, even the best can improve. Based on my experience, I have several suggestions for how the agency can better meet the challenges of regulating drugs produced overseas and sold in the U.S. The ideas below are just the start of what will become recurring themes on this blog.
How FDA Stacks Up
When I learned of Ranbaxy’s systematic pattern of data falsification, Current Good Manufacturing Practice (cGMP) violations, backdating of test results, and other fraudulent activities, I contacted several national health regulatory agencies and other public health entities. The U.S. FDA took what I had to say seriously and investigated my allegations to establish their veracity.
Despite the criticism that the U.S. FDA sometimes receives about it being a slow-moving agency, it was the only global health care regulator I contacted that took action to investigate serious wrongdoing by a very large generic drug manufacturer. The system worked in my case; the FDA along with the U.S. Department of Justice conducted an extensive investigation that verified my allegations and bought the wrongdoing to justice. The FDA deserves a lot of credit for staying true to its mission of protecting public health.
Today’s global supply chain for drugs makes it extremely difficult for any regulator to stay two steps ahead of a drug company bent on breaking the law for profit. This is an implicit message from the Ranbaxy case. In today’s environment – where resources are scarce and more and more demands are continually placed on regulators –enforcement is complicated.
Three Areas for Improvement
As the global leader, there are many areas where FDA regulators can better protect the public’s health. Here are a few examples:
- Create a more robust process to review drugs already on the market. The agency has a very robust and transparent process in the way it approves new drugs. Key opinion leaders and patient advocates all have a voice, along with the agency’s subject matter experts, in the approval process. Unfortunately, no such mechanism exists for review of drugs already on the market unless there is a clear correlation between the drug and potential fatalities. Such correlations are often hard to establish categorically, especially in the case of multi-sourced products such as generic drugs.
- Make it easier to access information about the source of generic drugs. Providers as well as consumers should be able to choose the best generic drugs for their needs. There should be a mechanism for establishing the pedigree (transaction history) for drugs entering and distributed in the U.S., as well as a product identifier that allows for products to be more easily verified and tracked. Furthermore, FDA should make public all bioequivalence data for generic drugs.
- Take a more proactive approach to issues with the manufacturing of generic drugs. The recent withdrawal of Budeprion (generic Wellbutrin) because of variance in bioavailability – and the time it took for the FDA to take corrective action – underscores the need for the FDA to be nimble and anticipatory. Recalls and withdrawals of drugs for manufacturing or other defects is a complicated process, but from the perspective of patient care, a rapid and timely notification process is essential.
Hopefully, the events of the past few months, including the incident at the New England Compounding Center, will create greater demand for transparency and a sense of urgency in dealing with emerging challenges with our health care system.
I look forward to reading your thoughts in the comment section and continually revisiting this topic in the future.