Regulatory Affairs is a industry that ensures the safety of the public when overseeing food, medical products, and drugs. This management make sure companies making medical devices comply with FDA regulations.What could be an example of a corporation making a medical device NOT complying with FDA regulations. Also, how can that issue negatively affect human wellbeing?
Johnson & Johnson is a giant corporation has been sued multiple times over the years for their products and had paid settlements. More recently, the supreme court in California order Johnson & Johnson to payout $344 million settlement to customers that suffered from using transvaginal mesh products. The multibillion-dollar corporation used their power to maneuver through FDA regulations.
In the US, I think the majority of substantial medical products to be used has to receive FDA approval. But I think the better question to be asked is how can these corporations push out a product that may still have reasonable harm to their consumers and can still receive approval for circumventing or undercut their compliancy indirectly. Examples of corporations making medical products that may not be 100% compliant with FDA regulations can be found everywhere. We have obvious examples like Johnson & Johnson that has a record of being litigated for inadequate and harmful products such as asbestos in baby powder.
A lesser known example of this would be Merck & Co.'s Singulair, a popular asthma medication that has received FDA approval, has a noted usage link to suicide and psychiatric problems. This is obviously a huge issue because although it received FDA approval for its intended use to treat asthma, it created problems that the consumer may not have exhibited prior. Merck has been sued multiple times for this, but ultimately prevailed each time because their product fulfilled the core requirements of what was asked of them in the limited scope of FDA process.
A more positive example would be the medication of Finasteride, which has FDA approval to treat an enlarged prostate in men, but has the unintended effect of stopping or even reversing male pattern baldness. Obviously the latter effect was not its original intention, thus it did not receive FDA approval for its specific use case, but this goes to show that oftentimes the FDA regulations as it stands does not encompass the impacts a medical device or drug can have in regards to and outside its intended use.
Regulatory Affairs is an extremely important industry when it comes to developing new medical devices. FDA approval is necessary to ensure that products on the market are safe for people to use. If a product was introduced to the market that doesn’t comply with FDA regulations, it could have adverse effects like not performing its function or, in the worst cases, harming patients. Legally, this would be extremely problematic as patients would likely file lawsuits if their medical device doesn’t work or causes health complications. If the non-compliant device is discovered to have this issues, it would have to be withdrawn from the market for the safety of the consumers. If this happened very often, consumers would no longer trust medical devices and the industry would suffer. Regulatory Affairs and the FDA are necessary to ensure that never happens.
While the question asks for an example of a corporation not complying with FDA regulations, I feel it’s important to highlight a broader issue—how the FDA has historically been reactive in its regulatory role, often evolving in response to public health crises. The FDA’s creation, rise in power, and regulations as a response to unsafe products harming patients. One notable example is the impact of Upton Sinclair’s The Jungle, which exposed unsanitary conditions in the meatpacking industry, leading to significant reforms and expanding the FDA's powers. I learned about several of these pivotal moments during an outside class I took on FDA history, which provided valuable context on how regulations have developed over time. I was moderately shocked that these moments can be broken down into a table of “Adverse Effects in Patients” and “FDA’s Corrective Actions”.
Even today, with advances in technology, the FDA is still adapting its regulations to address emerging risks. A well-known case that highlights the dangers of regulatory failures is the Therac-25 incident in the 1980s ( https://dspace.mit.edu/handle/1721.1/115298). This radiation therapy machine malfunctioned due to software errors, delivering massive overdoses of radiation to patients. The lack of stringent oversight, failure to update safety protocols, and poor communication between the company’s engineers and regulatory teams led to serious injuries and deaths. This tragedy underscores how crucial it is for companies to stay vigilant in not only complying with updated FDA regulations, but also having a quality right-first-time mindset.
On the company side, the regulatory affairs team plays a critical role in ensuring that devices comply with changing regulations and failure to do so can have severe consequences for patient safety. For example, if regulatory changes are not effectively communicated across departments, errors in device design or manufacturing may not be caught in time, leading to faulty products reaching the market. This can put patients at risk of injury, illness, or even death.
In my opinion, it is really important for a company itself to show that they have the correct quality mindset through audits and without it, they are bound to fail at complying with regulations. Companies must have strong communication and an adaptive regulatory team to stay on top of changes, minimizing the risk of harmful outcomes like those seen with the Therac-25.
