In the past few years, drug companies have been neglecting their factories and operating under illegal conditions. Six of the major drug companies for injectable drugs have been warned by the Food and Drug Administration (FDA) about serious violations of manufacturing rules. Four of these six have actually been forced to close factories and significantly slow production in order to fix the problems. A few of the extreme violations include inspectors finding bugs floating in viles of drugs, morphine containing up to twice the labeled dosage, manufacturing plants with rusty tools and mold in production areas, and in one extreme case- a barrel of urine in the midst of the operating facility.
A lot of these violations have caused drug companies to produce faulty product, which in in turn results in a recall of their drugs; costing the company thousands of dollars in lawsuits and causing the factories to work over time to make up for the lack of product from the recall. So, why are these problems not getting fixed? It sounds like cleaning a factory or shutting it down for a bit in order to fix problems to meet healthy and safety codes can’t be too difficult, right? Well, the drug companies keep brushing their violations under the rug and biting the bullet and paying for the fines because stopping production for them is too costly. The drug companies would rather pay the fine and keep producing rather than shut down for a couple days. In a business where profits are driven by volume, shutting down means huge losses. Many of the basic drugs are already selling for less than a dollar a vile and are made in batches of tens of thousands of viles. Many times, these viles run on lines that operate for 24 hours at a time.
This problem is then made even worse when patents on drugs expire, causing other companies to make the same drug and sell it at a lower price. This cut throat environment between companies competing for the lowest production costs is taking its tole by resulting in recalls of drugs and even outbreaks of sicknesses from various medicines produced in unclean manufacturing plants.
After learning about quality management in our last class, I think drug company standards need to change and laws should be put into place that require these companies to operate under six sigma or ISO 9000 quality standards. Recalls on drugs have the potential to be deadly, and drug companies should’t need to put profit above the importance of adhering to health and safety standards. After learning about quality management, inventory management, and operations strategy, do you have any ideas on a solution to this problem? Do you think that the FDA should enforce their laws in more standardized way? Will this become a never ending problem due to implicit conditions?
http://www.telegram.com/article/20121018/NEWS/110189772/1116
It seems like one of the only ways to solve the problem is for the FDA to get a lot tougher. They may not be overseeing the actions taken after a warning or fine is issued, so it’s possible that the pharma corporations are continuing business as usual. More supervision following a slap on the wrist might be beneficial. Another route would be to increase the fines across the board. These companies are continuing to operate because the paying the fines is more cost effective than shutting down a facility. If the fines are so cost prohibitive that it becomes less expensive to shut down rather than pay the fine, the executives may opt for the latter.
I agree that this is a serious issue and the FDA needs to crack down. This is not only an ethical issue because the company would rather choose making profits over the safety of their products but is lacking operations management. Management should be more strict on this process and make sure that their products are meeting a high quality standard. Millions of people use these products and the FDA needs to be more strict. Even if it is more expensive to clean and stop production, in the long run it will make more sense to meet high quality and not pay fines. Companies should think of the long term results of this because if the FDA get more stricter and they have to recall more products, it would probably be less costly and more ethical to have just have fixed the problem in the first place.
The aspect of this I find most upsetting is the fact that these companies are aware that these violations are taking place and yet they seem uninterested in proactively correcting the issues. I completely agree that the FDA needs to place tighter regulations on these companies. Unfortunately, I ultimately feel that something devastating will need to happen before anything is done. Consider the recent oil spill in the Gulf – there are many reports that BP was fully aware that there were issues with their rig, and yet they didn’t address any of them until it was too late. Hopefully these companies take action before they encounter a similar experience.
I believe the large pharmaceutical companies enjoy a great deal of freedom and relatively little oversight into their business practices from outside sources. I also think that the FDA is not enforcing any serious sanctions or reasonable regulations on the pharmaceutical industry at this point in time.
I think that quality control measures should be put in place by an organization that constantly proves it does not share business interests with the major companies in the pharmaceutical industry to resolve this problem. However, it appears that control of the industry is closely guarded by those protecting the business interests of the large corporations today, so implementing serious quality control measures will be challenging.
It would take a large scale effort and the support of a great deal of organizations and people to achieve any measurable improvement on the quality and choice of medicines offered by the pharmaceutical industry to the world.
While I do agree that generic drug manufacturers may be to blame for many quality control issues, I think that those companies are put in an unfair position because they cannot legally produce the most valuable drugs due to patent restrictions. This forces them to find alternative ways to create profits.
The country of India has spoken out against the unfair practices of the major pharmaceutical corporations by producing generic versions of cancer fighting drugs while they are still patent protected. Patent laws will need to be changed before any serious progress can be made in this respect.
The business interests of drug manufacturers suggest that they will invest in creating drugs for consumers who can pay the most. These consumers are looking for drugs to resolve problems that are minor in comparison to the greatest overall medicinal needs of the global human population.
Because of this, drugs to prevent the most prevalent and deadly problems will not be produced and instead, research, development and manufacturing resources are invested in resolving less common problems that affect a small percentage of the population.
To me, this suggests that the operational strategies of the drug manufacturers need to be changed, so that human research and innovation can be focused in a direction that can produce more significant benefits and improve quality of life for more people.
This is a great article in that it questions the same aspect of quality management that I wrote about last week. My huge position on this issue is: Ethics. I think that if there were rules and regulation like ISO 9000 but also ethical employees then this wouldn’t happen. Hopefully someone higher up than the FDA steps in because the FDA serving warning actually doesn’t serve anyone any good. What is important is that these corporations and their staff realize the impact that their job has on the population of the country. For example, I recently learned the importance of due diligence by packing a parachute for a skydiver. I knew I had to do everything correctly because if I did something wrong that skydiver’s life was at risk. These pharmaceutical corporations need to provide that type of training- then again most corps don’t learn their lessons until something goes terribly wrong with money just how accounting regulations weren’t changed until the huge scandal with Enron.