Drug Dealers Beware!

 

How can improved quality control and diminishing quality control both work to save lives?

 

In the world of quality assurance, it is a rare thing to talk about quality within the public sector.  The public assumes that quality exists but nothing is ever thought of in regards to the measures are needed to make sure things are done correctly.  While reading this you will find two sides of the FDA.  One side of the FDA ensures the safety of people through increased quality control measures.  The other side of the FDA is hoping to remove some quality control measures in hopes of saving lives.

 

The FDA has begun rigorous efforts to take counterfeit and harmful drugs off of the internet.  http://www.reuters.com/article/2012/10/04/us-fda-baddrugs-idUSBRE8930SN20121004

 

In a time of rising health care costs and pricey prescriptions, consumers have looked to various other sources to save money.  A great source to purchase prescription medication is online.  However, many of these online retailers are distributing “counterfeit and illegal” medicine.   The FDA has joined forces with international regulatory and law enforcement agencies in an effort to take some of these dangerous drugs off the market.    18,000 online pharmacies have been shut down in the matter of just one week starting September 25th.    This is essentially a form of quality checking within the public sector.  The FDA is hoping to make sure that the medicines available to the public have gone through the testing process.  All of these regulatory agencies are working towards a pharmaceutical industry with high standards of quality.

 

In contrast, the FDA is also working to remove some of the quality processes associated with the drug approval process.  This comes mainly from a Republican push hoping to remove regulations across the board.  These deregulations are not meant to send harmful drugs out on the market prematurely.  This measure is hoping to assist immediately ill individuals that cannot wait through the testing process.  The FDA has been doing this since the 1990’s.  Currently patients within this characterization include aids and cancer patients.  However, the FDA is hoping to include various other threatening diseases/conditions to this “accelerated approval” process.  “Of 35 medicines termed innovative by the FDA and approved during fiscal 2011, 16 have some sort of shortened review or expedited approval” (Burton 2012).  The key is that people with “life threatening” conditions are more willing to try riskier drugs.  These people do not have the luxury of time to wait through the quality assurance process.

 

The point of this shows how quality assurance is paramount in some regards and in other circumstances it serves as handcuffs for progress.  The latter tends to be rare but it does point out that too many regulations have harmful effects.  We can clearly relate this to the upcoming elections as republicans and democrats battle over the topic of increased regulations.  There are clear positives for both sides.  Too many regulations impede progress and at times create a feeling of too much governmental control.  Not enough regulations also have catastrophic results.  Going back to the initial topic, if the FDA did not thoroughly check items that came through their department, people’s lives would be in danger.   People would not be aware of the harmful side effects of the things they are ingesting.  The perfect middle ground is a difficult thing to find and seems to be an ongoing battle within our society.

 

Sources:

http://online.wsj.com/article/SB10000872396390444083304578018790623838634.html

http://www.reuters.com/article/2012/10/04/us-fda-baddrugs-idUSBRE8930SN20121004

6 thoughts on “Drug Dealers Beware!

  1. I feel this is a good post and very relevant in todays society and in managing quality. What comes to mind first is crosby’s 4 absolutes of QM which are: conformance to requirements, prevention, zero defects, and the price of non-conformance to determine absolutle quality. This seems impossible in the multi billion dollar world of precription drugs however. Both sides have their own agendas and the public seems to suffer from this half hearted attempt at quality assurance.

  2. This is a very interesting and relevant post. I actually met someone who is an innovator a process to make it simple and the idea will be huge. Most hospitals will be interested in the product. There are many regulations that new products, innovations, and drugs have to meet. As far as the innovations and products go, they must be tested with its use, and with many different chemicals in order to see what will happen in many various situations. I am glad that the process to get FDA approval will not be as inefficient as the process currently is.

  3. This post is very interesting and is a great example of quality control. I agree that drugs need to be tested in various situations and glad the FDA is out there to protect citizens. Bringing up the exception that people who have Aids or cancer is important in attempt to save their life. Crosby’s 4 absolutes of quality management is impossible in this situation because all drugs have long term effect on people. Drugs help people, but also can be very harmful for the body so zero defects are impossible in this industry.

  4. It is crazy to believe how many counterfeit drugs are out there, especially in the internet. I’m glad the FDA has stepped up to the plate and make sure all drugs have gone through testing/ inspection. This is a wonderful example of quality control, as everyone has so far mentioned and it is definitely interesting to see it take place within the federal level.

  5. I appreciate the FDA looking into testing, inspection, and clinical studies. I work at GNC and daily I see another email from the FDA asking for evidence that the ingredients in our products, are actually the ingredients in our products. They usually accomplish that with ‘aceing’ (Aceing means to show up unexpectedly at the labs) the scientific labs. I respect that the FDA is taking initiative to clean up the pharmeceutical/supplemental/and drug world.

  6. I believe that the FDA is doing a superb job of protecting the public by going after these online pharmacies. In our time it is becoming easier to make a profit at the expense of the health of the unsuspecting. These online pharmacies should be investigated and vetted properly before being allowed to operate. There should be greater barriers to entry into the pharmaceutical market, and the FDA is that. The FDA, in my opinion, should thoroughly check the quality and the safety of all drugs. I understand that in some cases the FDA may take too long, but I feel that lowering these standards may lead to diminished quality over all. Therefore, I would not support deregulations across the board. Interesting and insightful post.

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