Generic drugs – Outsourcing – Regulations

government, healthcare 0 comments

Generic Drugs – Outsourcing – Regulations
Tariffs – Pharmaceutical Quality

It this good medicine?

Sunday morning, I was flipping through TV channels searching for something substantial. I found it. Generic Drugs.

A cable news show I never heard of – Full Measure, hosted by Sharyl Attkisson (Click to see video or full transcript).

The topic was directly related to healthcare… more specifically to the drugs we take.

Here’s the shocker:

“China is the largest global supplier of medicinal ingredients of generic drugs.”

There’s been a quiet but dramatic shift in where we get our prescription drugs. We are increasingly dependent on China. And that could be a major national security risk. Healthcare author Rosemary Gibson makes a convincing case in the new book: Chinese R-X: Exposing the Risks of America’s Dependence on China for Medicine.

Sharyl Attkisson: Do doctors know about this and take this into account when they’re prescribing?  

Rosemary Gibson: Doctors have no clue, doctors and patients, No one really knows about this big shift in where our medicines are coming from.


Let me first state that I am grateful that China and India are providing our generic prescription drugs at prices that most Americans can afford. However, I am continually dismayed at the lack of transparency and the outrageous costs of medical care in America. 

This is NOT about China and India.

My frustration is due to the lack of control that “we the people” seem to have. 

↠ Please do not misunderstand. I have purchased and continue to purchase, many herbal supplements from other nations, including China and India. However, as an independent consumer, purchasing on my own behalf, I am able to conduct my own research into the manufacturers, and am also able to read reviews at various websites pertaining to the ingredients, the products, and the company. When we purchase our generic drug prescriptions from a pharmacy, we are unable to perform due diligence on our purchase. 

That is a problem. 🤔

 

How often are generic drug manufacturers inspected (domestic and foreign)?
 How often are generic drugs tested to prove they are viable (domestic and foreign)?
 
 

After viewing the show, I began to do a little research and found some interesting information. As one who considers myself up-to-date on most political issues, I was amazed that I was not aware of the fact that most of our prescription generic drugs are sourced from China. Further research shows that they come from India also.

 

How could I not know that our generic ingredients were outsourced abroad? 

 

Was this covered on news networks?
Local news channels?
Dr. Oz?
The Doctors?
PBS?
NPR?

Did our pharmacies notify us?

It seems to me that in this renewed age of “made in America,” that someone should have brought it to our attention, especially considering that half of Americans take at least one prescription medicine daily. Do we not have the right to know where they came from?
Of course, many may argue that the manufacturer is listed on the product (or with the paper accompanying the product), but that detail may easily be overlooked by consumers who continue to assume that our medinal products are under stringent oversight – right here in the US of A.
Compare the label of a prescription drug to the label of a vitamin, mineral, or herbal supplement. The difference is amazing. The latter labels indicate how much of an ingredient is included, how it was extracted, where it was extracted from, whether or not it’s vegan or kosher, and even includes the fillers used to produce the product (when in tablet or capsule form). Some of the more discerning manufacturers also include comforting facts such as the removal of any toxins from the ingredients.
So, as you can see, this problem is not about where the ingredients come from, it’s about being allowed to know the details about the medicine. 
 

The New York Times reported on this disturbing “move abroad” in January, 2009. My youngest graduated from High School that year, and we moved to Arizona that fall, so I guess I was preoccupied with personal life events. My bad.

“The lack of regulation around outsourcing is a blind spot that leaves room for supply disruptions, counterfeit medicines, even bioterrorism,” said Senator Sherrod Brown, Democrat of Ohio, who has held hearings on the issue. Sen. Brown on Twitter.

The critical ingredients for most antibiotics are now made almost exclusively in China and India. The same is true for dozens of other crucial medicines, including the popular allergy medicine prednisone; metformin, for diabetes; and amlodipine, for high blood pressure.

 

 

Of the 1,154 pharmaceutical plants mentioned in generic drug applications to the Food and Drug Administration in 2007, only 13 percent were in the United States. Forty-three percent were in China, and 39 percent were in India.

 Generic Drug Applications to the FDA in 2007

 

  • 13% – US
  • 39% – India
  • 43% – China

Upon learning of this medicinal outsourcing, my  thoughts wandered to the most important issue here – the safety of outsourced ingredients. Are we sure that the ingredients are safe?

I discovered that China has their own FDA – literally – their own Food and Drug Administration, sometimes referred to as the CFDA, but also as the FDA throughout manufacturing facilities in China. When we are reading about ingredients or products that have been FDA approved, how can we know for sure if we are speaking of the CFDA or the US FDA?

Does it matter? Do we trust the CFDA? Even if we do trust tFDA and the CFDA, do we trust the individual manufacturers, here in the US and abroad? That’s certainly some food for thought.

 

Where do we draw the line?
 

 

Who do we trust? 

 

“Part of the reason these plants went overseas is that the F.D.A. inspects domestic plants far more often than foreign ones, making production more expensive in the United States.” NY Times

 

The Federal Government of the U.S. is supposed to protect the people. It appears that they only consider that protection as it pertains to terror and war time threats. They are wrong.

Protecting the citizens of the U.S. should include protecting our health, our food, and our environment. 

China Manufacturing of Most US Medicine and Vitamins Poses Security Threat, Researchers Say. By Annie Wu and Joshua Philipp. April 19, 2018.

 

China has been relying largely on generics. Of about 170,000 drug approvals issued by the China FDA, over 95% are generics, according to the country’s National Health Commission. But many generics in China are poorly made and much less effective than their originals. To eliminate those low-cost, low-quality copycats, CFDA is in the process of a generics bioequivalence evaluation campaign.

Higher prescription drug costs partly due to Trump tariff increase…

China, according to the Food and Drug Administration, is one of the largest suppliers of ingredients used to make U.S.-consumed prescription drugs. 

The Trump administration’s list of Chinese-manufactured products (Bloomberg.com) that could be slapped Ta 25 percent tariff includes many ingredients used to manufacture drugs such as insulin, antidepressants and the anti-allergic-reaction drug epinephrine. 

 

 

 

The Chinese government has suggested a new policy that allows them to self-designate labels that would allow a lower corporate tax rate.
 

The policy also makes clear that China considers compulsory patent licensing a bona fide option during public health emergencies or shortages of key drugs.

 



There you have it. A ton of information regarding the manufacture of generic drugs.

I am currently watching a video presentation from the Generic Drug Forum 2017, “Pharmaceutical Quality Update,” presented by Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality.


Am I an alarmist? I think not. 
Am I a concerned consumer? ABSOLUTELY!