So You Like Thoose Cheap Drugs ?

GURPS

INGSOC
PREMO Member
If Globalization Meant China Could Turn off Your Fridge, Would You Still Like It?

The pill many people take in the morning may have come a long way to the breakfast table, from the other side of the world, in fact. "America needs generic drugs. They make up 90 percent of the American drug supply. Without them, every large-scale government health program — the Affordable Care Act, Medicare Part D, the Veterans Health Administration, charitable programs for the developing world — would be unaffordable." In the fall of 2012, an FDA employee tasked with "inspecting the Indian manufacturing plants that make many of America’s low-cost generic drugs" discovered that its reputation as "the world leader in aseptic manufacturing" was a fraud.

On his second day at the Wockhardt plant, Mr. Baker and a colleague caught an employee trying to smuggle out a garbage bag of documents. The documents led Mr. Baker to discover that the plant had knowingly released into Indian and other foreign markets vials of insulin containing metallic fragments. These had apparently come from a defective sterilizing machine. He learned that the company had been using the same defective equipment to make a sterile injectable cardiac drug for the American market. The willful deception there and at other plants so shocked him that he overhauled his inspection methods, with significant results. ...
Mr. Baker kept digging. Over the next five years, first in India and then in China, he uncovered fraud or deceptive practices in almost four-fifths of the drug plants he inspected. Some of the plants used hidden laboratories, secretly repeated tests and altered results to produce fake data that fundamentally misrepresented drug quality, then submitted that data to regulators.


https://pjmedia.com/richardfernandez/if-the-globalization-meant-china-could-turn-off-your-fridge-would-you-still-like-it/
 

Hijinx

Well-Known Member
As I understand it .Generic drugs are basically the same as those provided by the true manufacturer.
I know that when I go to the pharmacy and buy drugs with the CVS label on them and read the ingredients they are the same as the name brand.

My question is why are there generic drugs. If the generic people can make the same drug cheaper, why can't the name brand folks compete?
I know about research and development, and it's cost, but once the drug goes generic, that goes out the window and the name brands should be competitive. That's my opinion anyway.
 

Chris0nllyn

Well-Known Member
My question is why are there generic drugs. If the generic people can make the same drug cheaper, why can't the name brand folks compete?
I know about research and development, and it's cost, but once the drug goes generic, that goes out the window and the name brands should be competitive. That's my opinion anyway.
Because name brand drugs hold patents and/or exclusivity rights for upwards of 20 years. Name brands don't need to be competitive once generics hit the market.
 

BernieP

Resident PIA
As I understand it .Generic drugs are basically the same as those provided by the true manufacturer.
I know that when I go to the pharmacy and buy drugs with the CVS label on them and read the ingredients they are the same as the name brand.

My question is why are there generic drugs. If the generic people can make the same drug cheaper, why can't the name brand folks compete?
I know about research and development, and it's cost, but once the drug goes generic, that goes out the window and the name brands should be competitive. That's my opinion anyway.
I think only the manufacturer can answer that question. The rationale they give for the higher price (to start with) is in part true, they have to pay back the R&D invested in that drug plus cover the R&D costs from the 100 other drugs that didn't pan out. That's why they have the patent on the drug, to protect them while they recover their costs. Once the patent is up, I can't tell you if they drop the price or maintain the price at it's previous level. If memory serves, I think I've seen the price of certain items come down and be competitive with the generic. This allows physicians to write a prescription for the name brand. Some doctors prefer the name brand because they feel the quality is better. The don't have imperical d


I also don't know what the investment is for the generic pharmaceutical manufacturer to get a generic approved. Do they still need to do the clinical trials, or do they just get approved by demonstrating the drug is the chemical equivalent of the name brand?
 

Clem72

Well-Known Member
I also don't know what the investment is for the generic pharmaceutical manufacturer to get a generic approved. Do they still need to do the clinical trials, or do they just get approved by demonstrating the drug is the chemical equivalent of the name brand?
The approval only requires that they meet the standard for bioequivalence, which is pretty broad. I believe they need to be within +/- 25% of the active ingredient concentration, and there is no requirement for equivalent excipients. Additionally, they are typically reverse engineered and so not produced in the same way either or from the same sources. So most generics are pretty good, but some are significantly different than the name brand.
 

Chris0nllyn

Well-Known Member
The approval only requires that they meet the standard for bioequivalence
Bioequivalence is one method of showing the generic drug performs the same way at name brand. It has to be the same amount of active ingredients as the name brand and it has to reach the blood stream in the same amount of time.

Approval requires more than that.

The active ingredient must be the same, the same strength, same form, same type of administration. Inactive ingredients must be acceptable. Manufacturing process has to be as strict as name-brand, and the container/label meets applicable standards.

The FDA spells out all that's required to filed an ANDA form.
 

Clem72

Well-Known Member
Bioequivalence is one method of showing the generic drug performs the same way at name brand. It has to be the same amount of active ingredients as the name brand and it has to reach the blood stream in the same amount of time.

Approval requires more than that.

The active ingredient must be the same, the same strength, same form, same type of administration. Inactive ingredients must be acceptable. Manufacturing process has to be as strict as name-brand, and the container/label meets applicable standards.

The FDA spells out all that's required to filed an ANDA form.
Yeah, hey I can read the FDA Frequently Asked questions on Generic Drugs as well. Which part of my post did you take issue with, the +/- 25% of the ingredient because that doesn't match the FAQ answer of "same strength"?

Because I can actually point to that in CFR (which is linked in that same FAQ you paraphrased)
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2018]
[CITE: 21CFR320.21]
PART 320 -- BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Subpart B--Procedures for Determining the Bioavailability or Bioequivalence of Drug Products

Sec. 320.21 Requirements for submission of bioavailability and bioequivalence data.

(2) There are data measuring significant intra-batch and batch-to-batch variability, e.g., plus or minus 25 percent, in the bioavailability of the drug product.
I will save you the hassle of parsing the entire regulation. If your result(s) are within 25% of the value given for the original formulation it will be considered equivalent. Which is what I said.
 

PeoplesElbow

Well-Known Member
One of my closest friends that I met while in college is a principal scientist for a pharmaceutical company, he has a PhD in biochemistry and has worked in quality control for drug companies since the mid 90s.

The amount of equipment and testing done to american sourced drugs (even generic) is unreal. Generics usually only make money due to sheer quantity and sometimes then are only made for the purpose of lowering the sharing the overhead costs with the stuff that makes money or keeping the lights on until a drug company gets something that makes money.

I would not in any way shape or form even take an aspirin that was made in China or India.
 

PeoplesElbow

Well-Known Member
I think only the manufacturer can answer that question. The rationale they give for the higher price (to start with) is in part true, they have to pay back the R&D invested in that drug plus cover the R&D costs from the 100 other drugs that didn't pan out. That's why they have the patent on the drug, to protect them while they recover their costs. Once the patent is up, I can't tell you if they drop the price or maintain the price at it's previous level. If memory serves, I think I've seen the price of certain items come down and be competitive with the generic. This allows physicians to write a prescription for the name brand. Some doctors prefer the name brand because they feel the quality is better. The don't have imperical d


I also don't know what the investment is for the generic pharmaceutical manufacturer to get a generic approved. Do they still need to do the clinical trials, or do they just get approved by demonstrating the drug is the chemical equivalent of the name brand?
Here is a very good article about the process, notice it is from 2002.

https://www.forbes.com/2002/05/02/0502patents.html#21e2dd5117bc

Notice that the 20 years starts as soon as the patent is filed, and it can take years to get approval, hence the get as much the money while you can mentality.
 

Hijinx

Well-Known Member
I went and looked at all of my prescription medicines and could not find a one that had the place where they were made stamped anywhere on them.
 

Merlin99

Visualize whirled peas
PREMO Member
I went and looked at all of my prescription medicines and could not find a one that had the place where they were made stamped anywhere on them.
It doesn't state a country of manufacture, but it does state who the manufacturer is. Looking at a bottle of Zolpidem, the generic for Ambien, the manufacturer is Torrent pharmaceuticals. A quick internet look shows Torrent is out of Gujarat, India.
 

Hijinx

Well-Known Member
It doesn't state a country of manufacture, but it does state who the manufacturer is. Looking at a bottle of Zolpidem, the generic for Ambien, the manufacturer is Torrent pharmaceuticals. A quick internet look shows Torrent is out of Gujarat, India.
If other merchandise has to say where it is manufactured why isn't this a requirement for drugs. I should have to look for the origin of the country , it should be stamped right on the prescription Made in India.
 

officeguy

Well-Known Member
Can't win. If we insisted on domestically produced brand name drugs, folks would rag on the 'monopolistic pharmaceutical racket' and the hight cost. Now that the we import 80% of the generics from india and china, folks are complaining that there are quality control issues. Can't have it all.
 
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