This is not a common subject people think about it? However, the medicinces and drugs we consume and buy from CVS are products that are regulated and approved by the government.
Many people consider regulation and government over reach as a "bad thing". This article is not for you, in regards to the history of drug manufacturing and development and cures to diseases you have. Regulation is a key government body to health and safety of patients.
The FDA is a body of government and regulation that ensures the american public we consume safety and effective drugs.
Simply put drugs in the U.S. are required to do two things:
1) They work as intended and designed.
2) They are safe to consume within reasons and labels.
People tend to forget we are at whims of nature the dieases that exist outside of ourselves. We do not have cures for many dieases, so its easy for people to manufacturing solutions and malutiplate people with a fake "cure".
This is historically known as a snake oil salesmen.
How do companies get drugs to market?
Companies are required to sumbit a application like a "job applications". This is extremelly over simplifying the application process. The actually applications occurs for different types of products. You have
- Biological & Therapeutic (Gene Therapy and Proteins)
- Chemicals (Pills, injectables, and patches)
- Chemicals that become generics i.e. patent expired so everyone can make it
- Over the counter
Types of applications
Investigational New Drug (IND)
Current Federal law requires any new drug to be sumbit to the FDA in the form of IND.
That means drug makers have to get approval to make the drug and ship it out to clinical testing sites.
So to even test the drug on people the drug needs to be tested for safety and effectiveness.
This is the application at the start of the 3 phases clinical trials
New Drug Application (NDA)
After the clinical trials, the drug can be sumbbited for New Drug Application (NDA). The NDA is the start of the allowing the company to sell the drug in the market with their patent.
Application must contain data from specific technical viewpoints for review: – – Chemistry
- Pharmacology
- Medical
- Biopharmaceutics
- Statistics
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.
In simple terms, the drug is proven to work, but when you formulate a existing drug that works with expired patent to compete in the market as a generic you still need to prove you made it safely and that it works effectively.
bioequivalent (i.e., performs in the same manner as the innovator drug).
They have to be bioequivalent! Generics have to work the same as the original drug when it was created.
If they get ANDA approved generic can go to market.
Over the Counter Drugs
Over counter drugs go through a separate process Over-the-Counter (OTC) Drug Review (OTC monograph) process.
Biologic License Application (BLA)
Now drugs have become really complicated proteins and gene threapy require a different application and approval process
- Monoclonal antibodies for in-vivo use
- Cytokines, growth factors, enzymes, immunomodulators; and thrombolytics
- Proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of these products (except clotting factors)
- Other non-vaccine therapeutic immunotherapies
So now you know how drugs get to market its long complicate and expensive process but its worth it because drugs are safe to consume for average person.