Getting generic drugs approved
Drug companies must submit an Abbreviated New Drug Application (ANDA) and prove their generic drug is the same as its brand-name counterpart to get approved by the FDA.

All generic drugs in the United States are approved by the U.S. Food and Drug Administration (FDA). To get approval, a manufacturer must submit an Abbreviated New Drug Application (ANDA) and show that their generic drug is equivalent to the marketed brand name.

Manufacturers must adhere to the following ANDA guidelines:

  • The FDA will grant some time for exclusivity for the first application to meet all the proper requirements.
    • However, the manufacturer must wait for the branded drug’s patents or drug exclusivity to expire before launching their generic drug to pharmacies.
    • After the small window of exclusivity for the first approved ANDA, other generic manufacturers can have their applications approved and start shipping to pharmacies.
  • For the FDA to approve a generic version of a brand, the FDA requires that generic medications have the same dosage form, safety, strength, route of administration, quality, performance characteristics and intended use as the brand-name drug.
    • The generic manufacturing, packaging and testing sites must also pass the same quality standards as those of brand-name drugs.

Why are generic drugs cost-effective?

Generic drugs are cost-effective because the costs of research and development and drug discovery are not involved since the generic manufacturer can depend on the clinical data submitted by the innovator drug company for the medicine's safety profile.

Generic drugs are prescription medications that have the same active ingredients as their brand-name counterparts. They are expected to work like brand-name drugs in dosage, strength and performance, and must meet the same quality and safety standards. 

When patent protection for a drug with a brand name expires, the U.S. Food and Drug Administration (FDA) can approve a generic version of it for sale. The patent protection for a brand-name drug is usually 20 years from the date of the submission of the patent.

  • Because generic drug manufacturers don’t develop a drug from scratch, the costs to bring it to the market are lower.
  • On average, the cost of a generic drug is 80 to 85 percent lower than the brand-name drug.
    • Generic drugs save consumers an average of $8 to $10 billion a year at retail pharmacies.
    • Even more, billions are saved when hospitals use generics.
  • Not all brand-name drugs have a generic counterpart.
  • Drug companies can introduce generic versions only after they have been thoroughly tested by the manufacturer and approved by the U.S. FDA.

What is the process for getting a drug approved by the FDA?

The U.S. Food and Drug Administration (FDA) approval process for bringing a new pharmaceutical to market can span anywhere from 5 to 20 years. The process begins with: 

  1. Preclinical research
  2. Filing an investigational new drug (IND) application to initiate clinical trials examining efficacy and safety in humans
  3. Seeking regulatory approval with a new drug application (NDA)

Preclinical testing

  • During this phase of research, the toxicity, pharmacokinetics and metabolism of the compound are explored.
  • Drug properties, such as chemical makeup, stability and solubility, are established.

Investigational New Drug Application (IND)

  • After the preclinical research, the company submits an IND application.
  • The document covers all knowledge of the compound to date (drug manufacturing characteristics, chemical composition and behavior) and details of the intended plan for human trials.

Clinical trials

There are four phases here:

  1. Phase I: This involves about 20 to 100 volunteers or people with the target disease state.
    • This lasts over several months of targeted study, aiming to determine the safe acceptable dosages of the new drug.
    • Approximately 70 percent of drugs submitted for human trials will pass.
  2. Phase II: This involves a few dozen to 300 people.
    • This phase aims to determine the efficacy of the proposed medication and establish a list of side effects resulting from its administration.
    • The duration of this phase is between several months to up to two years.
    • Only 33 percent of drugs will pass.
  3. Phase III: Large-scale effort involving several thousand volunteers with the clinical condition the drug is aimed at treating.
    • The purpose here is the continued review of the drug's safety and efficacy.
  4. Phase IV: Participants are usually between 300 and 3000 volunteers who have been diagnosed with the condition targeted by the drug.
    • The purpose is to further establish efficacy and monitor adverse reactions associated with drug use.
    • Screening is more stringent and only about 20 to 25 percent of drugs, which enter phase III trials, will move on to this next phase of clinical testing.

NDA application

  • The FDA review teams submit evaluation reports with recommendations to the FDA’s administrative department (the administrative body responsible for approving or rejecting the NDA).

Drug labeling

  • The FDA will also review the labeling and packaging of a potential new drug to ensure appropriate and accurate information is being communicated to both healthcare personnel and regular customers.

Facility inspection

  • An FDA team visits the site where the drug will be manufactured to inspect the production facilities.
  • This is a routine part of the drug approval process.

After fulfilling all these steps, the FDA approves the drug.

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Medically Reviewed on 8/2/2021
References
U. S. Food and Drug Administration. What Is the Approval Process for Generic Drugs? https://www.fda.gov/drugs/generic-drugs/what-approval-process-generic-drugs

National Institutes of Health. How Are Drugs Approved for Use in the United States? https://www.nichd.nih.gov/health/topics/pharma/conditioninfo/approval

Dabrowska A, Thaul S. How FDA Approves Drugs and Regulates Their Safety and Effectiveness. Congressional Research Service. https://fas.org/sgp/crs/misc/R41983.pdf