FDA Approval Process | What is the FDA Drug Approval Process?

NEWS FDA Approval Process | What is the FDA Drug Approval Process?
  • puslished-byJordan Terry
  • publish-dateJune 23, 2020 @ 11:32 am
  • categoryPharmaceutical Products

The Food and Drug Administration FDA Approval Process

The United States Food and Drug Administration, the FDA, reviews and approves new prescription drugs and medical devices before companies can put them on the market. The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for ensuring that drugs sold in the U.S. are both safe and effective. While the FDA approval process is used to keep consumers safe, the government regulatory agency’s methodologies have garnered scrutiny. Many have argued that the agency’s processes are flawed and responsible for keeping lower-cost drugs off of the market.


What is the FDA Approval Process?

Pharmaceutical companies hoping to sell new prescription drugs, vaccines, and biologics in the United States must gain FDA approval. The FDA drug-approval process involves five steps:

  1. discovery/concept
  2. preclinical research
  3. clinical research
  4. FDA review
  5. FDA post-market safety monitoring


FDA researchers work to determine if a drug is safe if the benefits outweigh risks, and if the drug-manufacturing process ensures a consistent, quality product.


At the beginning of the approval process, the company must conduct its own laboratory tests. This involves testing on animals and then humans to ensure that the drug is safe. After confirming the drug’s efficacy and safety, the company submits a New Drug Application (NDA) to the FDA. The NDA must include test results, manufacturing information, data from lab tests and studies, and the company’s proposed label for the drug (including usage instructions, effective dosage, and potential risks). FDA scientists and researchers then review the company’s submitted labeling, information, and research. This is when the agency determines if the findings prove that the drug meets the safety and quality metrics listed above (benefits vs. risks, manufacturing processes). Note that the agency itself usually does not test drugs before making a decision, but it does inspect the drug-manufacturing facilities. If the FDA determines that a drug meets its standards, the drug is approved for market in the United States. The FDA continues to monitor the drug for safety after the approval. Biologics and vaccines follow the same general approval process.


The FDA approval process exists to ensure consumers do not take unsafe prescriptions. Unfortunately, the FDA Process has been called into questioning for unsafe practices. FDA approval does not guarantee that a drug or medical product is safe, and the U.S. manufacturers recall thousands of products and prescriptions each year. If you believe that an FDA-approved drug led to adverse side effects or injuries, visit the Should I Report a Drug Injury or Drug Side Effect?’ page.



Generic Drugs and Generic Drug Approval

The Food and Drug Administration’s process for approving generic drugs is a bit different. Generic drug manufacturers do not need to repeat the same clinical trials conducted for the brand-name drug that they are replicating. The company submits an abbreviated New Drug Application (NDA) that contains the same steps as an NDA without the initial animal and human laboratory tests. Instead, generic drug manufacturers must prove that the drug is essentially the same as the brand-name drug. This includes verifying that the ingredients are as effective in treating the illness or condition as the brand-name drug is and that the generic drug produces the same reaction in the human body. After approval, generic drug manufacturers often still have to find a way around brand-name companies’ patents.



Drug Patents

Drug patents can make it difficult for generic drugs to make it to market. While generic-drug companies are allowed to work on drugs for FDA approval before the brand-name patent expires, the brand-name company has the legal advantage. Generic-drug manufacturers are required to notify the patent holder if they are challenging the existing patent; this includes claims that the patent is not valid or that the generic drug does not infringe on the brand patent. The brand-name company then has 45 days to respond. The company can file a suit against the generic-drug maker. If courts determine that the generic-drug infringes on the brand-names patent, the FDA cannot approve the generic drug for at least 30 months. Current U.S. drug patents are valid for 20 years from the date the application is filed. This makes it difficult for generic drugs to make it to market.  




“Pay-for-delay” agreements are another reason for lower-cost, generic drugs not making it to market. These agreements – also referred to as “reverse payment” agreements or “exclusion payment” agreements – are patent litigation settlements where a brand-name drug company pays the generic manufacturer to drop its patent challenge (see above) and keep its lower-cost product out of the market. This lets the brand-name company maintain high prices while potentially monopolizing the market. Pay-for-delay agreements hurt consumers who lose out on cheaper prescription drug prices. The Federal Trade Commission (FTC) reported that pay-for-delay agreements have significantly delayed substantial consumer savings for prescription drugs. In fact, the agency estimated that from 2010 to 2020, pay-for-delay agreements would cost American consumers $35 billion – $3.5 billion per year. The commission recommended that Congress pass legislation that protects consumers from the agreements. California became the first state to sign legislation against pay-for-delay agreements in October of 2019.  



Over-the-Counter Drugs Approval

Manufacturers of over-the-counter (OTC) drugs have several options when seeking FDA approval for market. OTC drug manufacturers can submit New Drug Applications and undergo similar procedures and standards as prescription drugs, vaccines, and biologics mentioned earlier. OTC manufacturers can also submit approval through the FDA’s OTC monograph. An OTC monograph specifies all FDA-accepted ingredients, formulations, testing parameters, and labeling for over 80 therapeutic classes of over-the-counter drugs. Manufacturers whose OTC drugs follow existing monograph specifications can go to market without additional FDA review. If an OTC drug does not fit a monograph, the manufacturer must submit a New Drug Application. The FDA regularly updates OTC drug monographs to include newly accepted labels and ingredients.  



Reporting Drug Injuries and Drug Side Effects

Many have argued that the FDA drug-approval processes are substandard or flawed. Just because a drug is FDA-approved does not guarantee that the drug will be risk-free. Manufacturers recall thousands of drugs every year in response to reported side effects, injuries, and other issues. Learn more about reporting drug injuries and drug side effects here


Fairness in Class Action Litigation Act

United States consumers deserve the right to hold drug companies accountable. For example, if you took a prescription medication that led you to develop stomach cancer, the manufacturer should be accountable. Unfortunately, members of Congress have introduced bills at the federal level design to strip away consumer rights and reduce pharmaceutical company accountability. The House Judiciary Committee passed a bill known as the Fairness in Class Action Litigation Act of 2017 – HR 985. The bill makes it harder for victims of bad drugs and their lawyers to take action against pharmaceutical companies. The bill is a transgression against consumers and their rights given by the 7th amendment, which states: “If someone harms you for the sake of profit, they should have to pay for the damages you endured because of your injury.” Read on to learn about the Fairness in Class Action Act to learn more about HR 985 and what can be done.



Injured By an FDA Approved Drug?

The FDA drug-approval process is designed to protect consumers from dangerous and adverse side effects. While the agencies’ regulations do increase safety and accountability, millions of Americans are at risk every year of complications, injuries, and even death from bad drugs. TorHoerman Law maintains a detailed list of current bad drug lawsuits. If you suffered any injuries or complications because of a bad drug, contact us today to learn more about your options.  





FDA Approval Process | What is the FDA Drug Approval Process?
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FDA Approval Process | What is the FDA Drug Approval Process?
What is the FDA Drug Approval Process? How are generic drugs approved? How are over-the-counter drugs approved? What is pay-for-delay? Read to learn more.
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TorHoerman Law
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