The Federal Drug Administration (FDA) has an immense responsibility to regulate everything from bottled water to prescription drugs and beyond to vaccines and cigarettes. In order to successfully fulfill their duties, the FDA spends months evaluating and proposing regulations for new products or drugs. The process is not a straight path from evaluation to regulation. Instead, it follows a cyclical path of proposal, modification, and re-proposal until, finally, they reach a decision on the product and create regulations.


The FDA approval process

The time between the development of a new drug and FDA approval can be extensive. Before the FDA ever gets involved, scientists must develop and test a drug on animals, after which point a drug company becomes involved to design a prototype of the drug.

This same drug company must then file an Investigational New Drug (IND) application with the FDA. This is permission to hold clinical trials using humans. After completing a trial, the research and all information gleaned from the clinical trials is submitted to the FDA for final approval. If approved, the drug is then allowed to be marketed to the general public.


Regulating new drugs

The FDA only approves drugs if they are deemed both safe and effective for their intended purpose. The manufacturing plant that produces the drug must pass a rigorous safety inspection and the drug must be labeled correctly, meaning it is prescribed for the conditions it was intended to treat. Once approved, the FDA is responsible for regulating the drug, This includes ensuring that the drug is labeled appropriately and isn’t causing adverse reactions with consumers.


The components of regulation

The FDA regulates new drugs through a multi-tiered activity record that takes into account:

  • product integrity
  • labeling
  • reporting
  • surveillance
  • drug studies
  • risk management
  • information dissemination
  • off-label use
  • direct-to-consumer advertising

The regulation process is continual and can have many consequences for drug companies. From changes to the way the drug is marketed to label changes or warnings to a drug being pulled from the market entirely, the actions of the FDA control the fate of medications across the country.


Label warnings

The FDA requires drug companies to label prescription and over-the-counter medications to let consumers know possible adverse effects and contraindications. Some drugs cause dizziness or drowsiness and cannot be used before driving a vehicle; others may not mix with over-the-counter drugs and cause adverse reactions or minimize the drug’s effect.

A black box warning is the strictest labeling tool used by the FDA and is intended to warn consumers of serious or fatal effects of the drug. Most modern prescription anti-depressants include a black box warning that youth and teens are at an increased risk for suicide with use.

Other drugs warn of the potential for heart failure, fetal birth defects if used during pregnancy, or cancer risk. Fourteen percent of changes in labeling that the FDA dealt with between 2005 and 2008 originated due to a revision or change in a black box warning.


Implications of labeling

It is estimated that doctors may ignore or violate the black box warnings in 7% of prescriptions given to patients. This can result in an increase in dangerous, often fatal, side effects of black box drugs. In some cases, drugs with black box warnings can lead to potentially large lawsuits, as has been the case for drugs like Xarelto, Zofran, and Risperdal among others.


Additional reading

Here are some additional resources to learn more about the FDA:


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