By: Jonathan A. Knoll, Attorney

Two recent studies published by the British Journal of Medicine (BJM) raise concerns about the speed with which the Food and Drug Administration approves drugs for market in the United States. According to the FDA the stages of drug development and review necessary to gain marketing approval include:

  • Pre-clinical Testing;
  • Investigational New Drug Application;Fast tracked FDA approvals
  • Phase 1 studies – Focused on safety. Seeks to identify frequent side effects, etc.;
  • Phase 2 studies – Focused on efficacy. Does the drug work on the condition or disease?;
  • Phase 3 studies – A larger pool of subjects is tested for safety and effectiveness of drug;
  • Review Meeting between the Drug maker and FDA;
  • New Drug Application (NDA) – The formal step the drug maker takes in submitting all testing data to FDA for marketing approval.

When the NDA is submitted, the FDA has 60 days to decide whether to file the drug for review. The testing phases are potentially the longest timeframes involved with the drug approval process as it takes time to administer the drugs to the test subjects and gather safety and efficacy data. It can take several years for a drug maker to gather sufficient information from testing phase.

Fast-track Approval Process Geared to Help Patients

There are four programs available that allow the agency to expedite the development and approval process for new drugs: orphan drug- drugs used for diseases that affect very few people, fast track, accelerated approval, and priority review.

Regardless of the program used, expedited approvals are supposed to be reserved for drugs that are considered first in class and innovative enough to treat serious life-threatening illnesses that lack satisfactory treatments. However, when researchers from Brigham and Women’s Hospital and Harvard Medical School examined the FDA’s expedited drug development and approval programs between the years 1987 and 2014 they found quicker approvals were not necessarily granted to drugs defined by that criteria.

In fact, researchers found a 2.6% increase per year in the number of expedited review and approval programs during the timeframe studied. They noted these newly approved drugs did not always fit the requirement of being considered first in class or innovative.

Lack of In-Depth Testing Information Can Increase Patient Risk

One reason for the increase in expedited review and approval of drugs might be the passage of the Prescription Drug User Fee Act (PDUFA). This act was enacted in 1992 and authorizes the FDA to collect fees from companies that produce certain drugs and biological products for humans.

At the same time that the FDA increased the amount of drugs it approved through the expedited review process researchers with the Cambridge Health Alliance and Harvard Medical School conducted a study to examine black-box warnings and market withdrawals. These researchers found that drugs approved after the passage of the Prescription Drug User Fee Act were more likely to have a black box warning or be withdrawn from the market. These two findings would suggest that shorter approval times lack sufficient information to properly assess drug safety and efficacy and increase a patient’s health risk.

Drug Injury Lawsuits

When pharmaceutical makers push for expedited development and approval of products, patient safety could be compromised. Lawsuits have been filed against numerous drug makers who put profits ahead of patients by failing to disclose safety and efficacy information gathered during trial phases or failing to alert healthcare providers and the FDA of adverse events that occur once a drug has market approval. If you have suffered a serious injury after taking a prescription drug and would like to learn your legal rights, contact me.


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