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How The FDA Approval Process Contributes To Defective Drugs



Before a pharmaceutical drug is approved by the FDA, a lengthy and complex drug approval process is involved. After a pharmaceutical manufacturer develops a new drug, it undergoes a lengthy laboratory testing process before approval is granted by the FDA to progress to clinical trials.

The FDA Drug Approval Process

Before clinical trials are authorized, a New Drug Application (NDA) must be submitted to the FDA for review. The NDA outlines the results of pre-clinical testing and sets forth a proposed clinical study protocol. The FDA is required to review the NDA within 30 days of its submission. If the FDA does not disapprove the application within the 30-day time period, the drug progresses to a Phase I clinical trial.

During the initial drug development process, studies are conducted by the drug's sponsor, usually a pharmaceutical company. Information is obtained concerning possible adverse side effects or serious complications associated with the drug. Initial research testing is required prior to proceeding to clinical trial studies.

The Clinical Trial Process

Clinical trials involve extensive research studies conducted on humans for the purpose of determining the safety and efficacy of new drugs before they are submitted to the FDA for approval. The clinical trial process is separated into four phases.

  • Phase I trials are conducted as a preliminary evaluation of the drug's safety for use on humans.
  • Phase II trials are conducted to determine the effectiveness of the drug and to screen participants for common side effects.
  • Phase III trials are conducted to ascertain the drug's effectiveness, safety, benefits and potential adverse complications.
  • Phase IV trials are known as post-marketing safety studies. These studies are conducted after the FDA has granted approval of the drug. The goal of post-marketing studies is to monitor the long-term safety and efficacy of the drug.

Detection Of Defective Drugs Following FDA Approval

Most drugs are approved by the FDA following the completion of Phases I through III. Phase IV studies are used by the FDA to gather additional information concerning the drug's safety and to establish a system through which to monitor reports of serious complications associated with the drug. The FDA has the ultimate responsibility to review all study data collected during clinical trials prior to granting marketing approval. In the event the pharmaceutical company misrepresents study data or withholds negative information, the FDA can grant approval based on erroneous information. Unfortunately, once a drug has been approved for marketing, information concerning adverse complications and fatalities is handled as an investigation, which can take several years to resolve.

Many serious complications are not discovered until after a new drug has been marketed to consumers. Recent post-marketing studies have revealed life-threatening complications associated with drugs such as Actos, Januvia, Byetta and Pradaxa. If serious complications are reported to the FDA, investigative actions can be taken, including the temporary removal of the drug from the market, or misbranding of the medication, as in the case of Januvia.

The FDA 30-day time period for "disproving" a new drug application has resulted in many drugs being summarily passed through to the clinical trial process. Despite regulatory safeguards and study protocols, many drugs are approved by the FDA without properly-conducted clinical trials, resulting in serious medical consequences and fatalities. It has become obvious that multi-national pharmaceutical companies have more power than the regulatory agencies responsible for protecting the safety of consumers.

Defective Drug Lawyers

If you have suffered serious complications or injuries after taking a defective drug, you have legal rights. You may be entitled to financial compensation for reimbursement of past, current and future medical expenses. You may be entitled to reimbursement for lost wages and potential loss of future earnings. Your defective drug lawyer can guide you through the legal process and assist you to obtain the compensation you deserve.