FDA Pharmaceutical Approval Process: An Overview | Audet & Partners, LLP

FDA Pharmaceutical Approval Process: An Overview

Mounting pressure from the pharmaceutical industry (Industry) has greatly influenced the drug approval process conducted by the U.S. Food and Drug Administration (“FDA”).  This pressure has led to the question of who the FDA is actually serving, the health and safety of the public or the Industry?

According to Sidney Wolfe, M.D., Director of Public Citizen’s Health Research Group, the Industry is exerting its influence on the FDA in three distinct ways:

  1. The Prescription Drug User Fee Act, passed in 1992, provides that pharmaceutical companies must pay a fee in order for the FDA to review their drug applications.  According to Dr. Wolfe, “This system has created a very unhealthy relationship between the industry and the FDA, where the FDA says, “We have to be nice to these people, because they are paying our bills.”
  2. The FDA concedes to what the Industry wants  in an attempt to avoid conflict.
  3. The absence of congressional oversight.  Prior to 2001, if a mistake was made, a congressional hearing was held, requiring the FDA to explain the situation to the legislative branch.  Currently, there are very few congressional hearings, and “no one is there in the Congress [now].”

The FDA states that its mission is to “…ensure that drugs marketed in this country are safe and effective.  The center’s best-known job is to evaluate new drugs before they can be sold.  The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.”[ii]

Can the FDA effectively and completely evaluate new drugs if the review and approval process is expedited?  This is of major concern as they continue to implement procedures for accelerating the review process to allow the Industry to begin selling drugs prior to a full and comprehensive review, with many studies being conducted after the drugs are already on the market.  “The public does benefit from the accelerated approval process.  For example, if a drug is potentially life saving and there is an immediate need, it could be useful to have the drug available sooner.”[iii]  However, this concept can be problematic when the Industry abuses it to get their drugs on the market faster.

The procedures[iv] that the FDA has implemented for accelerating the approval process are as follows:

  • Fast Trackexpedites the review of drugs to treat serious diseases and fill an unmet medical need.
  • Accelerated Approvalallows earlier approval of drugs to treat serious disease, and that fill an unmet medical need based on a surrogate endpoint (a marker – laboratory measurement, or physical sign – that is used in clinical trials as an indirect or substitute measurement that represents a clinically meaningful outcome, such as survival or symptom improvement).
  • Priority Review is for drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.  It means that the time it takes the FDA to review a new drug application is reduced.

These accelerated approval processes are disconcerting since the adequate amount of time necessary to thoroughly evaluate a drug is not being provided, which can lead to a potentially dangerous product with an FDA endorsement, being used by the public.  A poignant example of this is Avandia, manufactured by GlaxoSmithKline.  This drug is used to treat type 2 diabetes and received accelerated FDA approval.  Unfortunately, a study released after the drug was already on the market determined that it was linked to liver toxicity, heart attack, and a 43 percent increase in heart-related problems.  Subsequently, the FDA required that the drug be re-labeled with its most serious warning called a “black-box” warning.


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