Why Do Pharmaceutical Drugs Fail to Get Approval

The length of time that it takes for drugs to be approved, or whether they are approved at all, affects stakeholders. These stakeholders include patients who may benefit from the drugs, potential investors who shore up the pharmaceutical industry, and the companies themselves that decide which areas of R&D to pursue.

According to Zuzanna Fiminska of Eye for Pharma, fifty percent of new drugs have failed to get approval over the past 12 years. Only one in six drugs completes the stringent testing process that can take up to eight years from beginning to end. Many drugs fail because they cannot be commercialized successfully, they are not considered safe or effective, or the science applied in the testing process is inadequate.

Understanding why drugs fail has been the motivation for Leonard V. Sacks, leading author of a study on the delay and denial of drug applications and the FDA approval process. Sacks findings reflect the current state of pharmaceutical R&D.

  • Approval rates vary among disease groups – over 70 percent for oncology and 30 percent for pulmonology and allergy drugs. For some groups, it is easier to find patients or to determine the outcome of testing. Drugs with a greater effect are easier to confirm and, for life-threatening diseases, a certain level of concern with a drug might be tolerated.
  • The statistics concerning approval rates affect investment. Disease areas that see more drugs approved are more likely to see investment. Companies are more likely to invest in R&D for disease groups with higher drug approval rates.
  • Drugs may fail because of safety, efficacy, quality, and labeling concerns. Companies also face complications in getting drugs approved in the European market versus the US market. Different dosing is often advocated by the European Medical Association.

Often, the science is at fault. The studied population may not reflect the real population that may use the drug, end points may not meet FDA standards, or the drug may be inferior to existing treatments. Drugs can fail in late-stage development because they are considered unsafe or ineffective, or the quality of the product cannot be determined by the application data.

An inadequate study population can be ascribed to strict regulations that limit participants, such as the exclusion of pregnant women and children in most studies. Therefore, a balance must be found between ineffective trials and the need to meet stringent regulations. Sack concludes that loosening regulations would allow diversification in study populations and increase the approval rate of new drugs.

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