Viewpoint: 4 reasons the FDA should ditch the pass/fail drug approval process

The Food and Drug Administration should eliminate its approve/disapprove method of reviewing new drug applications and instead use a Consumer Reports approach that is based on drug ratings, according to a column in the Wall Street Journal by John Sotos, MD, worldwide medical director at Intel.

Dr. Sotos believes the FDA should issue letter grade ratings of a drug's safety, efficacy and the degree of evidence supporting safety and efficacy. The FDA would make all drugs — excluding those demonstrating serious safety concerns — available to consumers and allow companies to increase their ratings through continued research and development. Patients and physicians could then rely on these ratings as a starting point to decide which medication to use. While the FDA would seemingly morph from a regulatory agency into an information arbitrator, the agency would still hold the power to keep drugs off the market in all necessary situations.

Here are four reasons Dr. Sotos advocates for this change in the FDA's drug approval process:

  1. This approach would allow drugs to reach the market faster, before all the required clinical trials for a drug are finished. A drug with a low degree-of-evidence score would be a welcomed treatment possibility for patients with a life-threatening illness and no other options. Drug companies would also jump at the opportunity to monetize their research investment at an earlier stage, although they would have to commit to the drug's continued manufacturing.

  1. The system would drive drug makers to conduct more clinical trials to achieve higher evidence ratings and become more attractive to patients and physicians. This motivation factor would also fix the current issue regarding the lack of post-market drug studies currently available to physicians.

  1. The strategy could help physicians make better decisions when it comes to patient care. If the FDA relied on a standard vocabulary to define which patients would be eligible to take what drugs based on ratings, EMRs could automatically match a patient to the corresponding FDA ratings, finding the ideal drug for the individual. Patients could also gain a better understanding of the physician's prescribing decisions and be more involved in the decision making.

  1. This graded drug approach compliments the changes facing the drug market today. The future of the drug market lies with new treatments that are targeted for small groups of patients, a phenomenon we're currently seeing in the cancer drug market. Just as ratings draw distinctions from the millions of mobile apps available for technology users today, so too would detailed drug ratings help physicians and patients select the best possible medication for the individual.

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