Should Drug Companies Have to Run Extra Tests When the Answer Is Already Known?

Many patients in the United States and around the world cannot afford the medicines they need to treat serious illnesses like cancer and autoimmune diseases. One scientist says a key reason for this is that drug companies are forced to run expensive tests that may not be necessary. Dr. Sarfaraz K. Niazi, a pharmaceutical scientist and professor, is calling on the U.S. Food and Drug Administration — known as the FDA — to stop requiring those extra tests when strong scientific evidence already shows that a drug is safe and effective.

The drugs at the center of this debate are called biologics and biosimilars. Biologics are powerful medicines made using living cells. They are used to treat some of the most serious illnesses people face, including certain cancers and autoimmune disorders. Biosimilars are copycat versions of biologics. The FDA says biosimilars must be highly similar to the original drug, with no meaningful differences in safety or effectiveness.

The problem is that creating a biosimilar is still very expensive. Drug companies must run many tests before the FDA will approve a new biosimilar. Some of those tests, called clinical trials, involve giving the medicine to human volunteers to collect data. Dr. Niazi argues that some of these trials are not adding new information — scientists already have the answers they need from other types of testing. Running those extra trials anyway wastes money, takes years, and keeps cheaper medicines away from patients who are suffering.

To explain his point, Dr. Niazi uses a simple comparison. Imagine weighing a diamond on a high-precision scientific scale, then weighing it again on a bathroom scale. The second measurement does not make the result more accurate — it actually adds confusion. He says requiring extra drug trials when modern science has already answered the question is the same kind of mistake. Today's tools can examine a drug's molecular structure, how it moves through the body, and whether it could cause a dangerous immune reaction — all without putting more people through a clinical trial.

The FDA has already taken some steps in the right direction. In March, the agency released draft recommendations to simplify certain testing requirements, estimating savings of up to 50 percent in study costs, or about $20 million per drug. In October 2025, the FDA also suggested that some large comparison studies may not be needed if other evidence is strong enough. Dr. Niazi says these are good first steps, but they are not enough because they are only draft guidelines, not firm rules that companies can count on.

The cost of unnecessary trials goes far beyond the price tag. When development costs are very high, smaller companies often cannot afford to enter the market, which means fewer competitors and higher prices. The people most hurt by this are patients who are uninsured or underinsured. According to the World Health Organization, about one-third of people on Earth do not have regular access to essential medicines, and for advanced biologic treatments, the problem is even worse.

Dr. Niazi points to history as proof that change is possible. When genetic engineering was first introduced, many people feared it and predicted disaster, but over time biotechnology advanced and new medicines became widely available. He believes biosimilars can follow the same path if regulators modernize their rules. When more manufacturers compete in a market, prices fall and more patients get the treatment they need.

Dr. Niazi says the FDA and other regulators around the world should work together to create clear, science-based guidelines that remove unnecessary tests while keeping those that protect patient safety. Drug companies should invest in better analytical tools and be transparent about their evidence. Patient groups and lawmakers should push regulators to measure success by how safe and accessible medicines are — not simply by how many tests were completed. The goal, Dr. Niazi says, is a system that serves patients first.