Government regulation is stifling America’s vibrant pharmaceutical industry. A recent report by the President’s Council of Advisors on Science and Technology estimates that it costs an average of $1.2 billion to win FDA approval and bring a new drug to market. Given that biopharmaceuticals account for roughly two percent of the economy, this is no small matter.
The chief problem is the complex process of clinical trials, in particular “Phase 3,” in which a drug is tested and retested to prove its its effectiveness in treating conditions across a broad population. These trials have a strong track record, but they are poorly suited to new biopharmaceuticals, which are often very effective in smaller, targeted groups despite a lower success rate in the public at large. Under the current system, many of these drugs may fail their trials despite their effectiveness when prescribed correctly.