Imagine that there were no Food and Drug Administration (FDA), but there remained a large pharmaceutical sector, similar in size and scope to the one the United States enjoys today. In this alternate world, imagine that drugs were officially not licensed; there were even officials in the executive branch who boasted that the U.S., unlike other countries, would not get into the regulatory morass of licensing drugs.
One day, a pharmaceutical developer warns that they think they have made a drug that cures a major Cancer at one dosage but is lethal at a slightly higher dosage. The company says, for this reason, that they are going to restrict release only to pre-approved patients and monitor their usage of the drug carefully—a sharp break from prior industry practice but one that the company insists, controversially, is necessary. This particular company had been advocating for years for stricter drug regulation, much to the chagrin of the government.
This causes a stir, and the government, not quite knowing what to do, announces that it will give drug developers the helpful option to show their drugs’ safety profiles to government officials before they are released. They are adamant that this is a voluntary program. The pharmaceutical company, being hopelessly literal nerds, and if we are being honest, more than a little bit obstinate, decides to release their drug without going through the voluntary program. “We already paused general availability of the drug while we did our own safety study, so we don’t need the government’s testing, and besides it is voluntary, isn’t it?” the company seems to be saying.
