The U.S. Food and Drug Administration (FDA) has an accelerated drug approval process to help make medications available to the public in an expedited manner. Once these drugs are fast-tracked onto the market, the drugmaker must perform a study to ensure the drug is effective and safe. If not, the drug is supposed to be recalled.
However, the accelerated drug approval process has not always panned out as expected. Drugmakers are not completing these additional studies. NPR studied 30 years of data to determine how these oversights have affected patients.
Effects of the fast-track process
Since drugmakers are not completing the necessary studies following the release of the drugs to the public, it raises questions about whether the drugs perform as promised. In addition, drugmakers are charging more over time for these fast-tracked drugs, despite not performing the mandated studies after the drugs are on the market. Moreover, it is difficult for physicians to know if a drug has been fast-tracked for approval as there are no regulations mandating disclosure of this process.
What happens if a dangerous drug is not recalled?
If a drug on the market turns out to cause significant, unknown side effects to patients, a recall can be issued voluntarily by the drugmaker or by the U.S. Food and Drug Administration (FDA).
The public is supposed to be notified of recalls, but this does not always happen. This means consumers might continue to use recalled drugs to their detriment.
In such situations, the consumer might have a products liability claim. Depending on the situation, a drugmaker might be held strictly liable for marketing medications that have unknown side effects or other undisclosed risks associated with taking the drug.
