Final answer:
In the Daubert v. Merrell Dow Pharmaceuticals, Inc. case, the U.S. Supreme Court assigned the role of the gatekeeper to the trial judge, who is responsible for determining the admissibility and reliability of scientific evidence in court.
Step-by-step explanation:
In the case of Daubert v. Merrell Dow Pharmaceuticals, Inc., the U.S. Supreme Court designated the trial judge as the gatekeeper for the admissibility and reliability of scientific evidence. The trial judge is responsible for determining whether the evidence presented is pertinent, reliable, and adheres to a scientifically valid method. A judge must consider if the individual providing testimony is an expert in the relevant field, whether there is consensus among other experts in the field, if the testimony reflects the consensus, and if the expert might be biased.
The adversarial judicial system requires that both parties in a case share evidence with each other through a process known as disclosure. Under the Daubert standard, the trial judge must ensure that the scientific evidence is not only relevant to the case but also that the methodology used to produce the evidence is scientifically sound and has gained acceptance within the scientific community.
As for the impact of governmental regulations on pharmaceuticals, while entities such as the Food and Drug Administration (FDA) ensure drug safety and efficacy, thereby protecting consumers, the more anonymous losers in this system are the companies and individuals affected by the lengthy and costly drug approval process, potentially delaying access to new treatments.