Pick two of the identified legislations topics below and explain their impact today.
1906
Food and Drugs Act: FDA is authorized to take action only after drugs sold to consumers cause harm.
1938
Federal Food, Drug, and Cosmetic Act: Evidence of safety is required before new drugs or devices can be marketed.
1962
Drug Amendments: FDA takes charge of reviewing efficacy and safety of new drugs, which can be marketed only once approval is granted.
1976
Medical Devices Amendments: Premarket review of medical devices is authorized; devices are grouped into three classes.
1983
Orphan Drug Act: Drug manufacturers are given incentives to produce new drugs for rare diseases.
1990
Safe Medical Devices Act: Health care facilities must report device-related injuries or illness of patients or employees to the manufacturer of the device and, if death is involved, the incident must also be reported to the FDA.
1992
Prescription Drug User Fee Act: FDA receives the authority to collect application fees from drug companies to provide additional resources to shorten the drug approval process.
1997
Food and Drug Administration Modernization Act: Fast-track approvals for life-saving drugs are permitted when their expected benefits exceed those of existing therapies.
Sample Answer
To understand the evolution of healthcare safety and innovation in the United States, one must look at how legislation shifted from a reactive stance to a proactive one. Below is an explanation of the 1938 and 1983 acts and their profound impact on today's medical landscape.
1. 1938: Federal Food, Drug, and Cosmetic Act (FD&C Act)
Before 1938, the government could only remove a drug from the market after it had already hurt someone. The FD&C Act was passed in response to the "Elixir Sulfanilamide" tragedy, which killed over 100 people because the drug contained a poisonous solvent.
The Impact Today:
The Concept of "Premarket Approval": This act established the foundational rule that a drug is "guilty until proven innocent." Today, no company can sell a new medication without first submitting scientific evidence of its safety to the FDA.
Birth of the Modern Prescription: This legislation allowed the FDA to determine which drugs were safe for self-medication and which required a doctor's prescription.
Standardized Labeling: It mandated that labels include adequate directions for use and warnings about habit-forming properties, which is why modern medication packaging is so detailed.
2. 1983: Orphan Drug Act
Prior to 1983, pharmaceutical companies focused almost exclusively on "blockbuster" drugs for common conditions (like heart disease or pain) because the cost of research and development for rare diseases was too high to be profitable. People with rare diseases were essentially ignored by the market.