The evolution of health care and pharmaceutical regulation in this country began prior to the creation of the Food and Drug Administration (FDA). Throughout history there have been key events that have occurred resulting in pivotal changes in health care regulation. From the formation of the FDA to the passing of the Patient Protection and Affordable Care Act (ACA), there has been a focus of safety and consumer protection as purpose for increased of health care regulation in United States.
Several events laid the groundwork for the formation of the FDA. It was theorized that many American soldiers lost their lives during the Mexican-American war due to the use of adulterated medications. The high mortality of American soldiers during the …show more content…
The absence of safety regulation was made evident by the Sulfanilamide disaster that caused 107 deaths in 1937 (FDA, p.5). As a result of the Sulfanilamide disaster, the Food, Drug, and Cosmetic Act (FDCA) was passed in 1938. The FDCA provided the provisions that drugs had to be proven safe before they could be marketed. It also added provisions that directions for safe use and warnings needed to appear on drug labels (FDA, p.5). The FDCA touched on the fact that drugs needed to be safe but did not specify who would determine if a drug was safe for a patient to take. Temin interprets the passing of the FDCA as the FDA’s indication that “people were no longer competent to administer some medicines to themselves and thus made doctors their expert agents”. Temin continues stating that the impact of who is the decider, of which medicines people take, has had enormous impact (Temin, p.5). According to Brennan and Berwick, one role of regulation is to “compensate for inadequate consumer information” (Brennan and Berwick, p.14). The FDA’s passing of the FDCA indicating people were no longer able to make competent decisions could be due to their inadequate information. Brennan and Berwick describe the scenario of a patient and doctor relationship, where the patient desires more information and due to the paternalistic relationship, the doctor’s response is “trust me” …show more content…
Donabedian focuses on “outcomes as the criterion of quality in medical care” (Donabedian, p.3). Even if more individuals obtained health insurance under the ACA, what outcomes are being measured to judge it as a successful program? One of the main contentions of the law is the mandate that all individuals have to have health insurance. If outcomes were used as a measure of the success of ACA rather than the percentage of individuals covered by health insurance, the overall effectiveness and quality of health care may be validated (Donebedian, p.4). Brennan and Berwick note that there is almost no information from articles or books that address the quality of medical care and there is little regulation of health care quality (Brennan and Berwick, p.3). One of the provisions in the ACA law was to address low health care efficiency and quality (Shaw, p.75). Perhaps the focus on the quality portion of the ACA is lost due to the sheer polarization of it being signed into
Several events laid the groundwork for the formation of the FDA. It was theorized that many American soldiers lost their lives during the Mexican-American war due to the use of adulterated medications. The high mortality of American soldiers during the …show more content…
The absence of safety regulation was made evident by the Sulfanilamide disaster that caused 107 deaths in 1937 (FDA, p.5). As a result of the Sulfanilamide disaster, the Food, Drug, and Cosmetic Act (FDCA) was passed in 1938. The FDCA provided the provisions that drugs had to be proven safe before they could be marketed. It also added provisions that directions for safe use and warnings needed to appear on drug labels (FDA, p.5). The FDCA touched on the fact that drugs needed to be safe but did not specify who would determine if a drug was safe for a patient to take. Temin interprets the passing of the FDCA as the FDA’s indication that “people were no longer competent to administer some medicines to themselves and thus made doctors their expert agents”. Temin continues stating that the impact of who is the decider, of which medicines people take, has had enormous impact (Temin, p.5). According to Brennan and Berwick, one role of regulation is to “compensate for inadequate consumer information” (Brennan and Berwick, p.14). The FDA’s passing of the FDCA indicating people were no longer able to make competent decisions could be due to their inadequate information. Brennan and Berwick describe the scenario of a patient and doctor relationship, where the patient desires more information and due to the paternalistic relationship, the doctor’s response is “trust me” …show more content…
Donabedian focuses on “outcomes as the criterion of quality in medical care” (Donabedian, p.3). Even if more individuals obtained health insurance under the ACA, what outcomes are being measured to judge it as a successful program? One of the main contentions of the law is the mandate that all individuals have to have health insurance. If outcomes were used as a measure of the success of ACA rather than the percentage of individuals covered by health insurance, the overall effectiveness and quality of health care may be validated (Donebedian, p.4). Brennan and Berwick note that there is almost no information from articles or books that address the quality of medical care and there is little regulation of health care quality (Brennan and Berwick, p.3). One of the provisions in the ACA law was to address low health care efficiency and quality (Shaw, p.75). Perhaps the focus on the quality portion of the ACA is lost due to the sheer polarization of it being signed into