Medicinal and Healthcare Regulation in the Us: an Overview of Major Events
Medicinal and Healthcare Regulation in the US: An Overview of Major Events
Regulation as we know it today, particularly in health care, is a relatively young concept. According to Brennan and Berwick in their book entitled New Rules they state “Though the roots of the regulatory state in this country can be traced to legislation passed in the middle and latter parts of the nineteenth century, regulation assumed its modern aspect in the years of the New Deal” (Brennan and Berwick, p.10). The New Deal encompassed the time period of 1933-1936, a time when our president was Franklin D. Roosevelt (FDR), and when our country was trying to recover from the Great Depression. During this time, new programs were created and implemented to help provide relief, recovery, and reform to better strengthen the country and its people for the future. New governmental agencies were creating during this time to help enforce new rules that were created to better serve popular public opinion at the time including the Social Security Administration, The Federal Deposit Insurance Corporation, and the Securities and Exchange Commission. Brennan and Berwick mention, however, that little of the new regulation affected the medical care industry (Brennan and Berwick, p.10). During this time period the Food and Drug Administration (FDA) was just in its infancy stages, but had little regulatory power.
As the 1930s continued on, there arose an increase in public demand for stronger regulatory authority when it came to food and drug products that were seriously injuring people. Products that claimed to cure diabetes or tuberculosis, among other things, were radioactive and causing health deterioration, yet were still available to the public due to lack of adequate regulation. In Temin’s words from his book, Taking Your Medicine, “The FDA tried to extend its legislative mandate during the early New Deal period, but not until a drug company had unwittingly produced a toxic preparation that
Regulation as we know it today, particularly in health care, is a relatively young concept. According to Brennan and Berwick in their book entitled New Rules they state “Though the roots of the regulatory state in this country can be traced to legislation passed in the middle and latter parts of the nineteenth century, regulation assumed its modern aspect in the years of the New Deal” (Brennan and Berwick, p.10). The New Deal encompassed the time period of 1933-1936, a time when our president was Franklin D. Roosevelt (FDR), and when our country was trying to recover from the Great Depression. During this time, new programs were created and implemented to help provide relief, recovery, and reform to better strengthen the country and its people for the future. New governmental agencies were creating during this time to help enforce new rules that were created to better serve popular public opinion at the time including the Social Security Administration, The Federal Deposit Insurance Corporation, and the Securities and Exchange Commission. Brennan and Berwick mention, however, that little of the new regulation affected the medical care industry (Brennan and Berwick, p.10). During this time period the Food and Drug Administration (FDA) was just in its infancy stages, but had little regulatory power.
As the 1930s continued on, there arose an increase in public demand for stronger regulatory authority when it came to food and drug products that were seriously injuring people. Products that claimed to cure diabetes or tuberculosis, among other things, were radioactive and causing health deterioration, yet were still available to the public due to lack of adequate regulation. In Temin’s words from his book, Taking Your Medicine, “The FDA tried to extend its legislative mandate during the early New Deal period, but not until a drug company had unwittingly produced a toxic preparation that
Cited: 1. Brennan, Troyen A., and Donald M. Berwick. "The Role of Regulation." New Rules: Regulation, Markets, and the Quality of American Health Care. San Francisco: Jossey-Bass, 1996. 1-30. Print. 2. FDA History- Part II. “FDA History.” FDA, 18 June 2009. Web. 23 Aug. 2012. <http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm054819.htm>. 3. FDA For Consumers. “Expanded Access and Expedited Approval of New Therapies Related to HIV/AIDS.” FDA, 11 September 2009. Web. 25 Aug. 2012. <http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm134331.htm>. 4. Hamowy, Ronald, “Medical Disasters and the Growth of FDA” 2010. 7-11. Print. 5. Mossinghoff, Gerald. "Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process." Food and Drug Law Journal. 54. (1999): 187-194. Print. 6. Temin, Peter. "Introduction." Taking Your Medicine: Drug Regulation in the United States. Cambridge, MA: Harvard UP, 1980. 1-17. Print. 7. Temple, Robert. "Policy Developments in Regulatory Approval." Statistics in Medicine 21.19 (2002): 2939-948. Print. 8. Vinci, James and Stempel , Jonathan. “US top court upholds healthcare law in Obama triumph.” Reuters. Web 25 August 2012. <http://www.reuters.com/article/2012/06/28/usa-healthcare-court-idUSL2E8HS4WG20120628>