The Kefauver-Harris Drug
Amendment Act was ratified initially in 1962. Discuss the effect of the amendment and why you believe this law so severely criticized. As a Christian administrator, discuss your ideas for implementation of this law.
Current Issues and Trends
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Current Issues and Trends
The Kefauver-Harris Drug Amendment was signed into law in 1962 by the then US president John F. Kennedy. The legislation established the basis used by the Food and Drug Agency today, which ensures that the drugs sold to the consumers are not only, safe but also effective in treating the indicated conditions (Ellenberg, 2017). Before the legislation, the FDA did not have any authority on controlling drugs resulting in the streaming of uncontrolled drugs into pharmacies and patients’ bedside tables. More so, patients were being misled by extravagant advertisement claims, which prompted the legislator to come up with the amendment to prevent the devastation that was caused by thalidomide among mothers after being administered for morning sickness in other countries such as children being born without or with flipper-like upper and lower limbs.
The amendment introduced changes, which include requiring the drug manufacturers to prove the effectiveness of a drug before it is released to the market and at the same time report any adverse effects on the patients (Ellenberg, 2017). The FDA should be provided with evidence of well-controlled trials of a drug and the study subjects be required to consent before engaging in any trial. The FDA was given 180 days to approve any application of a new drug before it could be marketed in the US; the FDA was allowed to evaluate drugs for their safety, and set manufacturing prices while at the same time was given the mandate and responsibility of advertising drugs as well as providing accurate information on the drugs’ side effects.
The Kefauver-Harris Drug Amendment of 1962 has had a huge impact on the pharmaceutical industry by facilitating a drug review process, which has been considered a gold standard. Abiding by the law allows the Federal Drug Agency to ascertain that drugs go through a rigorous process hence evaluating their safety, effectiveness, and quality. The amendment has resulted in better drug labeling allowing the patients to understand comprehensively the effectiveness of the drug in managing their conditions while at the same time being aware of the possible side effects that they could experience upon administration of the drug. In addition, the use of controlled trials ensures that the pharmaceutical companies conduct quality tests hence an in-depth evaluation of drugs, their pharmacodynamics, and pharmacokinetics as well as effectiveness and safety for use among persons of different genders, ages, and races.
Despite the positive strides that the law has made in streamlining the pharmaceutical industry and promoting patient safety, it has faced severe criticism from different quarters. Some negative views about the law are that it causes high drug prices as well as delayed drug approvals. Critics of the law assert that it resulted in a costly drug development process where the drug companies end up charging high prices to the generic competitors since they enjoy patent protection and need to recover the outlays. The high and strict regulation of the drug industry continues to push potential drug developers away resulting in high drug prices. The critics claim that eliminating the strict regulations that were introduced by the Kefauver-Harris Drug Amendment would make the process of introducing new drugs into the market easy and subsequently result in a decrease in drug prices due to the presence of competitors in the market.
The criticism also touches on the disappearance of some medications from the markets. Before the law drugs could be approved for use based on their safety data and therefore, due to the lack of resources by the companies to conduct clinical trials to prove their effectiveness, the drugs were taken off the market (Kinch et al., 2018). The lack of standard market approval allowed some manufacturers to enjoy the monopoly of production.
As a Christian, administrator, some of the ideas that I would propose for the implementation of this law would be an expansion of financial incentives to cater to the costs of clinical research, especially for orphan products. Patients with rare diseases have limited access to medication due to the limitations of making profits on the drugs for a small population of people. The financial incentives would encourage more pharmaceutical companies to develop orphan drugs, having done adequate research and clinical trials to support the approval of such medication for rare diseases.
More so, I would encourage the production of more generic drugs. It is important to note that the generic drug companies do not have to necessarily repeat the clinical trials that the brand companies have done. They must however show that the drugs that they produce are equivalent to those being produced by the brand companies in terms of therapeutic effects. The introduction of more generic drugs into the healthcare sector is likely to alleviate the high cost of drugs, which is a concern to many Americans. The high cost of prescription drugs in the US has been associated with inequalities among people from different social-economic classes, misuse of drugs, and deteriorated health among the population.
References
Ellenberg, S. S. (2017). Discussion: Is the FDA in need of a major change in the way it regulates?. Biostatistics, 18(3), 414-416.
Kinch, M. S., Kinch, G. A., & Griesenauer, R. H. (2019). Lost medicines: a longer view of the pharmaceutical industry with the potential to reinvigorate discovery. Drug discovery today, 24(2), 382–389. https://doi.org/10.1016/j.drudis.2018.09.006