The Pros And Cons Of The FDA

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According to its mission statement, the FDA is responsible for“protecting public health by assuring the safety, efficacy, and security of human. Specially, after the well-known Thalidomide tragedy in Europe. Based on (21 U.S.C. section 331) the Food, Drug, and Cosmetic Act (FDCA) prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs that lack FDA approval, whether for personal use or otherwise, violates the Act. As a result, the importation of unapproved medications from outside the U.S. is prohibited. Overall, the FDA regulates more than $2 trillion worth of consumer goods, which is no small task. The FDA is keenly aware that it cannot provide adequate assurance that drug products …show more content…
Based on this incident, Sally who is a patient with liver cancer, she has been given 6 months to live. She started to search for any promising treatment which would give her hope to live more and improve her condition. She has been advised to start a medication which is manufactured in Europe and not approved by the FDA. Based on the previously mentioned incident, she has the right to get the FDA approval to import the required medication to treat her condition. Also, based on The Regulation Procedures Manual (RPM) under the entitled section “Coverage of Personal Importations,” which states the FDA should consider not taking enforcement actions against certain cases of importation, specifically when the intended use of the drug is unapproved and for a serious condition as in Sally's case for which effective treatment may not be available domestically either through commercial or clinical means. Also, when the product is considered not to represent an unreasonable risk. Moreover, when the individual seeking to import the product affirms in writing that it is for the patient's own use under the recommendation and the supervision of the health care provider. Although the PRM provides that the importation should generally not
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