History, status, and politicization of the FDA
| Autor: | Albert I. Wertheimer, Will Wang |
|---|---|
| Rok vydání: | 2022 |
| Předmět: |
Drug
medicine.medical_specialty Drug Industry media_common.quotation_subject Scopus Pharmaceutical Science Pharmacy 030204 cardiovascular system & hematology Eteplirsen Food and drug administration 03 medical and health sciences 0302 clinical medicine medicine Drugs Generic Humans Medical prescription Prescription Drug User Fee Act Drug Approval health care economics and organizations Pharmaceutical industry media_common United States Food and Drug Administration business.industry Public health Advertising United States Pharmaceutical Preparations Business 030217 neurology & neurosurgery |
| Zdroj: | Research in Social and Administrative Pharmacy. 18:2811-2816 |
| ISSN: | 1551-7411 |
| DOI: | 10.1016/j.sapharm.2021.06.009 |
| Popis: | The Center for Drug Evaluation and Research (CDER) performs an essential role in public health by ensuring, evaluating, and monitoring the safety and efficacy of drugs before they are sold in the US. Before approving new drug applications, CDER ensures that therapeutic benefits of both prescription and over-the-counter drugs (brand name and generic) provide more health benefits than the potential risks. First passed by Congress in 1992, the Prescription Drug User Fee Act (PDUFA) allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund new drug approvals. The law allowed the FDA to expedite drug approvals, but possibly lowered standards for safety and brought potential conflicts of interest within the FDA and pharmaceutical industry. To examine the conflicts of interest, we conducted a review using the Excerpta Medica database, US National Library of Medicine National Institutes of Health Database (PubMed), Scopus, and Google. Our search yielded Vioxx (rofecoxib) and Exondus-51 (eteplirsen) as examples of consequence when the FDA and pharmaceutical industry are too closely aligned. We further examine how the pharmaceutical industry may indirectly influence the FDA by lobbying to Congress or directly by hiring ex-FDA commissioners. |
| Databáze: | OpenAIRE |
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