A History of the FDA & Drug Regulation in the U.S.

<div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEipqUinyPsfK_8cQVcYk19JdAvB9V4NntCyJ2kGUTYoo9Iwv5-GAXvUs66xHAfCDCsnYy1oT9YgCI4ntiZFS8N80tK7tii55OQTKOfggEG-BKjJAYcX910EcysxexCdynXfK2eKZzddgb96/s1600/2000px-Food_and_Drug_Administration_logo.svg.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="274" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEipqUinyPsfK_8cQVcYk19JdAvB9V4NntCyJ2kGUTYoo9Iwv5-GAXvUs66xHAfCDCsnYy1oT9YgCI4ntiZFS8N80tK7tii55OQTKOfggEG-BKjJAYcX910EcysxexCdynXfK2eKZzddgb96/s1600/2000px-Food_and_Drug_Administration_logo.svg.png" width="640" /></a></div><table style="width: 100%;"><br> <tr> <th>Year</th> <th>Act</th> <th>Purpose</th> </tr> <tr> <td>1906</td> <td>Food and Drug Act</td> <td>Outlaws states from buying and selling food,drinks, and drugs that have been mislabeled and tainted.</td> </tr> <tr> <td>1912</td> <td>Sherley Amendment</td> <td>Outlaws labeling drugs with fake medical claims meant to trick the buyer.</td> </tr> <tr> <td>1930</td> <td>FDA</td> <td>Food and Drug Administration is named.</td> </tr> <tr> <td>1938</td> <td>Federal Food, Drug, and Cosmetic (FDC) Act of 1938</td> <td>Requires new drugs to be proven safe prior to marketing; starts a new system of drug regulations; requires safe limits for unavoidable poisonous substances; and allows for factory inspections. </td> </tr> <tr> <td>1951</td> <td>Durha-Humphrey Amendment</td> <td>Defines the type of drugs that cannot be used safely without medical supervision and limits the sale to prescription only by medical professionals.</td> </tr> <tr> <td>1962</td> <td>Kefauver-Harris Drug Amendments</td> <td>Requires manufacturers to prove that their drug are effective prior to marketing.</td> </tr> <tr> <td>1972</td> <td>Over-the-Counter Drug Review </td> <td>Nonprescription medications must be safe, effective and appropriately labeled.</td> </tr> <tr> <td>1982</td> <td>Tamper-Resistant Packaging Regulations</td> <td>Makes it a crime to tamper with packaged products and requires tamper-proof packaging.</td> </tr> <tr> <td>1984</td> <td>Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)</td> <td>Allowed FDA to approve generic versions of brand-name drugs without repeating research to prove safety and efficacy; allowed brand-name drugs to apply for up to 5 years of additional patent protection for new drugs make up for time lost while their products were going through the FDA approval process</td> </tr> <tr> <td>1988</td> <td>Prescription Drug Marketing Act</td> <td>Designed to eliminate diversion of products from legitimate channels of distribution and requires wholesalers to be licensed.</td> </tr> <tr> <td>1997</td> <td>Food and Drug Administration Modernization Act</td> <td>Expands scope of agency activities and moves agency to the Department of Health and Human Services (DHHS)</td> </tr> <tr> <td>2003</td> <td>Medicare Prescription Drug Improvement and Modernization Act of 2003</td> <td>Includes Medicare Part D which increases access to medications through private insurers.</td> </tr> </table><b> </b><br /> <b>Adapted from U.S. Food and Drug Administration, Center for Drug Evaluation and Research</b><br /> <b> </b> <iframe height="410" src="https://quizlet.com/81180278/flashcards/embedv2" style="border: 0;" width="100%"></iframe>

A History of the FDA & Drug Regulation in the U.S.

Year Act Purpose 1906 Food and Drug Act Outlaws states from buying and selling food,drinks, and drugs...

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