| 来源类型 | Book
|
| 规范类型 | 其他
|
| Regulation of pharmaceutical innovation: The 1962 amendments |
| Sam Peltzman
|
| 发表日期 | 1974-06-01
|
| 出版者 | American Enterprise Institute
|
| 出版年 | 1974
|
| 语种 | 英语
|
| 摘要 | Download the PDF
Increasingly frequent reports about the availability abroad of drugs that cannot be sold in the U.S. have brought pressure on the Food and Drug Administration (FDA) to defend its regulation of the marketing of new drugs. Some of the drugs which cannot be sold here are the drugs-of-choice for foreign physicians in the treatment of certain conditions. Their failure to win the FDA’s approval for marketing here has provoked controversy among pharmacological experts. Further, the American rate of innovation in drugs has been lower following the passage of the landmark 1962 amendments to the Food, Drug and Cosmetic Act than it was before. Since these amendments established the framework of current FDA regulation of innovation, the extent to which this reduced rate of innovation can be attributed to the amendments has also been a matter of some controversy.
Inasmuch as the 1962 amendments were intended to prevent the marketing of some types of drugs, there may have been a net benefit from any regulatory-induced suppression of innovation. This study tries to shed light on the way the 1962 amendments have worked in practice. Have they produced more benefits, by preventing the marketing of ineffective drugs and providing additional information about new drugs, than any losses they have imposed by, for example, suppressing potentially beneficial innovation?
Food and Drug Regulation Federal regulation of the development and marketing of drugs goes back at least to the first decade of this century. The 1906 Food and Drug Act was the child of progressivism and of the legendary muckrakers. It was designed to protect consumers by requiring that a medicine’s ingredients be stated on a package label. There was no important restriction on the content or use of drugs. Today’s reader may find it curious that federal law deemed it adequate protection for the consumer if he simply knew “the quantity or proportion of any alcohol, morphine, opium, cocaine, heroin, . . . chloroform, cannabis … ,” and so on, contained in a medicine.
This posture was modified in the Food, Drug and Cosmetic Act of 1938, passed in reaction to the introduction of a liquid form of the drug sulfanilamide, whose solvent was discovered to be a lethal poison after commercial distribution began. The 1938 law forbade marketing of any new drug until the Food and Drug Administration approved a New Drug Application (NDA) submitted by the manufacturer. Before approval was given, the NDA had to demonstrate that the drug was “safe” for the use suggested on the label. The law provided for automatic approval of any NDA not rejected within 180 days. In practice the FDA was able to extend this period by requests for further information.
The most recent important change in regulation of the development of new drugs came with the 1962 amendments to the 1938 law. The primary feature of the 1962 amendments is that a manu- facturer must prove to the FDA’s satisfaction that a drug has the curative powers the manufacturer claims for it. The costs and benefits of this requirement are the subject of this study. |
| 主题 | Health Care
|
| 标签 | AEI Archive
; Cornerstone Content
; Drug policy
; drug safety
; FDA
; Pharmaceuticals
|
| URL | https://www.aei.org/research-products/book/regulation-of-pharmaceutical-innovation-the-1962-amendments/
|
| 来源智库 | American Enterprise Institute (United States)
|
| 资源类型 | 智库出版物
|
| 条目标识符 | http://119.78.100.153/handle/2XGU8XDN/207542
|
推荐引用方式
GB/T 7714 |
Sam Peltzman. Regulation of pharmaceutical innovation: The 1962 amendments. 1974.
|
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