A proposal that might allow safe, efficacious drugs to make it to market much faster, while also satisfying the safety concerns of the regulation enthusiasts:
"...recognize the drug approvals of, say, 15 other governments. That is, we reform the U.S. system so that if the drug-approval agency of even one of those 15 countries approves a drug for that country, then the drug is automatically approved in the United States.
So, for example, if Health Canada, that country’s counterpart to the FDA, approves a drug for Canada, then the drug would automatically gain approval in the United States. This 15 countries recognized would be, say, Britain, France, Sweden, Germany, Australia, New Zealand, Japan, South Korea, Switzerland, Spain, the Netherlands, Norway, Finland, Denmark, and Austria.
...
For example, in 2007, the FDA rejected Merck’s application for Arcoxia, a new inhibitor of an enzyme (COX-2) responsible for pain and inflammation. So, Americans do not have access to Arcoxia, while people in Germany and England do.
If American patients and their doctors decide that Arcoxia is the therapy that best meets the patients’ need, and the doctor is ready to provide a prescription, which would surely be required, should the United States government stand in their way? Under our proposal for drug-approval denationalization, the permission in Germany or England would work as permission in the United States."
Under this proposal, no single regulatory body would have monopoly control over the release of new drugs to the market. That way, if one regulatory body is captured and/or makes a mistake by blocking a new drug, the drug can still find a way to the market via a regulatory body that is not captured and/or mistaken.
Yet, truly quack medicines (homeopathy, etc) would only rarely make it through any of the regulatory body's processes.
https://www.econlib.org/library/Columns/y2009/Kleindrugapproval.html
"...recognize the drug approvals of, say, 15 other governments. That is, we reform the U.S. system so that if the drug-approval agency of even one of those 15 countries approves a drug for that country, then the drug is automatically approved in the United States.
So, for example, if Health Canada, that country’s counterpart to the FDA, approves a drug for Canada, then the drug would automatically gain approval in the United States. This 15 countries recognized would be, say, Britain, France, Sweden, Germany, Australia, New Zealand, Japan, South Korea, Switzerland, Spain, the Netherlands, Norway, Finland, Denmark, and Austria.
...
For example, in 2007, the FDA rejected Merck’s application for Arcoxia, a new inhibitor of an enzyme (COX-2) responsible for pain and inflammation. So, Americans do not have access to Arcoxia, while people in Germany and England do.
If American patients and their doctors decide that Arcoxia is the therapy that best meets the patients’ need, and the doctor is ready to provide a prescription, which would surely be required, should the United States government stand in their way? Under our proposal for drug-approval denationalization, the permission in Germany or England would work as permission in the United States."
Under this proposal, no single regulatory body would have monopoly control over the release of new drugs to the market. That way, if one regulatory body is captured and/or makes a mistake by blocking a new drug, the drug can still find a way to the market via a regulatory body that is not captured and/or mistaken.
Yet, truly quack medicines (homeopathy, etc) would only rarely make it through any of the regulatory body's processes.
https://www.econlib.org/library/Columns/y2009/Kleindrugapproval.html