Brad, More from the FDA
Found some interesting stuff on one of the FDA pages -
One page, titled "Benefit Vs. Risk: How FDA Approves New Drugs" had the following summary:
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Final Actions
In the final analysis, FDA's decision whether to approve a new drug for marketing boils down to two questions:
Do the results of well-controlled studies provide substantial evidence of effectiveness?
Do the results show the product is safe under the conditions of use in the proposed labeling? Safe, in this context, means that the benefits of the drug appear to outweigh its risks.
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The link to this page is:
fda.gov
It is very informative, with several jumps to detailed explanations of complex points.
I found another interesting piece of information on the following FDA page:
fda.gov
<<<One change FDA has adopted in recent years to speed drug review is categorizing new drugs as either standard or priority. Standard drugs are those that offer only minor improvement (or none) over drugs already on the market. Priority drugs, on the other hand--which may in fact be a new dosage form of, or new use for, an existing drug--are believed to represent potential major advances in health care. Distinguishing the two categories of drugs permits speedier review even before a new drug application is submitted.>>>
The interesting thing about these FDA "publications" is that neither of them specify that a new drug must show an improvement in efficacy over an existing one in order to get approved. The FDA is not in the business of selecting which drugs should be used. This is an MD's decision and is based on a raft of considerations. The agency is merely interested in whether a compound is safe & efficacious. If every drug had to be more effective than the one before it, there wouldn't be the number of anti-inflammatories, beta-blockers, etc. - there would be just one - the last one approved - and it would have the highest efficacy.
Pick the drug and there will be lots of approved compounds, each with its own profile from which the MD must select the one that best fits the patient's needs. |
