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Fda Reform Advances - But Is It Enough?
Posted on 05/11/2007 07:19:41 | Link | Post Comment
by Mark S. Senak
Eye On FDA
Yesterday the Senate overwhelmingly voted on an FDA Reform package (93-1 vote) that is a legislative solution to many of the issues that have heavily tarnished the agency's once gold standard image. The bill is the much awaited "Kennedy-Enzi" bill, also known as The Enhancing Drug Safety and Innovation Act of 2007. Now, the House will take up matters and when passed, it will go to the White House later this summer.
But the reform packaged in the bill is only a solution to the extent that a lack of authority was the problem. After all, up until 6 years ago, the agency did fine without these added powers.
That is not to say that the legislation is not needed - it is. In fact, the agency probably needs more authority than given in the context of this bill.
But what looks to be the eventual passage of the bill should not signal that the problems are now addressed. How those reforms are employed matters every bit as much as having them to execute. This should be viewed as a process and not an event - and FDA reform legislation is only the beginning of that process.
Source: EyeOnFDA.com
RELATED READING:
- Loading Up the PDUFA Cart
- Food Safety: FDA Communications During Crisis
___________________
Eye On FDA
Yesterday the Senate overwhelmingly voted on an FDA Reform package (93-1 vote) that is a legislative solution to many of the issues that have heavily tarnished the agency's once gold standard image. The bill is the much awaited "Kennedy-Enzi" bill, also known as The Enhancing Drug Safety and Innovation Act of 2007. Now, the House will take up matters and when passed, it will go to the White House later this summer.
But the reform packaged in the bill is only a solution to the extent that a lack of authority was the problem. After all, up until 6 years ago, the agency did fine without these added powers.
That is not to say that the legislation is not needed - it is. In fact, the agency probably needs more authority than given in the context of this bill.
But what looks to be the eventual passage of the bill should not signal that the problems are now addressed. How those reforms are employed matters every bit as much as having them to execute. This should be viewed as a process and not an event - and FDA reform legislation is only the beginning of that process.
Source: EyeOnFDA.com
RELATED READING:
- Loading Up the PDUFA Cart
- Food Safety: FDA Communications During Crisis
___________________
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