One of the primary responsibilities of the FDA is the approval of pharmaceutical drugs based on criteria of safety and effectiveness. This control has developed over the past century in response to tragedies that resulted from the lack of rigorous drug testing prior to a drug’s circulation. In this way, the FDA acts as a safeguard against companies peddling ineffective, unsafe, or simply untested products for the sake of profit.2 The current drug approval system works by implementing a series of regulated studies which act as safeguards. However, it is important to note the the FDA itself does not conduct these studies.1 Pharmaceutical companies that develop new drugs must seek FDA approval by conducting tests and reporting the results. The
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Since the FDA has a very public image that is highly liable to accusations of blame if adverse effects occur from a drug that they approved.2 The media and the public would not be forgiving of lapses in the approval process that contributed to the approval of a bad drug. Thus, the media and the public hold the FDA highly accountable. With this in mind, the FDA is highly conscious that failing to approve an effective drug is less blameworthy than approving a faulty drug.2 Yet, ironically, it is this very conservatism that informs many of the complaints about FDA regulation. One of the criticisms of the drug approval system is that it is overly rigorous. The FDA has very rigorous standards that can be challenging to meet. For example, in 2003 a FDA advisory committee declined to endorse the use of aspirin in preventing a first heart attack although it has been approved to prevent second heart attacks.2 This is because the FDA requires drugs to prove their effectiveness “beyond a reasonable doubt.” This is a very high benchmark.2, 3 Many might argue that this benchmark is too high and that the FDA should allow more leeway in measures of …show more content…
By narrowly defining the scope of what is “effective”, drugs may be approved based on their efficacy in one area without noting their effect in the larger picture.3 For example, drugs may be approved if they are able to lower blood pressure, but this does not say anything about it’s ability to improve life expectancy.3 Additionally, while drugs are required to be effective, they are not required to be more effective than drugs currently on the market. Finally, there is some doubt about the scope of individuals that rigorous testing can reach. It can be difficult to test drugs on certain groups of people for ethical reasons (such as groups of pregnant women).2,3 Therefore, many argue that the FDA’s measures of effectiveness are imperfect and inconsistent. In this way, the FDA creates a very rigorous system that while important for safety standards, can in some cases be misleading when it comes to
Since the FDA has a very public image that is highly liable to accusations of blame if adverse effects occur from a drug that they approved.2 The media and the public would not be forgiving of lapses in the approval process that contributed to the approval of a bad drug. Thus, the media and the public hold the FDA highly accountable. With this in mind, the FDA is highly conscious that failing to approve an effective drug is less blameworthy than approving a faulty drug.2 Yet, ironically, it is this very conservatism that informs many of the complaints about FDA regulation. One of the criticisms of the drug approval system is that it is overly rigorous. The FDA has very rigorous standards that can be challenging to meet. For example, in 2003 a FDA advisory committee declined to endorse the use of aspirin in preventing a first heart attack although it has been approved to prevent second heart attacks.2 This is because the FDA requires drugs to prove their effectiveness “beyond a reasonable doubt.” This is a very high benchmark.2, 3 Many might argue that this benchmark is too high and that the FDA should allow more leeway in measures of …show more content…
By narrowly defining the scope of what is “effective”, drugs may be approved based on their efficacy in one area without noting their effect in the larger picture.3 For example, drugs may be approved if they are able to lower blood pressure, but this does not say anything about it’s ability to improve life expectancy.3 Additionally, while drugs are required to be effective, they are not required to be more effective than drugs currently on the market. Finally, there is some doubt about the scope of individuals that rigorous testing can reach. It can be difficult to test drugs on certain groups of people for ethical reasons (such as groups of pregnant women).2,3 Therefore, many argue that the FDA’s measures of effectiveness are imperfect and inconsistent. In this way, the FDA creates a very rigorous system that while important for safety standards, can in some cases be misleading when it comes to