Critical Point Three: Prescription Drug User Fee Act
With the FDA budget still unadjusted for inflation and slashed from Reagan’s Regulatory Relief program, the agency was severely understaffed and under-resourced. Though the parallel track and treatment IND programs decreased the trial periods and drug lag for drugs helping “life-threatening conditions,” the average drug review period was still over a year. FDA management was struggling to decrease review times across the board with the added pressure of severe cuts to its budget, set by Congress. During the same time when staffers were decreased from 8,200 to 7000, Congress delegated new responsibilities in food and drug regulation to the agency. Staffers were either being let go to cut costs of the agency or leaving on their own accord in response to low salaries. Although the Prescription Drug User Fee Act was …show more content…
As explained in Stephen Ceccoli’s Pill Politics: Drugs and the FDA, this formal change in the mission symbolizes the transformation of the agency’s priority to avoid Type II errors with the same diligence as avoiding Type I errors. While Type II errors can go completely unnoticed by the public, the environment in which the FDA was working during this time was hyperaware of such errors, following the AIDS epidemic. Prior to the AIDS epidemic and social activism surrounding it, it was nearly universally agree upon that the FDA was responsible for protecting public health by ensuring the consumers were not exposed to harmful drugs; however, with these regulatory shifts and public health crises, policymakers and reviewers began to acknowledge that public health is also dependent on timely approval and access to safe drugs for the
With the FDA budget still unadjusted for inflation and slashed from Reagan’s Regulatory Relief program, the agency was severely understaffed and under-resourced. Though the parallel track and treatment IND programs decreased the trial periods and drug lag for drugs helping “life-threatening conditions,” the average drug review period was still over a year. FDA management was struggling to decrease review times across the board with the added pressure of severe cuts to its budget, set by Congress. During the same time when staffers were decreased from 8,200 to 7000, Congress delegated new responsibilities in food and drug regulation to the agency. Staffers were either being let go to cut costs of the agency or leaving on their own accord in response to low salaries. Although the Prescription Drug User Fee Act was …show more content…
As explained in Stephen Ceccoli’s Pill Politics: Drugs and the FDA, this formal change in the mission symbolizes the transformation of the agency’s priority to avoid Type II errors with the same diligence as avoiding Type I errors. While Type II errors can go completely unnoticed by the public, the environment in which the FDA was working during this time was hyperaware of such errors, following the AIDS epidemic. Prior to the AIDS epidemic and social activism surrounding it, it was nearly universally agree upon that the FDA was responsible for protecting public health by ensuring the consumers were not exposed to harmful drugs; however, with these regulatory shifts and public health crises, policymakers and reviewers began to acknowledge that public health is also dependent on timely approval and access to safe drugs for the