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1 Introduction
Pages 15-30

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From page 15...
... (conflict of interest in its advisory committees) and about the possibility of undue industry influence related to CDER's increasing dependence on Prescription Drug User Fee Act (PDUFA)
From page 16...
... However, criticism of the pace of drug approval may be traced to the early 1970s. At that time, pharmaceutical companies, scientists, and consumer organizations argued that the 1962 Drug Amendments to the Food, Drug, and Cosmetic Act, intended to strengthen the drug approval process by requiring that sponsors demonstrate efficacy, also stifled drug development and delayed drug approval (DHEW, 1977)
From page 17...
... The Committee on the Assessment of the US Drug Safety System believes that as more drugs are being approved faster with less time to intensively investigate premarketing safety data, FDA does not have adequate resources or procedures for translating preapproval safety signals into effective postmarketing studies, for monitoring and ascertaining the safety of new marketed drugs, for responding promptly to the safety problems that are discovered after marketing approval, and for quickly and effectively communicating appropriate risk information to the public. The committee is aware of promising components of the current drug safety efforts at CDER and of agency improvement initiatives (see Appendix A)
From page 18...
... The behavior of prescribers, the gatekeepers for patient access to prescription drugs, are also under public and congressional scrutiny, as health care providers receive intense and targeted promotional ("detailing") efforts of pharmaceutical companies.
From page 19...
... Those are but some of the factors that make this a moment of opportunity to renew and transform CDER, to enable it to function more effectively and to position itself for a far more complex future. Changes in the Broad Context of Drug Regulation Prescription drug development, regulation, and use have changed greatly since the 1962 drug amendments and continue to evolve.
From page 20...
... , FDA asserted that the translation from the basic sciences of drug discovery to the applied sciences of drug development has become sluggish because "the development path is becoming increasingly challenging, inefficient, and costly." The practice of medicine and the provider-patient interaction -- the point where the pharmaceutical product traditionally "meets" the patient -- also have undergone great transformation in the last two or three decades. First, use of prescription drugs has been increasing steadily (Ganslaw, 2005)
From page 21...
... . Defining and Meeting the Charge The Charge Given the changes outlined above and in response to growing public concern with health risks posed by prescription drugs, FDA requested that the Institute of Medicine (IOM)
From page 22...
... Other consumer and patient advocacy groups began to call for changing the drug approval process to speed up the availability of potentially life-saving or life-sustaining drugs to patients in need of them. Consumer groups, regulators, the regulated industry, and others contributed to and Congress passed the PDUFA legislation that aimed to ensure that FDA had adequate resources to expand its drug review staff and capabilities, and so to increase the pace of drug reviews.
From page 23...
... No PDUFA funds were allocated to postmarketing drug safety activities until 2002, when limited funds were allocated for limited safety activities. The 1992 PDUFA Amendments to the FD&C Act stipulated that PDUFA user fees must not be used in lieu of but to supplement appropriations.
From page 24...
... in ensuring drug safety as part of the US health care delivery system; • examine the current efforts for the ongoing safety evaluation of marketed drug products at the FDA and by the pharmaceutical industry, the medical community, and public health authorities; • evaluate the analytical and methodological tools employed by FDA to identify and manage drug safety problems and make recommendations for enhancement; • evaluate FDA's internal organizational structure and operations around drug safety (including continuing postmarket assessment of risk vs. benefit)
From page 25...
... drugs or the switch from prescription to OTC status; generic drugs; drug pricing; or the causes and consequences of the current challenges in pharmaceutical innovation. Finally, although the postapproval stage of a drug's life cannot be discussed in isolation from the preapproval stages, this report does not consider in any detail the complex ethical, practical, economic, and scientific issues related to the Investigational New Drug process or the clinical trial conduct in the testing of drugs.
From page 26...
... 3A list of materials reviewed by the committee (in the form in which they were reviewed) , including all submissions of information from the public and many items not cited in this report, can be found in the study's public access file, obtained from the National Academies Public Access Records Office at (202)
From page 27...
... In a strengthened drug safety system, that juncture should mark the beginning of another important stage in the lifecycle, when regulators, sponsors, health insurers, health care providers, and independent researchers actively pursue and manage emerging knowledge about risk-benefit relationships and uncertainty and they communicate that knowledge to patients, and health care organizations in a timely manner. Regulatory, health insurance coverage, and treatment decisions over a drug's lifecycle depend on the quality and timeliness of data collected, evaluated, and transmitted by trustworthy stakeholders in the health care system.
From page 28...
... For the health care delivery system, a lifecycle approach to risk and benefit implies the need to heed and follow FDA communication about drug safety matters and to exercise appropriate caution in drug-related decision making (from formularies to prescribing) in recognition of the limited information available at the time of drug approval.
From page 29...
... 2002. Reauthorization of the Prescription Drug User Fee Act.
From page 30...
... 2005. The Prescription Drug User Fee Act: is a faster Food and Drug Administration always a better Food and Drug Administration?


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