The Future of Drug Safety Promoting and Protecting the Health of the Public (2007) / Chapter Skim
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5 Regulatory Authorities for Drug Safety
5 Regulatory Authorities for Drug Safety
Pages 151-176
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From page 151... ...
The social and health care environment has changed and continues to evolve -- health care providers and patients expect timely access to effective drugs, the user-fee program established in 1992 has increased the pace of drug review and approval, the practice of medicine and the use of drugs have changed, and the information available to the public from advertising and the Internet and from commercial and government or nonprofit sources has transformed consumer knowledge and the patient's role in health care (see Chapter 1 for more information)
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From page 152... ...
. The early 1960s also marked the crystallization of clinical trials into the sequence of phase 1, 2, 3 trials still in use today and described in greater detail in Chapter 2 (DHEW, 1963)
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From page 153... ...
AN AGING AND INADEQUATE STATUTORY FRAMEWORK The statutory authority for drug regulation was constructed decades ago, and it remains largely unchanged. The existing regulatory framework is structured around the premarketing testing process; few tools are available for addressing postmarketing safety issues, short of the blunt instruments to respond to clear-cut adulteration and misbranding.
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From page 154... ...
And in general, such conditions are even more difficult to put in place after the drug has been approved for marketing, as efforts to impose such conditions nearly always depend upon voluntary compliance by the manufacturer rather than on the threat of withdrawal of the drug from the market as an imminent health hazard. The Prescription Drug User Fee Act of 1992 (PDUFA)
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From page 155... ...
PDUFA has clearly expedited agency decision making and has probably led to efficiencies in distinguishing important from less important issues in the final stages of the review process. However, there is concern that the rapid pace of the process needed to meet PDUFA goals (see Chapters 2 and 3)
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From page 156... ...
of New Drug Applications (NDAs) and abbreviated NDA-related postmarketing commitments are "pending" (they are neither "ongoing" nor "delayed")
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From page 157... ...
. 2Medication Guides, or MedGuides, are patient-specific labeling for prescription drug products determined by FDA to have "serious and significant public health concern requiring distribution of FDA-approved patient information" (21 CFR 208.1, 4-1-05 Edition, p.
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From page 158... ...
A 2002 report from the Government Accountability Office concluded that DTC advertising appears to increase spending on prescription drugs and drug utilization (GAO, 2002a)
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From page 159... ...
. FDA's authority to regulate prescription drug advertisements is found in Section 502(n)
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From page 160... ...
. Current statutes give FDA and FTC overlapping and concurrent authority over the labeling of FDA regulated products and over advertising of prescription drugs and devices.
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From page 161... ...
that "current regulations governing prescription drug advertising provide sufficient safeguards to protect consumers." The notice also stated that DTC advertising must meet the same requirements as advertising to physicians, including the "brief summary" of risk information required by statute (21 CFR 202.1)
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From page 162... ...
. The study also found that consumers believe advertisements are more effective in communicating benefits than risks of prescription drugs.
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From page 163... ...
The principles also urged companies to cooperate with FDA to alter or remove DTC advertising when safety issues about an advertised prescription drug arise. Twenty-three drug companies agreed to the new guidelines, and at least two, Bristol-Meyers Squibb and Pfizer, announced moratoria (for 1 year, and 6 months, respectively)
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From page 164... ...
The committee learned in conversations with and from literature about several former FDA leaders that even in cases where authority was not clear-cut, the
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From page 165... ...
The committee asserts that the bully pulpit route leaves potentially critical regulatory action vulnerable to a subjective and highly variable process of exercising individual or agency influence, and to the vicissitudes of changing attitudes toward regulation. That is why FDA's authorities must be clarified and strengthened to empower the agency to take rapid and decisive actions when necessary and appropriate.
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From page 166... ...
For others, the review of postapproval data will give FDA an opportunity to reconsider the drug's risk-benefit profile and respond to safety issues. Over the years, patient groups and industry representatives have expressed concern that regulatory actions that are too risk-averse could stifle innovation in drug development.
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From page 167... ...
For most drugs, the existing interaction between regulator and sponsor is adequate -- incoming safety information does not reveal extremely serious unlabeled adverse events (AEs) , and regulatory re-examination (for new indications and labeling changes)
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From page 168... ...
The sponsor later withdrew natalizumab from the market and began working with CDER staff to develop a risk management program (including restricted distribution through certified infusion centers and so on)
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From page 169... ...
f. Distribution conditioned on the performance of specified ad ditional clinical trials or other studies.
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From page 170... ...
. A Symbol to Denote Limited Knowledge About New Drugs A recurring theme in this report is the committee's concern that the public and even health care providers may base their choices and behaviors related to prescription drugs on inaccurate assumptions.
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From page 171... ...
The symbol should remain on the drug label and related materials for 2 years unless FDA chooses to shorten or extend the period on a case-bycase basis. The committee believes that companies should refrain from DTC advertising during the black triangle period, and would favor imposition of a formal moratorium on such advertising.
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From page 172... ...
The committee finds that a lifecycle approach to risk and benefit would be facilitated by establishing a milestone in a drug's lifecycle for a comprehensive review of consolidated safety and efficacy data and the status of postmarketing conditions and commitments (see Chapter 4 for discussion of the assessment of risks and benefits)
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From page 173... ...
4Product safety specialists from the Center for Biologics Evaluation and Research routinely develop reviews of the postmarket safety experience with a new vaccine within 2–3 years of the time the vaccine is licensed. These reviews are published in journals and are available on the FDA Web site's Vaccine Adverse Event System page.
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From page 174... ...
2005. Patient and Physician Attitudes and Behaiors Associ ated with DTC Promotion of Prescription Drugs -- Summary of FDA Surey Research Results.
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From page 175... ...
2002b. Food and Drug Administration: Effect of User Fees on Drug Approal Times, Withdrawals, and Other Agency Actiities.
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From page 176... ...
2000. Direct-to-consumer prescription drug advertising: trends, impact, and implications.
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