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U.S. Department of Health and Human Services


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Options For FDA In Risk Management

Table of Contents: Managing the Risks From Medical Product Use: Creating a Risk Management Framework

Previous Section : FDA's overall Risk Management Activities

Parts 2 and 3 of this report present options for strengthening the pre- and postmarketing risk assessment programs. Similarly, there are a range of options to consider for the Agency's other risk management programs. These are presented below.

Options for improving risk confrontation

FDA should consider using risk confrontation more consistently and effectively in its risk management program. As the literature points out, accurately determining the acceptability of any risk requires that the stakeholders be engaged in the process. Although there has been increasing activity in this area, FDA needs to consider expanding its efforts to involve stakeholders in the risk management process. This could be achieved at several levels.

Systemic risk confrontation.

As discussed above, the Agency should consider convening or participating in meetings with all stakeholders to evaluate the current system and ways to improve it.

Product, indication, or class-specific risk confrontation

In addition to the above-described evaluation of the overall risk management system for medical products, the Agency could take a number of actions beyond risk assessment to improve its risk management efforts. For example, engaging stakeholders on the status of specific product, indication, and product class risks could be institutionalized at FDA (i.e., incorporated into the Agency's overall model of programmatic activities). Examples of possible efforts include the following.

  • Hold periodic FDA advisory committee meetings during which the state of the armamentarium for various indications is discussed and commented on by the advisors and the public
  • Bring new risk information about approved products to advisory committees for discussion and public comment on a systematic basis
  • Include reviews of currently available treatments during advisory committee meetings for specific products
  • Develop ways to incorporate the views of patient groups into ongoing risk assessment, as has been done with the AIDS activists and the hemophilia community
  • Expand partnership activities with other Federal agencies that perform health risk assessments (CDC, NIH, HCFA), and communicate on targeted disease/therapy areas, as has been done for breast cancer control and screening, vaccines, and blood and blood components

Options for improving risk interventions

The management of risks associated with using medical products, known as the practice of medicine, has traditionally been left in the hands of health professionals. The medical community historically has been reluctant to consider certain FDA actions that would limit practice decisions. In recent years, however, that community has increasingly accepted FDA decisions to restrict product distribution or mandate safety programs for risky products. In light of concerns about safety, the Agency could be assigned a more proactive role in risk management, particularly for medical products deemed to have higher-than-usual risks. Of course, adoption of any of the following options would require discussions with all stakeholders, and some of the options would require legislation or rulemaking to fully implement. Examples of possible actions include the following:

  • Restrictions on distribution and/or use for certain products
  • Mandatory education programs for prescribers and patients for certain products
  • Restriction to certain use or prescriber category
  • Identification of newly approved medical products that pose special risks
  • Mandatory relabeling and/or reapproval of products within specific time period after approval
  • Partnerships with Federal payers or accreditors to encourage appropriate prescribing and monitoring of specific drugs.

Options for improving risk communication

FDA carries out extensive risk communication activities. However, these are not carried out in the context of an overall, systematic risk communication strategy. FDA could expand efforts to provide the primary risk managers and consumers with the right information, at the right time, in the right form. This means FDA would need the infrastructure to identify the important risks, target information to those who need it, and make sure it is available in a usable form. It also means that the effectiveness of these strategies would have to be continuously monitored.

FDA could consider developing a comprehensive risk communication strategy for medical products, including (1) categorizing the types and severity of risks and (2) tailoring communication activities based on the category of risk. For example, a risk identified as a serious drug interaction with a common nonprescription medication could trigger an Agency communication primarily to the general public, instead of the healthcare professional. To accomplish these goals, the Agency could use modern communications science to target appropriate audiences, shape messages, and choose communication avenues. FDA could use a variety of communication tools, such as the following :

1. Government-sponsored databases containing information that health professionals could access, including:

  • Comprehensive information on drug-drug and drug-food interactions
  • Registry information on the outcomes of the use of drugs during pregnancy

2. An expanded FDA website, to include:

  • Most recent package inserts
  • Product information sheets, data, and new product information
  • Consumer information including the most commonly prescribed medical products for specific conditions and new approvals
  • Possible links to other sites (e.g., new HHS National Guideline Clearinghouse)

3. Revised package insert format (this effort is in progress) with:

  • Health provider information that is easier to read, and includes more information about the risks and benefits in the Patient Information section
  • Expanded patient-specific information and brief summary in lay language

4. FDA summary of drug approval information that would:

  • Describe remaining areas of uncertainty (e.g., long-term use or patients not studied)
  • Describe safety concerns, including different patient populations (pregnant women, pediatrics, elderly)

5. Template for Dear Healthcare Professional letters (FDA-wide or as appropriate for each center) to make the process of risk communication more consistent that would:

  • Provide a standard document to communicate important risk information in a clear manner
  • Provide guidance on whether a Dear Healthcare Professional letter is needed, or whether another available communication mechanism (e.g., monthly labeling change summary, revitalized FDA Medical Bulletin) can be used
  • Formalize time frames for requiring document to be developed and disseminated

6. Internal guidance to assess when Medication Guides need to be generated

7. Expansion of current partnerships with organizations, including:

  • Other Federal agencies (e.g., CDC, AHCPR, NIH, HCFA)
  • Healthcare organizations and agencies

    --Initiate clearinghouses for disease areas

  • Consumers and patient organizations

    --Establish relationships with health-related patient groups (American Association of Retired Persons, Arthritis Foundation)

  • Prescribers

8. Expansion of current efforts to educate public (outreach), including:

  • Develop PHS campaign on risk understanding

    --Publish articles about assessing risks from medical products in consumer magazines (e.g., Readers' Digest, Consumer Reports)

    --Run public health messages on TV about drugs and risks

    --Partner with other public health agencies (to combine resources)

  • Increase the circulation of FDA Consumer and improve content to send out targeted risk communication messages
  • Talk to health groups at conferences and meetings

    --Work with public affairs specialists in FDA field offices to reach and educate communities and constituents

9. Improved education of new healthcare professionals

  • Work with medical schools and residency program directors to develop with FDA a teaching module on product development, approval, labeling, and risk communication to patients; have school curriculum incorporate this information
  • Continue to support pharmacy internships and externship programs at FDA
  • Provide training to healthcare professional groups

Options for improving evaluation of risk management

Better tools are needed to evaluate the effectiveness of FDA's risk management efforts. The lack of comprehensive epidemiological data on the scope of injuries from medical products makes outcome evaluation difficult. However, several steps could be taken to better assess the results of risk management activities.

  1. Develop an annual report card for newly approved products. The report card would summarize newly learned risk information about the product and would provide an evaluation of how closely the predicted risks correspond to observed events.
  2. Survey health professionals. FDA could consider conducting surveys of health professionals to determine whether risk information is being effectively communicated. Alternatively, sponsors could be requested to obtain such information.
  3. Survey patients. FDA could consider patient or consumer surveys, possibly in partnership with patient or consumer organizations, to evaluate how well specific risk information is being communicated.




1 Presidential/Congressional Commission on Risk Assessment and Risk Management, Framework for Environmental Health Risk Management -- Final Report, Vol. 1, 1997.

2 Leviton, L.C., C.E. Needleman, and M.A.Shapiro, Confronting Public Health Risks: A Decision Maker's Guide, SAGE Publications, Inc., 1998.

3 A formulary is a list of prescription drugs that a health plan has approved for use by its doctors. Health plans that have formularies develop their own unique lists of approved druga. Health plans may only pay for medications that are on this approved list, unless the doctor goes through the health plan's Prior Authorization Process. Formularies may change at any time.

4 Wood, A.J.J., and R.L. Woosley, "Making Medicines Safer -- The Need for an Independent Drug Safety Board," N Engl J Med., 339:851-1854, 1994.

5 Lowrance, W.W., Of Acceptable Risk: Science and the Determination of Safety, William Kaufmann, Inc., 1976.

6 national Research Council, Improving Risk Communications, national Academy Press, 1989.

7 Leviton, Confonting Public Health Risks.

8 National Research Council, Improving Risk Communication.

9 The Center may do this if the failure of the device would be reasonable likely to have serious adverse health consequences; if the device is intended to be implanted in the human body for more than one year; or if the device is a life-sustaning or life-supporting device used outside a device user facility (section 522(21 U.S.C. 3601) of the FD&C Act); see also Appendix G.A.2.

10 A surrogate endpoint is a laboratory finding or physcal sign that may not in itself be a direct measurement of how a patient feels, functions, or survives, but nevertheless, is considered likely to predict therapeutc benefit. For a drug to be approved (given full marketing status) before trails that directly measure clinical outcomes are complete, there must be an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.

11Ostrove, N.M., and L.A. Morris, "Use and Preceptions of Drug Product labeling; A Survey of Physicians," unpublished manuscript, U.S. Food and Drug Administration.

12 This final regulation published December 1, 1998 (62 FR 66378), and will become effective on June 1, 1999.

13Burkhart, G.A., M.J. Sevka, R. Temple, and P. Honig, "Temporal Decline in Filling Prescription for Terfenadine Closely in Time With Those for Either Ketoconazole or Erythromycin," Clin Pham and Ther., 61:93-96, 1997. See also Cavuto, N.J., R.L. Woosley, and M. Sale, Pharmacies and Prevention of Potentially Fatal Drug Interactions," JAMA, 275:1086, 1996.

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