Food and Drug Administration Reinvention Goal:

Better Medical Product Information

Initial Goal Statement (December, 1997):

Current Goal Statement:

Forecast Completion Date:

Status:

The Agency has made pivotal progress toward improving the labeling information on OTC drugs. On March 11, 1999, FDA announced a final FDA regulation to provide new, easy-to-understand labeling on nonprescription drugs.

The regulation calls for a standardized format that will improve the labeling on drugs Americans use most--nonprescription, or over-the-counter (OTC) drugs. By clearly showing a drug's ingredients, dose and warnings, the new labeling will make it easier for consumers to understand information about a drug's benefits and risks and about the proper use of the drug.

FDA proposed its OTC labeling regulation in February 1997. It developed the new label format based on almost 2,000 comments from the proposed regulation and through several years of Agency work with consumer and industry groups. The rule has been developed so that all OTC drugs have labeling that is easy to read and understand. The new labeling will also provide consumers with better information for selecting the most appropriate OTC medication and understanding its benefits and risks.

Titled "Drug Facts," the new labeling makes it easier for consumers to identify active ingredients, which will be listed at the top, followed by uses, warnings, directions and inactive ingredients. FDA recommends that drug manufacturers include a phone number for consumers to call for more information or for answers to their questions. The requirement for listing inactive ingredients will allow consumers to select products that do not contain ingredients to which they are allergic. The rule also sets minimum type sizes and other graphic features for the standardized format, including options for modifying the format for various package sizes and shapes.

FDA has developed a public education campaign to help consumers understand how the new labels can be used to learn more about OTC medications. This educational campaign will include print and radio public service announcements, consumer brochures, point-of-purchase posters and other exhibit materials. FDA will also work in partnership with national health and professional organizations such as the Nonprescription Drug Manufacturers Association to disseminate this information across a wide range of education networks.

In many cases, OTC drugs with the new labeling will begin appearing on the shelves within the next two years. All OTC drugs will be required to adopt the new labeling within the next six years.

Prescription Drug Labeling

FDA's role in this initiative, as mandated by Congress,* is to monitor industry's progress and confirm that consumer information on prescription drugs is widespread and useful by the year 2000. The American public has been the beneficiary of long-range efforts by the pharmaceutical industry and FDA to meet this goal. An FDA study showed that in 1996, 67 percent of patients received written information that was longer than a brief sticker with their prescription. This is a significant improvement from 54 percent in 1994 and a major step toward meeting the year 2000 target. As consumers receive more material, the Agency is implementing its second responsibility, to evaluate the information's usefulness. The FDA began conducting these studies in 1998.

The Agency is developing a proposed rule for prescription drug labeling and various labeling guidance documents. The common goal of the rule and guidance documents is to make prescription drug labeling easier to access, read and use (this labeling is oriented toward health care professionals).

Another accomplishment highlights FDA's focus on women's health needs. The Agency, as part of its effort to improve the usefulness of the pregnancy section of the label, held public and advisory committee meetings to inform consumers and health care professionals about progress on this issue.

The related performance measures include:

1. Conduct a National Telephone Survey for 1998.

   Status: Survey completed; findings now available.

2. Conduct a National Telephone Survey for 2000.

   Status: CDER has been unable to obtain OMB clearance for the year 2000 repeat of the survey. OMB is requiring an 80% response rate, which is extremely difficult to obtain with the anticipated funding level. CDER is working with the Center for Food Safety and Applied Nutrition as well as the Office of Policy to deal with this issue. In addition, funding is still needed for this survey, although we have been assured that a marker has been put into ASPE's funding plans for it. It remains to be seen whether priorities at that time will permit funding.

3. Conduct a Quality Review Study Baseline.

   Status: CDER has a contract with the National Association of Boards of Pharmacy (NABP) to conduct this study (funded by ASPE). Together with its University of Wisconsin subcontractor, NABP is in the process of refining the Keystone evaluation standards criteria for the 3 drugs for which materials will be collected. The materials collection protocol is currently being piloted and data collection is complete. We anticipate results of the study being publicly available in fall 1999.
   

4. To conduct a Quality Review Follow-up Study.

   Status: Funding is needed -- see #2 above regarding ASPE markers. Design, etc. will be partly dependent on public responses to the baseline study methodology.

    

5. To conduct a Risk/Benefit Communication study of gender differences in risk communication.

   Status: The study was completed and findings provided to the FDA's Office of Women's Health. Publication of results in a peer-reviewed journal is anticipated in early 2000.

*Agriculture, Rural Development, Food & Drug Administration & Related Agencies Appropriations Act (PL 104-180)

Location in FY 1999 Strategic Plan:

Location in FY 1999 Performance Plan:

1. Assure the availability, quality and usefulness of prescription drug information provided to 75 percent of individuals receiving new prescriptions: and complete two studies to develop comprehensive drug information.
2. Continue to improve the legibility and clarity of OTC drug labels, improve the consumer's ability to understand warnings and usage directions.

Location in FY 2000 Performance Plan:

1. Make new drug approval information increasingly available and targeted and promoted to specific user groups, such as consumers, patients, health-care practitioners and industry via the internet, resulting in a decrease in serious medication errors. (Page 61)
2. Develop partnerships with eight national organizations to disseminate educational information to consumers about choosing the right medications, taking medications correctly and reporting adverse reactions. (Page 62)