SUMMARY OF CHALLENGES AND OPPORTUNITIES

Jonathan R. Davis, Ph.D., Editor

The changing health care environment has produced more restrictive drug formularies, a development originally intended to help reduce prescription drug costs while still maintaining quality health care. Some data suggest that these goals have not materialized and that formulary policies concerning antibiotics may be contributing to the rise in the rates of antibiotic resistance. The original goals of formularies need to be reevaluated. Although further studies are needed to address the increasing costs associated with formularies, some cost-containment practices may be possible without imposing negative repercussions on the quality of health care. These include greater control of second-opinion requirements, increased rigidity of gatekeepers and case managers, implementation of drug and physician office visit copayment levels, greater use of generic drugs, and greater limitations on formularies.

Ensuring Availability of Current Information on New Drugs

The Forum members wanted to highlight several initiatives that were discussed at the workshop and that could be implemented to adequately address the changing health care environment. As the regulatory agency of the government, FDA ensures that proper drug development information is disseminated to health care practitioners and individuals responsible for health care decision making and that safe and effective drugs are available to the public in the least amount of time. FDA can thus continue to administer several initiatives to try to make sure that there is a positive transition to a new health care environment. Not only can it provide information and expertise useful for the evaluation of drug formularies and drugs benefits programs, but it can also collaborate with other agencies in sponsoring workshops specifically intended to assist managed care organizations and other health care organizations with evaluating the designs of drug benefits programs. In addition, FDA is uniquely positioned to implement health care policies in an effort to efficiently and swiftly disseminate information on new uses of drugs and medical devices, as well as provide guidance on medical product promotion in the managed care environment and guidance on broadcast advertising policies. A continued revision of guidance and policy is likely to sustain the positive effect that FDA has on health care activities in the changing health care environment.

Managing Antibiotic Selective Pressure

Microbial resistance is exacerbated by the use of broad-spectrum antibiotic therapy, a practice often encouraged by drug formularies. The extensive use of



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