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ASHP Letter of Support for S. 3519

Senators Hatch and Bennet

November 5, 2018
The Honorable Orrin G. Hatch
United States Senate
104 Hart Senate Office Building
Washington, DC 20510
The Honorable Michael Bennet
United States Senate
261 Russell Senate Building
Washington, DC 20510

Dear Senator Hatch and Senator Bennet:

ASHP (American Society of Health-System Pharmacists) is fully supportive of S. 3519, the “Making Objective Drug Evidence Revisions for New Labeling Act” or the “MODERN Labeling Act.” ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s 45,000 members include pharmacists, student pharmacists, and pharmacy technicians. For more than 75 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety.

ASHP has a longstanding record in evidence-based evaluation of information on drug use. Since 1959, the AHFS Drug Information (AHFS DI) published by ASHP is recognized as the most comprehensive source of unbiased and authoritative drug information available to health professionals today. AHFS DI staff includes drug information pharmacists and other professional editorial and analytical experts who thoroughly research AHFS DI content. Authors incorporate clinical research findings, therapeutic guidelines, and Food and Drug Administration (FDA) approved labeling to ensure that monographs include an evidence-based foundation for safe and effective drug therapy.

The U.S. Congress and various healthcare insurance providers have also recognized the authority of the AHFS DI information on the medically accepted uses of drugs. AHFS DI has been listed by the American College of Physicians-American Society of Internal Medicine as a standard item for inclusion in reference libraries and has been a required drug reference for pharmacies in most states. The compendium is independent from the influence of pharmaceutical manufacturers, health insurers, pharmacy benefit managers, and other third parties.

S. 3519 would apply the same evidence standards that FDA currently applies in its review of NDAs and ANDAs for labeled uses. The rationale behind the legislation is to provide an opportunity for additional evidence-based uses to make their way into labeling after all patents and exclusivity have elapsed, i.e., when the drug is available only generically. At that point, there is little incentive for a generic manufacturer to pursue formal approval through the ANDA process due to cost. The process outlined in the bill would rely on already published data to support its approval under the new mechanism. The process also would allow for review and removal of obsolete information such as uses for which a drug no longer would be considered optimal therapy. The ultimate beneficiary would be the patient.

As we have worked with Congress in the past on a number of important public health issues, including drug shortages and compounding, ASHP welcomes the opportunity to be a resource for your office on the MODERN Labeling Act. Again, we thank you for your leadership on this crucial program and look forward to working with you as you advance the bill.

Please contact me with any questions, or have a member of your team contact Christopher Topoleski, Director of Federal Legislative Affairs, at 301-664-8806 or at [email protected].

Kasey K. Thompson, Pharm.D., M.S., M.B.A.
Chief Operating Officer and Senior Vice President