Letter to Margaret Hamburg, Commissioner of the Food and Drug Administration - Withdrawal of "Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products" Proposed Rule

Letter

Dr. Margaret A. Hamburg

Commissioner

U.S. Food and Drug Administration

10901 New Hampshire Avenue

Silver Spring, MD 20993

Dear Dr. Hamburg:

We write to thank the Food and Drug Administration (FDA) for extending the public comment period on the "Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products" proposed rule.

Extending this comment period to May 18, 2015, will allow the FDA to hear from a broad array of stakeholders, so it can craft a well-informed rule.

We wish to respectfully reiterate our concern that this rule would have an adverse effect on patient safety. This would be acutely felt by rural Americans who live in areas with limited Internet access. It would also affect patients and health care providers when electronic technologies are unavailable, including during a power outage or in the wake of a natural disaster or terrorist attack. We hope the FDA will agree to withdraw this proposed rule.

As always, we stand ready to work with you to protect patient safety. Please do not hesitate to contact us, or have your staff contact our staff, if there is anything we can do to work with you on this or any similar issue in the future.

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