WASHINGTON, D.C. – Yesterday, U.S. Senators Susan Collins and Angus King and Congressman Bruce Poliquin sent a letter to United States Food and Drug Administration (FDA) Commissioner, Dr. Margaret A. Hamburg, urging FDA to withdraw the “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products” proposed rule.

The proposed rule by the FDA would allow pharmaceutical companies to substitute electronic prescription information for the paper inserts that are currently available to physicians, pharmacists and other health care professionals. This proposed rule would have a negative impact not only on the health care providers who utilize the written information, but also on rural families, and particularly seniors, who have limited Internet access in Maine.

“Pharmaceutical paper inserts are an important tool for our pharmacists and health care professionals that are in charge of administering life-saving medications to our hardworking families and seniors,” Senators Collins and King and Congressman Poliquin said in a joint statement. “While we are pleased the public comment period has been extended, we will continue to press FDA to reconsider and withdraw this harmful proposed rule.”

The following is the full text of the letter:

March 23, 2015

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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