Upton Leads Bipartisan, Bicameral Effort Seeking Prompt Release of Proposed Electronic Labeling Rule

February 7, 2014

Leaders Seek Release to Boost Patient Safety and Transparency

WASHINGTON, DC – Bipartisan leaders of the House Energy and Commerce Committee and Senate Committee on Health, Education, Labor, and Pensions today sent a letter to Office of Management and Budget Director Sylvia Burwell requesting prompt release of the proposed rule for electronic drug labeling, which is currently under review.

In the letter to Burwell, the bicameral leaders write, “As the pharmaceutical market has evolved, electronic data interchange has become more common for commercial and regulatory interactions. For example, the Food and Drug Administration (FDA) has required manufacturers to submit drug labeling information in an electronic format since 2005. Additionally, electronic labeling has been cited by the FDA as allowing for the efficient distribution of updated information to health care providers about a prescription drug. Consequently, the agency has repeatedly included electronic labeling in its semi-annual regulatory agenda. However, FDA’s specific plans regarding electronic labeling have yet to be made public.”

The letter was signed by House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Ranking Member Henry A. Waxman (D-CA) and Senate Committee on Health, Education, Labor, and Pensions Chairman Tom Harkin (D-IA) and Ranking Member Lamar Alexander (R-TN).

Chairman Upton commented, “Electronic labeling is an important step in protecting local communities, ensuring patients have access to the most affordable drugs, and providing the most updated safety information. It is important that stakeholders are allowed time for thoughtful review and we hope that OMB will help in that effort by releasing this important rule.” 

A copy of the signed letter is available HERE.