170517 drugimportation burgess green

Published

May 17, 2017

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This letter was sent to the members of the House Subcommittee on Health opposing any amendments that may be offered to the Food and Drug Administration Reauthorization Act of 2017 that would allow the importation of foreign pharmaceuticals into the United States or that would undermine the preemptive authority of federal food and drug regulations. The Subcommittee is marking up the bill tomorrow morning.

May 17, 2017

Dear Chairman Burgess and Ranking Member Green:

The U.S. Chamber of Commerce believes it is important to maintain the safety and integrity of America’s drug supply and therefore strongly opposes any amendments that may be offered to the Food and Drug Administration Reauthorization Act of 2017 that would allow the importation of foreign pharmaceuticals into the United States or that would undermine the preemptive authority of federal food and drug regulations.

Changes in law to allow individual importation and distribution of drugs not approved by the Food and Drug Administration (FDA) could put Americans at risk by opening America’s drug supply to unsafe, counterfeit, or sub-standard medicines. The results could range from an increased flow of foreign drugs of unknown origin that differ from U.S. versions, to weakened intellectual property protections in circumvention of existing international standards. Attempts to legalize importation in this way would prevent FDA from ensuring the safety and effectiveness of America’s medications.

The Chamber also opposes any legislation that would reverse Supreme Court precedent that confirmed the preemptive power of federal food and drug regulations. Preemption is an important legal doctrine that ensures uniformity in the application of regulations and prevents state law from encumbering federal regulatory schemes. By undermining preemption in the food and drug arena, such amendments would needlessly expand state tort litigation and adversely impact both the manufacturers of life-saving drugs and the millions of Americans who depend upon affordable pharmaceuticals.

The Chamber strongly opposes any amendments that may be offered to the Food and Drug Administration Reauthorization Act of 2017 that would allow the importation of foreign pharmaceuticals into the United States or that would undermine the preemptive authority of federal food and drug regulations.

170517 drugimportation burgess green