On Tuesday, June 6, 2017, this letter was sent to the members of the House Energy and Commerce Committee opposing any amendments that may be offered to H.R. 2430, the FDA Reauthorization Act (FDARA) 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 Committee will mark up the bill tomorrow morning.
June 6, 2017
Dear Chairman Walden and Ranking Member Pallone:
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 H.R. 2430, the FDA Reauthorization Act (FDARA) 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 the FDA from ensuring the safety and
effectiveness of America’s medications.
According to a report released today, the potential for lower drug prices for a small
percentage of Americans would pale in comparison to the potential costs to the safety of
American consumers and the integrity of the prescription drug supply chain, as well as the
increased burden on U.S. law enforcement that would impact communities across the country.
Additionally, and equally alarming, are predictions that importation proposals would intensify
the country’s current opioid crisis which “has already grown substantially worse due to the
powerful opioid fentanyl and fentanyl analogue-laced counterfeit pills being produced by illegal
drug trafficking organizations, including in China, and reaching the United States through
Canada and Mexico.” Despite common stipulations that controlled substances would be
ineligible for importation, importation would actually increase threats in this area, according to
this report, “due to the masking/mislabeling of illegal opioids, increased profit opportunities, low
penalties faced by criminals, and insufficient law enforcement resources.”
The Chamber strongly opposes any amendments that may be offered to the FDA
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.
Sincerely,
Neil L. Bradley
cc: Members of the Committee on Energy and Commerce
