CBP Warns About Improper Filing of Prescription Drug Prices Amid Coordinated Effort to Steer Prices
In the wake of President Donald Trump's May 12 executive order on prescription drug prices, CBP warned that it would "pursue any violations to the fullest extent possible" if it discovers that a party is failing to correctly input values related to prescription drug prices.
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In a May 21 release, CBP informed the trade community to refer to and review the Department of Health and Human Services' price targets for prescription drugs, noting that "declaring incorrect value on import or export documentation submitted to CBP is considered trade evasion." Violations can be reported through the e-Allegations Online Trade Violation Reporting System, it said.
CBP's announcement follows those from other federal agencies also claiming to address Trump's executive order calling for lower prescription drug prices.
HHS announced that the price targets mentioned in CBP's statement are available for pharmaceutical manufacturers, who "are expected to meet to satisfy the requirements of the Executive Order," according to a May 20 release.
According to the HHS release, each pharmaceutical manufacturer is expected "to commit to aligning U.S. pricing for all brand products across all markets that do not currently have generic or biosimilar competition with the lowest price of a set of economic peer countries. The [most favored nation (MFN)] target price is the lowest price in an [Organization for Economic Cooperation and Development (OECD)] country with a GDP per capita of at least 60 percent of the U.S. GDP per capita."
HHS said the targets will bring down U.S. drug prices while preserving innovation.
A third announcement, from the FDA, said that the agency plans to offer pre-submission reviews of states' draft proposals for Section 804 importation programs (SIP) under the Federal Food, Drug and Cosmetic Act. That review could help states and Indian tribes import certain prescription drugs from Canada, FDA said.
States would submit a draft proposal that the FDA would then review and provide initial feedback before the states formally submit their proposal for an SIP
The FDA says the preliminary review could clarify requirements, enhance the quality of submitted proposals and shorten the review time.
In addition to the review, the FDA says it will develop a tool to help assist states in developing their proposals, and it is working with states to streamline the required cost savings analysis.
The FDA plans to meet with interested states in the fall to gather feedback on the program.