PhRMA attacks New Mexico’s ‘short on detail’ plan for Canadian drug imports
Industry group PhRMA continues to fight a Trump-era final rule to allow drug imports from Canada as the lobbying group has now petitioned the FDA to reject New Mexico’s import plan because of missing details that may make the imported drugs unsafe and not cost-effective.
The application “provides scant indication that the proposed SIP [Section 804 Importation Program] will lead to any—let alone significant—reduction in cost to consumers,” PhRMA said in its petition.
The industry lobbying group called on the FDA to reject the application, noting that it’s incomplete because it fails to identify a foreign seller, importer, or FDA-registered repackager or relabeler for the drugs to be imported, and it provides only a tentative list of drugs.
“New Mexico submitted a proposal so short on detail that FDA cannot assess whether the safety or cost criteria can be met,” PhRMA said.
The lobbying group in January also sought to block Florida’s drug import plan via an FDA petition, claiming it would “jeopardize patient safety.” And the group has filed a lawsuit to stop the final rule, explaining that it could expose patients to risks associated with unapproved, misbranded, and adulterated drugs.
“The Biden Administration has until the end of the month to respond to PhRMA’s complaint,” Rachel Sachs, professor of law at Washington University School of Law, explained to Endpoints News. “But the rule hasn’t been enjoined – no court order is stopping the FDA from approving any submitted plans. However, the plans themselves may not be sufficient to merit approval. PhRMA’s comment on New Mexico’s plan notes that the state has not identified a Foreign Seller – but the final rule explicitly permitted states to submit proposals without doing so, giving them six additional months to identify a Foreign Seller, after which the FDA could deny the proposal.”
Even with a foreign seller, PhRMA also raises concerns about New Mexico’s ability to ensure its plan saves money for consumers, noting that the application offers “only the roughest back-of-the-envelope math (based largely on spending by health plans, not individual consumers) to support its claims that importation would reduce the cost of covered products to New Mexico consumers.” For instance, the plan “ignores substantial start-up and administrative costs which will limit the State’s cost savings or eliminate any savings entirely,” PhRMA says.
The application also offers only a preliminary list of 40 drugs, including 7 to treat HIV/AIDS, and says that the state will conduct two more rounds of re-assessments of drugs to understand whether operational considerations weigh against any of the imports.
“FDA cannot assess whether the safety or cost criteria can plausibly be met without knowing the identity of pivotal supply chain participants or the drugs to be imported,” PhRMA explains.
The group also notes that the 7 HIV/AIDS drugs on the initial list must be stored at a temperature that does not exceed 30 degrees Centigrade. But New Mexico’s application provides “no guidelines for ensuring that each supply chain participant complies with the storage instructions included in each drug’s labeling.”
New Mexico’s application concludes that consumers would save about $9.8 million per year (or $6 million if the HIV/AIDS drugs are excluded) because of the imports. But PhRMA notes that payers and pharmacy benefit managers “are not obligated to reduce premiums or copayments in response to importation, and thus there is no guarantee that consumers will see any savings at all.”
And PhRMA is not alone in its push to halt any drug imports from Canada before the shipments start. Beginning late last November, Canada announced that certain drugs intended for its market are now prohibited from being distributed for consumption outside of Canada if that sale would cause or worsen a drug shortage.