Records: Drug distributors push back on proposed Ohio rules

The Food and Drug Administration is planning new rules for drug wholesalers later this summer

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COLUMBUS (AP) — Companies that distribute drugs are pushing back on stricter regulation in Ohio, protesting what they call a patchwork approach that could lead to confusion and uncertainty, records show.

The state pharmacy board should wait for new federal regulations before enacting state rules, including some that could violate federal law, the companies say in documents obtained by The Associated Press through a records request.

“A ‘patchwork’ system of differing regulations between and among states and the federal government will only lead to more problems,” Gary Cacciatore, vice president of regulatory affairs for Ohio-based Cardinal Health, said in a Feb. 23 letter to the board.

The Food and Drug Administration is planning new rules for drug wholesalers later this summer, while the Drug Enforcement Administration is working on its own regulation for dealing with suspicious drug orders.

Better to wait for those proposals than enact state-specific rules now, said Patrick Kelly, government affairs vice president for Healthcare Distribution Alliance.

For companies, “Undertaking such activities repeatedly, and over a short period, could create confusion and inconsistency, potentially undermining the very security that the federal and state requirements aim to enhance and maintain,” Kelly told the pharmacy board.

The Independent Pharmacy Cooperative took issue with several aspects of Ohio’s proposed regulations for handling suspicious orders, including a requirement that companies submit paperwork when no suspicious orders are detected.

Such paperwork “places an undue and onerous burden on dangerous drug distributors,” said John Convello, the IPC government relations director.

Grocery store chain Kroger, drugmaker Pfizer and drug distributor AmerisourceBergen were among other companies raising similar objections, according to the records reviewed by the AP.

Republican Gov. John Kasich announced the proposals on Feb. 1 as part of efforts to slow the opioid epidemic that kills more than 11 Ohioans a day.

Among the requirements: wholesalers that distribute prescription drugs to pharmacies, doctors and hospitals would have to report more information about suspicious orders to Ohio regulators.

The state also wants drug distributors to do a better job researching their customers and to hold onto suspicious orders until questions are answered about the drugs’ destination.

Companies that do not comply could have their drug distribution license for Ohio revoked. Red flags could be large orders of controlled substances like pain pills or cash-only orders.

Companies will have at least three more opportunities for input as the rules make their way through Ohio’s regulatory process, said Cameron McNamee, the pharmacy board’s communications and policy director.

The board is aware of the companies’ concerns and will weigh them carefully, he said. But McNamee also notes federal action could take years.

“If we always took a wait-and-see approach to what happened at the federal level, we probably wouldn’t get anything done,” McNamee said.

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