PhRMA: Drugmakers’ Reputation at Stake in Fight to Rout Rx Import Law

October 25, 2013

A new law passed by the state of Maine allowing for the importation of prescription drugs via internet pharmacies has the drug industry fretting that its image is about to take another hit. Mainers say it’s all about cost, but PhRMA says patient safety has no price.

The law, which went into effect Oct. 9, reflects a first-of-its-kind breakaway from federal restrictions on drug imports — strictures partially predicated on concerns about counterfeits and substandard drugs entering the U.S. supply chain.

The law allows for the direct purchase of drugs from online pharmacies located in Canada, New Zealand, Australia and the UK. The pharmacies would then distribute drugs, often available at a cheaper cost, to consumers. However, critics of the law say the drugs haven’t been screened by the FDA and verified to be safe and effective.

PhRMA, the Maine Pharmacy Association, various Maine pharmacy and retail groups and independent pharmacies filed suit in September seeking to nullify the law after their entreaties to the FDA and the Drug Enforcement Administration failed to elicit a reaction.

The lawsuit, filed in the U.S. District Court for the District of Maine, contends the state law violates a provision in the 1938 FD&C Act strictly prohibiting importation of foreign drugs unapproved by the FDA.

“The FDA has repeatedly stated that federal law preempts any and all state laws that would facilitate the private importation of foreign pharmaceutical products,” the lawsuit reads.

Requests for comment to the U.S. Attorney’s Office in Maine and Maine’s Attorney General were not returned as of press time. The FDA declined to comment, citing a lack of resources to do so due to the ongoing federal government shutdown.

The pharmaceutical industry, continually contending with injury liability cases, could face more lawsuits as the law takes hold, Mit Spears, PhRMA’s executive vice president and general counsel, suggested in comments.

“It’s our reputation that’s going to be at stake, not CanaRx,” he said, referencing the Canadian internet pharmacy that some municipalities in Maine have already contracted with to provide drugs for their public workers.

The internet pharmacy in 2003 was warned by the FDA about its distribution of drug supplies from “unregulated sources” and potential to expose U.S. consumers to “risky” products. The agency also expressed concern about the pharmacy’s shipping practices.

Maine’s new law would also “blow a hole” in the industry’s efforts to support a nationwide pharmaceutical track-and-trace system, Spears said. “As an industry, we have spent a ton of time, money and energy making sure that products are distributed securely and handled properly,” he added.

Spears called the law “irresponsible” because other states could adopt similar measures. “We need a court to rule this out,” he said.

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