Pacific Research Institute CEO Begs Florida to Keep Counterfeit Drugs out of The State

Source: Commonwealth Club

This editorial by Sally C. Pipes was published in The Orlando Sentinel on March 20, 2019.  Sally C. Pipes is president, CEO, and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute.

Keep counterfeit drugs out of Florida| Commentary

Florida's House budget panel this week greenlit a bill that would allow the state to buy drugs from Canada. Lawmakers are poised to debate a companion bill in the Senate in the coming weeks. If the bill becomes law, officials would almost certainly need permission from the U.S. Department of Health and Human Services to move forward. And to receive that permission, they'd need to prove that drug importation would be both safe and economical.

It's neither.

The bill — HB 19 — won't save Floridians any money and could expose patients to an onslaught of counterfeits. Lawmakers should halt their effort before wasting any more time on it.

Federal officials have long warned against the dangers of drug importation. As former HHS Secretary Mike Leavitt noted, it's "impossible… to certify that importation of medicines from unregulated sellers is safe."

His concerns are justified. Counterfeit drugs plague foreign markets. One in 10 drugs from low- and middle-income countries is illicit.

While Americans typically assume that drugs shipped to the United States from Canada are safe, this isn't always true.

One big reason? A large percentage of drugs coming from "Canadian" online pharmacies actually originate in countries with subpar regulatory standards. In one bust, FDA officials found 85 percent of drugs ordered from "Canada" didn't actually come from there. Instead, these drugs came from 27 other countries, including India and Iran.

These drugs are often dangerous. Just last year, U.S. prosecutors fined Canadadrugs.com, an internet pharmacy that billed itself as Canada's largest, $34 million for selling two cancer drugs with zero active pharmaceutical ingredients. This means that many patients unknowingly paid for medicines that didn't do anything to treat their conditions.

Counterfeits coming from Canada have been a big issue in the Sunshine State. The FDA has identified dozens of counterfeit drugs coming into Florida from foreign pharmacies.

Imported drugs are especially dangerous today given the rising prevalence of fentanyl, an opioid 50 times more potent than heroin, in counterfeits. In 2016, officials seized 130,000 counterfeit pills laced with fentanyl in Alberta. This was the largest fentanyl pill seizure in Canada's history.

It's impossible for the FDA to ensure the safety of drugs coming from outside America's borders. And Canada has no intention of securing America's drug supply. In fact, Health Canada has explicitly stated they “[do] not assure that products being sold to U.S. citizens are safe, effective, and of high quality, and [do] not intend to do so in the future."

This echoes the statement Canada's then-health minister, Ujal Dosanjh, made in 2004 when U.S. lawmakers last seriously considered importation. "It is difficult for me to conceive of how a small country like Canada could meet the prescription drug needs of approximately 280 million Americans without putting our own supply at serious risk," he said. “Canada cannot be the drugstore of the United States."

Some Floridians might accept these risks if importation would reduce drug spending. But it won't.

According to number-crunchers at the Department of Health and Human Services, legalizing drug importation would only decrease drug spending by a fraction of 1 percent.

The price disparity between drugs sold at U.S. pharmacies and their foreign competitors isn't significant. While new, specialty pharmaceuticals tend to cost less outside the United States, such drugs comprise less than 10 percent of the market. Generic drugs, on the other hand, tend to cost less in the United States thanks to robust competition.

Other states have tried large-scale drug importation, with predictable results. About 15 years ago, lawmakers in Illinois, Wisconsin, Missouri, Kansas, Vermont, and Hawaii attempted a scheme similar to HB 19. But after mounting safety concerns and access delays — and little savings — those states scrapped their efforts.

Florida legislators should keep foreign drugs out of the Sunshine State.