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Colorado legislation would expand foreign drug imports

April 7, 2021 GMT

DENVER (AP) — Colorado lawmakers are considering a bill to add more countries to a state program that imports prescription drugs from Canada.

The state House Health and Insurance committee passed a bill Wednesday that would expand the program if the federal program is also increased.

In 2020, under former President Donald Trump, Secretary of Health and Human Services Alex Azar implemented a rule to allow states to submit import program proposals to the Food and Drug Administration for review and authorization.

Colorado passed its Canadian import bill in 2019, and the state is still in the process of designing a program to be submitted for federal approval. More than 12 states are eyeing similar legislation, said Democratic Rep. Karen McCormick, one of the Colorado bill’s sponsors.

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Colorado and Florida are the furthest along but no states are actively expanding their programs yet, according to Kim Bimestefer, executive director of Colorado’s Department of Health Care Policy & Financing.

“We would prefer to be in the driver’s seat,” said Bimestefer, who testified in support of the bill. “We would prefer to influence the (federal government) on behalf of what Colorado needs rather than following a Florida.”

The Senate bill passed the House committee on a 8-5 vote Wednesday and will go to the House floor for debate.

Bimestefer said it would address an equity issue among low-income, rural and minority Colorado residents who struggle the most with drug affordability. Currently, one in 10 Colorado residents can’t afford their prescription drugs, she said.

In her testimony, the executive director said calling foreign drug safety into question is a “fear play.” She said 80% of drug ingredients and 60% of completed drugs are already coming from FDA-approved manufacturers abroad.

The bill would add a third check to the current pharmaceutical “track and trace” requirements.

Bimestefer told the committee that the reason for costly U.S. drug prices is two-fold. One is because of long-term patent protections for drug manufacturers that have prevented generic forms of medications to come to market. For example, Humira, a drug used to treat autoimmune diseases, has extended its patent for 23 years, Bimestefer said.

The other issue she cited was that while other countries negotiate drug prices with manufacturers during market approval, the U.S. does not.

“We feel strongly that it will create the pressure to bring down prices ... and stop this country from creating ridiculous levels of profits in prescription drugs that other countries simply do not tolerate,” Bimestefer said of the Colorado bill.

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Shabbir Safdar, executive director of the Partnership for Safe Medicines, a group of public health trade associations and non-profits, opposes the bill and said “we’re implementing a program that is simply not going to happen” because of Canada’s opposition.

In a November statement, days before the Trump administration’s import program would take effect, Canada’s Ministry of Health said that certain drugs would be prohibited from being distributed outside of Canada if it would cause or worsen a shortage of the drug.

“Canada has repeatedly stated that this rule would not be an effective approach to reducing drug prices in the U.S. since the Canadian market is small, representing only 2% of global pharmaceutical sales compared to 44% for the U.S.” according to a statement from Patty Hajdu, Canada’s minister of health.

A report from Kaiser Health News found that one-third of the groups involved with the Partnership for Safe Medicines received funding from Pharmaceutical Research and Manufacturers of America, or PhRMA, the largest pharmaceutical lobbying group.

Safdar argued that there’s a lack of security for the imported drugs due to Canada not having the same “track and trace” program.

“Because of the history of counterfeits, especially from wholesalers in Canada into America and specifically Colorado, it is not safe to implement these programs,” Safdar said.

Lauren Reveley, drug importation program manager at Colorado Department of Health Care Policy & Financing, who is in charge of designing and implementing the Canadian program, said the bill would not change domestic drug testing requirements.

“It does not introduce opportunities for counterfeit drugs to be placed in the supply chain any more than what’s possible to occur today,” Reveley said.

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Nieberg is a corps member for the Associated Press/Report for America Statehouse News Initiative. Report for America is a nonprofit national service program that places journalists in local newsrooms to report on undercovered issues.