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1 August 2019AmericasSarah Morgan

Trump confounds big pharma with low-cost drugs import plan

In a bid to lower drug prices for American patients, the Trump administration has proposed plans to allow the importation of cheaper drugs from Canada and other countries.

Yesterday, July 31, the US Department of Health and Human Services (HHS)  announced it and the Food and Drug Administration (FDA) would take a two-pronged approached.

First, the HHS and FDA will propose a rule to authorise pilot projects developed by states, wholesalers and pharmacists, outlining how they would import drugs from Canada.

For authorisation, the projects would need to “achieve significant cost savings to the American consumer”.

On the second prong, the FDA will allow manufacturers to import drugs made in other countries for sale in the US.

“Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require,” said a release from the government agencies.

In a  speech made last year, US President Donald Trump spoke out against importing prescription drugs.

“We want our drugs to be made here. When you talk prescription drugs, we don’t like getting them from foreign countries. We don’t know what’s happening with those drugs, how they’re being made. Too important,” Trump said.

HHS secretary Alex Azar has also  previously dismissed drug importation as a “gimmick”.

In May last year, Azar said: “On top of that, the last four FDA commissioners have said there is no effective way to ensure drugs coming from Canada really are coming from Canada, rather than being routed from, say, a counterfeit factory in China … The last thing we need is open borders for unsafe drugs in search of savings that cannot be safely achieved.”

‘Too dangerous’

The importation proposals have been met with criticism from the pharmaceutical industry.

Pharmaceutical Research and Manufacturers of America (PhRMA), which represents US biopharmaceutical research companies,  claimed that the importation scheme is “far too dangerous for American patients”.

Stephen Ubl, CEO of PhRMA, said: “There is no way to guarantee the safety of drugs that come into the country from outside the US’ gold-standard supply chain. Drugs coming through Canada could have originated from anywhere in the world and may not have undergone stringent review by the FDA.”

He added that law enforcement has repeatedly warned that important schemes could worsen the opioid crisis and that Canadian officials have said that the policy is unworkable.

Meanwhile, in Canada, 15 organisations sent a  letter to Canada’s Minister of Health Ginette Petitpas Taylor to express concern over US legislation that allows the importation of cheaper drugs.

“The Canadian medicine supply is not sufficient to support both Canadian and U.S. consumers,” said the letter. “The supply simply does not and will not exist within Canada to meet such demands.”

The FDA has delivered historic levels of generic drug approvals during the Trump administration.

According to the FDA and HHS release, the Council of Economic Advisors estimated the savings generated from generic approvals in the first 18 months of the Trump administration to be $26 billion.

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