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Trump Administration Takes First Step to Allow Drug Imports From Canada


The Trump administration said on Wednesday that it would move forward with plans to allow states to safely import prescription drugs from Canada, for the first time.

The decision is an unusual one for a Republican administration. Progressives have long supported such a policy, but the pharmaceutical industry vehemently opposed drug imports by claiming they were unsafe. Food and Drug Administration commissioners had also opposed importing drugs intended for overseas use, citing safety issues.

In a telephone call with reporters Tuesday, Alex M. Azar II, the secretary of health and human services, described the announcement as momentous. “For the first time in history, H.H.S. and the F.D.A. are open to importation as a means to lower drug prices,” he said.

He also said, “We will not take steps that would put patients or our drug supply at risk.”

First announced in July, the proposal is still a long way from affecting consumers’ wallets. States will have to submit their own plans to the federal government for approval, to see if they are both safe and would significantly reduce costs.

Importantly, many of the most expensive drugs are excluded from this proposal, including insulin and biologic drugs like Humira and other injectable drugs. A 2003 law limited the types of drugs that could be imported.

A proposal by the state of Florida, made public in August, listed drugs that could yield savings if they were imported from Canada, including brand-name drugs to treat H.I.V., hepatitis C and multiple sclerosis.

A separate plan that would allow manufacturers to import into the United States their own drugs that were intended for sale in other countries would apply to a wider range of products. But under that proposal, manufacturers would have to agree to participate. Federal officials have said that some drug makers have expressed interest in doing so, without providing specifics.

The drug industry’s main lobbying group, the Pharmaceutical Research and Manufacturers of America, expressed skepticism about the plans, and said it was still reviewing the details.

“At a time when there are pragmatic policy solutions being considered to lower costs for seniors at the pharmacy counter and increase competition in the market, it is disappointing the administration once again put politics over patients,” the group’s president and chief executive, Stephen J. Ubl, said in a statement.

Mr. Azar said that the announcement this week was just the beginning and that if the programs were successful, they could be expanded.

“I would envision that as we demonstrate the safety as well as the cost savings from this pathway that there can be basically a pilot and a proof of concept that Congress could then look to,” he said.

The Trump administration said it did not have estimates for any consumer or taxpayer savings, because states had not yet submitted any plans. The proposal also noted that running the programs would cost money. “As we lack information about the expected scale or scope of such programs, we are unable to estimate how they may affect U.S. markets for prescription drugs,” the proposal said.

As public outrage over high drug prices has mounted, state leaders from both parties have considered importing drugs from Canada as a way of addressing the issue. The Florida governor, Ron DeSantis, favors such a plan, and President Trump has repeatedly said he will help make it happen. Other states, including Colorado, Vermont and Maine, also favor importation.

In a news conference Wednesday with Mr. Azar, Governor DeSantis said the plan was not a “silver bullet,” but was “an important step.”

“I’d much rather be here, moving forward,” he said, “than just being on the sidelines chirping, saying, ‘why doesn’t someone do something about it?’”

Candidates and lawmakers in both parties are competing to show voters they are serious about lowering drug prices. Last week, the House passed legislation that would allow the federal government to negotiate drug prices with pharmaceutical manufacturers, an ambitious move that delivered on a key campaign promise but is unlikely to be taken up in the Republican-controlled Senate.

Administration officials have struggled to show progress on this issue. In July, the administration abandoned a proposal that would have given Medicare beneficiaries drug discounts at the pharmacy counter, but which also would have raised their premiums. That same month, a federal judge threw out a rule that would have required pharmaceutical companies to list the price of their drugs in television advertisements.

The policy supporting importation represents an about-face for Mr. Azar, who previously described such importation programs as “gimmicks.”



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