The Trump administration said Wednesday it will create a way for Americans to legally and safely import lower-cost prescription drugs from Canada for the first time, reversing years of refusals by health authorities amid a public outcry over high prices for life-sustaining medications.
The U.S. Department of Health and Human Services said it and the Food and Drug Administration will propose a rule that will allow it to authorize states and other groups to pursue pilot projects related to importing drugs from Canada.
The second pathway would allow manufacturers of FDA-approved drugs to import versions they sell in foreign countries, using a new national drug code that would potentially allow them to offer lower prices than those required by their current contracts with distributors, provided they could demonstrate to the FDA that the foreign versions were the same as the USA versions. Grassley said on Twitter that importation would lower prescription drug costs, and all drugs from overseas must be verified as safe by the FDA.
A new proposal from the Trump administration would take steps toward allowing importation of drugs from other countries.
"The landscape and the opportunities for safe linkage between drug supply chains has changed", Azar said.
However, Stephen Ubl, president of trade group the Pharmaceutical Research and Manufacturers of America, called the proposal "dangerous".
Under the first pathway, HHS and the Food and Drug Administration would use authority provided under current federal law to authorize pilot projects by states, wholesalers and pharmacists outlining ways to import drugs from Canada that are versions of FDA-approved products manufactured in ways consistent with USA regulatory standards. For years, the GOP has looked askance at drug importation, citing safety concerns, and the powerful pharmaceutical lobby has pushed back, too. "Drugs coming through Canada could have originated from anywhere in the world and may not have undergone stringent review by the FDA".
"We support the President and Secretary's efforts to bring down drug prices for Americans", added Acting FDA Commissioner Ned Sharpless. Wall Street analysts said importation was far from being put into place and was limited to certain drugs from Canada.
The 2003 Medicare Modernization Act allows states to import cheaper drugs from Canada, but only if the HHS secretary verifies their safety. "The agency is interested in considering any reasonable that maintains the bedrock of safety and efficacy for the American consumer". He and Democratic presidential candidate Sen. Bernie Sanders (I-Vt.) noted the disparity in USA and Canadian prices.
The importation idea has backers across the political spectrum.
The announcement marked the latest shift by the Trump administration on the decades-old debate about formally allowing Americans to buy drugs from Canada, where prices are significantly lower.
Many drug purchase agreements in Canada forbid the re-export of drugs to other countries, according to a Canadian government memo obtained by Reuters.
Canadian health officials have expressed concerns about USA importation, Azar said, but he added that it is up to states that want to start a program to work to overcome the obstacles, such as a lack of supply, Canadians foresee. Separately, the FDA will work on safety guidelines for drug manufacturers who want to import any drugs they sell in foreign countries to the US market.
Some experts have been skeptical of allowing imports from Canada, partly from concerns about whether Canadian suppliers have the capacity to meet the demand of the much larger USA market.
But consumer groups have strongly backed the idea, arguing that it will pressure US drugmakers to reduce their prices. "Importation runs directly counter to the efforts of many regulators, the pharmaceutical industry and congressional intent - and is simply not worth the risk".
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