WASHINGTON — Trump administration officials gave a few more details Friday on President Trump’s plan to import lower-priced prescription drugs from Canada, but offered less information about another initiative the president discussed in a speech on Thursday: cards worth $200 to be distributed to Medicare beneficiaries to help them pay for prescription drugs.
“The FDA issued a final rule allowing proposals for importation of certain drugs from Canada by states, as well as the District of Columbia, territories, tribes and in certain circumstances, pharmacies and wholesalers,” Brian Harrison, chief of staff at the Department of Health and Human Services (HHS), said on a phone call with reporters. “These programs will be managed by a program sponsor, which will be authorized by the FDA to facilitate the importation of certain prescription drugs approved in Canada and appropriately labeled and approved for use in the U.S.”
“Eligible drugs would undergo testing for authenticity and degradation and to ensure the drugs meet established specifications and standards, after which they would be re-labeled with FDA-approved labeling,” said Harrison. “FDA’s review would assure these products present no additional risk to patients.”
In addition, Harrison said, “the FDA published final guidance that describes the procedure for a drug manufacturer to obtain a National Drug Code for certain prescription drugs originally manufactured and intended for sale in a foreign country… This could allow companies to compete through lower costs in ways that just aren’t possible in today’s incredibly complex and often distortionary system where drugs too rarely compete on price.”
The agency also is soliciting requests for proposals in two other areas, including for programs allowing Americans to obtain insulin at lower cost through reimportation. “The insulin subject to these programs will have to be FDA-approved, or licensed and manufactured in the United States,” said Harrison. “The potential for savings here is huge … Americans pay significantly more for insulin than patients in other countries do — as much as two or three times more depending on which estimates you look at.”
The other area for proposal involves plans to import lower-cost FDA-approved prescription drugs individually from an authorized, state-licensed pharmacy. The drugs “could be imported from an acceptable foreign source, including the European Union, the United Kingdom, Switzerland, Canada, and certain other countries we’ve defined,” Harrison said.
Harrison also discussed a proposed rule from the Health Resources and Services Administration to “pass on the steep discounts given to community health centers via the 340B drug pricing program for insulin and ingestible epinephrine to certain low-income Americans.” Under the proposed rule, which is currently out for comment, health centers would be required to provide insulin and epinephrine at their 340B acquisition cost to patients who have incomes below 350% of the federal poverty level ($44,660 for an individual or $91,700 for a family of four) “and also have a high cost-sharing requirement, have a high deductible, or who have no insurance,” Harrison explained. “Their cost for these drugs can be as low as a few dollars, or even pennies, plus a very small minimal administrative fee.”
Currently, more than 1,300 health centers with more than 9,000 delivery sites participate in the 340B program and treat many patients with chronic illnesses, including more than 2.7 million patients with diabetes, he said.
During a question-and-answer session, reporters asked several questions about the $200 card proposal, including where the money would come from; the cards would go out to 33 million Medicare beneficiaries at an estimated cost of $6.5 billion. “The details around the offset for the $200 cards are still being worked out, and I understand the White House hopes to put out more details sometime in the near future,” said a senior administration official. The White House said yesterday that the cards ostensibly would be financed via savings generated through Trump’s “most favored nation” executive order allowing Medicare to pay no more for certain prescription drugs than the price paid by other developed countries. That executive order has not yet been implemented, however, and court challenges are expected.
Asked about the timing of sending out the cards before Election Day, Harrison said that wasn’t a consideration. “They will be going out as soon as mechanically possible, but not all cards are going out prior to the election, and it is not being timed that way,” he said. “It will be done over the course of time.”
Regarding drug reimportation, officials couldn’t say exactly how much money the plan would save, although “Florida’s concept paper for their program, for instance, suggests they could see savings of 50% or more on costly HIV drugs,” said Harrison. However, “there’s no way to go through a full actuarial analysis until we have a plan that’s fully vetted by our colleagues at the FDA,” a senior administration official said. Harrison added that “given the massive price differentials between what foreign patients are having to pay for the same drugs as American patients, we’re very confident the savings could be very substantial.”
Any large-scale reimportation of drugs from Canada would, of course, require permission from the Canadian government, something which does not as yet appear to have been obtained. “That is the part of the puzzle the administration is not talking about,” a source close to HHS told MedPage Today in an email. “Canada has said repeatedly ‘No’ to importation of Canadian drugs to the U.S. So that makes U.S. plans moot. Individual importation can continue to go on, but not institutional, as this regulation tries to set up. So the regulation is worth nothing regarding actual importation.” Canadian pharmacists, patients, and doctors’ groups have expressed concern that reimportation could exacerbate drug shortages in their country, the Washington Post reported last year.
Emails to HHS and Canadian health officials asking whether Canada had approved of such a reimportation plan were not immediately returned.
Source: MedicalNewsToday.com
