Trump opens door to drug imports from Canada – By Tom Howell Jr. (The Washington Times) / July 31 2019
HHS offers two pathways, in notable evolution
The Trump administration opened the door Wednesday to the importation of drugs from Canada and other foreign markets, marking a historic step for federal regulators as President Trump’s other drug-pricing ideas falter.
The Health and Human Services Department outlined two pathways for bringing in the drugs. One proposed rule would allow states, drug wholesalers or pharmacists to seek federal approval of plans to import drugs from Canada that are safe versions of FDA-approved drugs.
The second route, through draft guidance, would let companies bring in versions of drugs they sell abroad, using a special national code to offer a lower U.S. price than what their current, Byzantine distribution contracts require.
It’s a notable evolution for a Republican administration. For years, the GOP has looked askance at drug importation, citing safety concerns, and the powerful pharmaceutical lobby has pushed back, too.
Now, the administration says there is a pathway to importation.
“We can be convinced,” Health Secretary Alex Azar said. “We’re saying here’s the criteria, here’s the roadmap.”
Pressure had been bubbling up from the states.
Florida Gov. Ron DeSantis, a Republican and key Trump ally, pushed for a state law on importation and nudged the White House on the idea, which dovetails with the president’s belief that U.S. consumers are being taken for a ride by Big Pharma.
“President Trump has been clear: for too long American patients have been paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices,” Mr. Azar said.
The plan is riling the pharmaceutical industry, which argues it relies on higher U.S. prices to fuel research into the latest cures.
The Pharmaceutical Pharmaceutical Research and Manufacturers of America, a key lobby, says importation will invite a host of problems, including importation schemes that worsen the opioid crisis or jeopardize safety.
“The administration’s importation scheme is far too dangerous for American patients,” PhRMA President and CEO Stephen J. Ubl said. “There is no way to guarantee the safety of drugs that come into the country from outside the United States’ 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.”
Yet Mr. Trump has been willing to needle the industry in his pursuit of lower drug prices, particularly as his administration struggles to push other ideas for slashing costs.
Mr. Trump’s plan to force companies to disclose list prices in TV ads was blocked by a federal judge, and he recently withdrew a plan to pass drug rebates directly to Medicare recipients, fearing it would increase seniors’ Part D premiums.
Mr. Azar said the administration will press on and remain receptive to bold and innovative ideas.
“We heard about the pain Americans are feeling at the pharmacy counter,” Mr. Azar said. “We learned that this was impacting Americans’ health, and we’re taking action.”
Trump officials said their plan is structured to help a broad swath of patients. For instance, people who rely on biologics like insulin cannot rely on demonstration projects from states or companies, though the administration says those drugs can flow through the second pathway, which allows companies to use special pricing codes.
The secretary also said he’s had conversations with his Canadian counterpart to try and head off any reservations the northern neighbor might have about the plan.
A coalition of Canadian pharmacy and health groups are sounding the alarm, however, fearing the flow of drugs to the U.S. could exacerbate problems in their own supply chain.
“We request that Health Canada provide clarity and assurances to Canadians that U.S. legislation will not inadvertently disrupt Canada’s pharmaceutical supply and negatively impact patient care through greater drug shortages,” the group wrote in a July 25 letter to Health Minister Ginette Petitpas Taylor.
In this Wednesday, July 10, 2019, file photo, President Donald Trump speaks about kidney health, accompanied by Health and Human Services Secretary Alex Azar, left, in Washington. Azar says he and Trump are working on a plan to allow Americans …
https://www.washingtontimes.com/news/2019/jul/31/donald-trump-opens-door-drug-imports-canada/
