Trump Administration Unveils Drafts To Create Dual Pathways Easing Way For Prescription Drug Importation
The proposed rules would allow states, drug wholesalers, or pharmacies to apply to import certain drugs from Canada. The policy would also let drugmakers import their own products sold in other countries.
The Hill:
Trump Administration Proposes Limited Drug Importation From Canada
The Trump administration is laying the groundwork to allow some cheaper prescription drugs to be imported from Canada. The administration is issuing a proposed rule, along with a proposed guidance for the drug industry, that will allow states, pharmacies, wholesalers and manufacturers to import prescription drugs if they meet conditions designed to ensure that the importation poses no additional risk to safety and will save consumers money. (Weixel, 12/18)
Stat:
Trump Unveils Early Draft Policies For Drug Importation
The drafts create two pathways for importation. One would let states, drug wholesalers, or pharmacies apply to import certain drugs from Canada, pending a sign-off from the Department of Health and Human Services. A second would let drug makers import their own products sold in other countries. Both must still undergo a formal regulatory review, a process that can take months or even longer. But the administration insists it is moving as fast as the law will allow. (Florko, 12/18)
The New York Times:
Trump Administration Takes First Step To Allow Drug Imports From Canada
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. (Thomas, 12/18)
The Wall Street Journal:
U.S. Advances Plan To Allow Imports Of Certain Drugs In Bid To Cut Prices
Opening up U.S. markets to imported drugs is a central plank of the administration’s effort to tackle drug prices, and federal officials say it would let Americans attain the same cost savings as consumers in other countries. It is also likely to be a major talking point for President Trump as the 2020 election kicks off. When the administration outlined its plan in July, industry groups argued it could undermine patient safety by letting in substandard or counterfeit drugs. (Armour and Burton, 12/18)
Modern Healthcare:
HHS Moves Forward With Plan To Import Prescription Drugs
HHS is legally allowed to approve importation programs as long as the agency can certify that the program would present no additional safety risk and would save consumers money. It remains unclear from preliminary analyses whether prescription drug importation programs will save substantial amounts of money, and Azar hinted on a call with reporters Tuesday evening that HHS has several options in how it defines the cost savings requirement. "We will seek comment on how that should be interpreted," Azar said. (Cohrs, 12/18)
The Associated Press:
Trump Administration Advances Prescription Drug Import Plan
It's unclear that either idea will have an impact on patients' costs ahead of the 2020 election, but the Trump administration has advanced beyond its predecessors in trying to set up a supervised system for importing drugs. Medicines cost less in other advanced countries because the governments take an active role in setting prices. “A new pathway for importation can move us to a more open and competitive market,” Health and Human Services Secretary Alex Azar said. (12/18)
The Washington Post:
Trump Administration Unveils Plan To Allow States To Buy Cheaper Drugs From Canada
It also remains unclear whether the plan will survive expected legal challenges from the pharmaceutical industry, and whether it will be possible to import significant quantities of drugs from Canada. The Canadian government has fiercely pushed back against importation proposals, warning that the drug supply for Canada’s 37 million residents cannot possibly fulfill the demands of the much larger U.S. market and that allowing importation would cause severe drug shortages for Canadians. (Abutaleb and McGinley, 12/18)
The Washington Examiner:
Trump Administration Moves To Allow Drug Importations From Canada
The plans have been in the works for months, and Trump promised a plan “soon” in November. Azar said the proposals announced Wednesday are “largely very consistent” with an action plan his department put out in July but that this is the “fleshing out of all of the legal and implementation parameters of it.” HHS will not allow biologic drugs, including insulin, to enter the U.S. from a foreign country. He said, though, that based on the success of the programs early on, Congress could consider later whether to permit some biologics, some of the most expensive drugs, to come to the U.S. from Canada. (Morrison, 12/18)
Reuters:
Trump Administration Moves Forward Rule To Import Medicines
Both the House of Representatives and the Senate are putting forth drug pricing bills that contain some of the proposals Trump has advocated for, such as indexing public drug reimbursements to foreign drug costs. However, Trump has said he will veto the Democrat-led House bill if it comes to his desk, on the grounds that it would slow down innovation. (Erman and O'Donnell, 12/18)
Politico:
Trump Plan Lets States Import Canadian Drugs
Canada and its provinces get drugs at lower cost as a result of price regulation and negotiations with drug companies. There's no way to estimate how much Americans might save from the Trump plan because it will depend in part on importation applications HHS will receive, Azar said. (Owermohle and Karlin-Smith, 12/18)
