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FDA Opens Door to Importing Drugs

24 July 2018

Jill Wechsler / BioPharm International

Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines.

For years, consumer advocates and state officials have pushed for access to less expensive prescription medicines available overseas, only to meet stiff resistance from FDA and government health authorities claiming that such action could bring unsafe and harmful products into the United States. This opposition has come from both Democratic and Republican administrations, bolstered by evidence that drugs supposedly from Canada or Europe are often of unknown origin and are shipped by unscrupulous website operators.

Now rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines. With support from Health and Human Services (HHS) secretary Alex Azar, FDA commissioner Scott Gottlieb is forming a work group to consider strategies for importing prescription drugs from other countries. Such action would be in response to a “dramatic price increase” on a product that has no competition and thus threatens patient access. Importing would be limited to off-patent, off-exclusivity sole-source products where quality, approved alternatives may be available overseas.

The work group will explore how enforcement discretion could lead to importation of drugs that would be suitable substitutes for an FDA-approved version of a medically-necessary medicine. Key topics to consider are the relevant statutory and regulatory requirements for advancing an import policy; how to define an “access dislocation” that could lead to serious shortages; and how FDA will assess the safety, effectiveness and labeling of a foreign-approved drug to ensure patient safety. Any authorized import under this framework would be temporary, Gottlieb emphasized, and policies would aim to prevent the import of counterfeit or unsafe drugs.

Even with these caveats, manufacturers strongly oppose the plan, as seen in the alarm sounded by the industry-backed Partnership for Safe Medicines over widespread illegal importing of counterfeit fentanyl products and criminal organizations operating illegal pharmacy websites offering lethal therapies to American consumers. The Association for Accessible Medicines (AAM), which represents generic-drug companies, advises FDA and HHS to examine the factors leading to sole-source, off-patent drugs in the first place, which it blames on too-low generic drug prices that limit competition in certain markets.

State and local governments have long sought to establish drug importing programs to obtain discounts for state health programs and public employee health plans, and Congress passed a law in 2003 that allows drug importing from Canada if HHS certifies that such action doesn’t increase safety risks for consumers. The feds have never provided that support, although FDA usually permits individuals to purchase foreign prescription drugs for personal use. Vermont is taking a new tack, with a new law that establishes a state wholesale bulk purchasing program to bring in less costly medicines from Canada, as part of broader legislation requiring drug manufacturers and insurers to disclose high prices of new drugs. It will be ironic if the current Republican administration authorizes similar action, altering long-held regulatory opposition to importing unapproved drugs.

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