This week, the Trump administration formally announced support for not only state prescription drug importation programs, but also HHS Secretary Alex Azar’s own importation plan. Until this week, it was known that Trump had instructed Secretary Azar to work with Republican Governor Ron DeSantis of Florida to help implement its new law to permit wholesale drug importation from Canada for public payers, which also includes importation from other countries for the private market. Now, there is real movement.
Before diving into Trump’s drug importation plan more fully, please take note that this plan actually allows for the importation of what the FDA has called “foreign unapproved drugs,” ones that they have said they don’t want Americans ordering online and importing for their own use. These drugs, as explained below, are safe and effective foreign brand versions of the same drugs sold here. This recognition of equivalent brand drug safety is a step in the right direction.
The reality is that Americans have already been importing medications from foreign pharmacies because of substantially lower prices for many years, and the law is currently flexible to allow them to do so. This new momentum on importation should be a wakeup call to:
- Provide Americans with the best possible guidance to import medicine from other countries in cases when they can’t afford the prices here;
- Warn Americans not to buy medication online unless the online pharmacy is properly credentialed.
Trump’s drug importation plan includes two channels of importation
The first proposed channel of prescription drug importation is already codified in law: Section 804 of the Food, Drug and Cosmetic Act. Section 804 states that the importation of lower-cost medication from Canada is legal if the HHS Secretary certifies that the importation would pose no additional safety risk and achieve substantial savings.
What’s new is that until the Trump administration, the FDA always affirmed its opposition to implementing importation under Section 804 for safety reasons. Today, Secretary Azar, former Eli Lilly USA president and outspoken opponent of importation, says it can be done safely. What’s more: the acting FDA commissioner, Ned Sharpless, MD, seems to be on board as well.
The world is upside down.
Under the wholesale drug importation law in Florida, and those in Vermont, Colorado, and Maine, the states must bring their plans to HHS, per Section 804, to prove the safety and savings. Until the Secretary gives the green light, the states won’t actually be importing from Canada. Apparently, Azar is ready to give the green light.
The second channel of importation, which is separate from the state drug importation programs, would allow drug companies to import lower-cost foreign version of their own FDA-approved drugs. These imports could come from any country, not just Canada. This second importation idea is not new. It was Azar’s idea from last summer. It was also proposed a year before that by Thomas J. Bollyky from the Council on Foreign Relations and Dr. Aaron Kesselheim from Harvard.
People are rightfully wondering why drug companies would do this. Sell lower-cost versions of their own drugs. What does that even mean?
Azar makes the point that some drug companies have arrangements with third parties, such as PBMs and distributors, that lock them in to higher prices with “FDA-approved” drugs. But for “foreign versions” of FDA-approved drugs, this is not the case. Take AstraZeneca’s Nexium. The FDA-approved version of a 40 mg pill is in capsule form. The foreign version sold in the EU is a tablet. The implication from Azar might be that AstraZeneca could sell the tablet at lower cost and the savings would be passed on.
The bigger idea is that foreign versions of FDA-approved drugs for which there is no competition could bring competition to the market. The quintessential example is Daraprim of Martin Shkreli fame.
The FDA-approved Daraprim, manufactured by Vyera Pharmaceuticals, costs over $750/pill.
The version in the UK, manufactured by GlaxoSmithKline, sells for about $6/pill in that country.
Under Azar’s new plan, Glaxo could sell its Daraprim in the U.S.
Foreign versions of FDA-approved drugs are also called “foreign unapproved drugs” by the FDA
I don’t want this part of Azar’s plan to go misunderstood. For years, the drug companies and the FDA have said Americans are threatened by “foreign unapproved drugs” ordered online and imported for personal use. As I see it, they used this phrase “foreign unapproved drugs” because it sounds scary. But such drugs sold from licensed pharmacies are actually approved drugs in the countries where they are dispensed. In fact, for many years Americans have been importing lower-cost, FDA-approved drugs and foreign versions of FDA-approved drugs from licensed pharmacies in Canada and elsewhere. They often do so by ordering them from international online pharmacies.
Now, Azar and company are saying foreign unapproved drugs (meaning foreign versions of FDA approved drugs) can be exceedingly safe.
Personal Drug Importation Not Mentioned
Any discussion of Americans buying (importing) medications directly from foreign pharmacies, which they already do, was conspicuously missing from Trump’s plan – but the issue will have to come to the surface. Section 804 clearly allows for the drafting of regulations by the Secretary of Health and Human Services to help people who choose to import lower-cost medication for personal use as long as it doesn’t represent an unreasonable risk to the patient. Now is the time to do so. We’d love to help!
See a report by Prescription Justice on executive actions to expand safe personal drug importation via properly accredited international online pharmacies.Tagged with: Alex Azar, Donald Trump, Food Drug Cosmetic Act, Section 804