[Ip-health] Is the FDA Is Misleading Congress About the Safety of Imported Medicines

Gabriel Levitt gabriel.levitt at gmail.com
Mon Apr 1 16:58:05 PDT 2019


https://www.thenation.com/article/canarx-prescriptions-drug-importation-fda/

*Is the FDA Is Misleading Congress About the Safety of Imported Medicines*

*Prescription drugs can cost 80% less in Canada, Australia and the UK—why
isn’t the FDA supporting safe importation?*

The one issue that unifies our divided America is the high cost of
prescription drugs. Congress has taken the hint, decrying the greed of the
pharmaceutical industry at hearings that seem to be held almost weekly; and
sounding the alarm for immediate action, which seems to never come. The
Kaiser Family Foundation
<https://www.kff.org/health-costs/poll-finding/kff-health-tracking-poll-february-2019-prescription-drugs/>
recently
reported that one in four Americans struggle to fill their prescriptions
because of cost, which can often lead to illness or even death
<https://www.nytimes.com/2017/04/17/well/the-cost-of-not-taking-your-medicine.html>.
We are in the midst of a public health crisis.

One of the solutions currently working its way through Congress
<https://www.congress.gov/bill/116th-congress/house-bill/447> would permit
patients to obtain lower-cost medication from pharmacies in Canada and
other countries, where drug prices are frequently as much as 80% lower than
those at US pharmacies
<https://www.pharmacychecker.com/news/american-seniors-save-80-percent-medication/>.
Americans haven’t waited for Congress to act, however: Despite the fact
that it’s federally prohibited under most circumstances, about 20 million
Americans
<https://khn.org/news/faced-with-unaffordable-drug-prices-tens-of-millions-buy-medicine-outside-u-s/>
have
already imported medicines for personal use because of cost. To import,
some travel to Canada and Mexico, while others order online or through
programs connecting them with international pharmacies. For many, it’s
great savings, but for others it’s their only option.

While individuals are never prosecuted
<https://www.washingtonpost.com/national/health-science/cities-counties-and-schools-sidestep-fda-canadian-drug-crackdown-saving-millions/2017/12/08/b2de0ce2-dc00-11e7-a241-0848315642d0_story.html?utm_term=.12376cb5ccb0>
for
this technical violation of law, the FDA’s non-enforcement policy does not
preclude the agency from harassing businesses
<https://khn.org/news/fda-raids-florida-stores-that-consumers-use-to-buy-drugs-from-canada/>
that
facilitate safe personal drug importation. Where serious dangers lurk, the
FDA does and should take enforcement actions, including against rogue
online pharmacies, opioid imports, and counterfeit drug sales. But that
focus and enforcement activity, funded by public monies, should not be
misused to protect the profit margins of drug companies.

On February 27th, in a hearing
<https://www.washingtonpost.com/national/health-science/cities-counties-and-schools-sidestep-fda-canadian-drug-crackdown-saving-millions/2017/12/08/b2de0ce2-dc00-11e7-a241-0848315642d0_story.html?utm_term=.12376cb5ccb0>
of
the House Appropriations subcommittee responsible for FDA funding,
Congresswoman Chellie Pingree asked then FDA Commissioner Scott Gottlieb
for his thoughts on drug importation from Canada, noting that people from
Maine can buy much lower cost medicines across the border [watch from
1:34:23 for this exchange]. Commissioner Gottlieb asserted that people who
buy medications while in Canada are safe.

In contrast, Gottlieb voiced his “deep concerns” with online pharmacies
“purporting to source their drugs in Canada or other First World markets
but are not.”

“We are seeing a lot of counterfeit drugs being sold through those
channels,” asserted Gottlieb, going on to say that there is “a lot of
investigative activity and some fairly egregious things [the FDA] are
finding when we look at these websites… so we have deep public health
concerns.”

The commissioner’s remarks would lead Congress to believe that the FDA is
spending taxpayer dollars investigating and taking actions against
counterfeit drug sales, rogue online pharmacies and serious threats to the
public health. Yet a day before that testimony, the FDA issued a warning
letter
<https://www.nytimes.com/2019/02/28/health/canada-prescription-drugs-fda.html>
to
a company called CanaRx Services, Inc. to stop facilitating imports of
medicines. In its press release
<https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632360.htm>,
the FDA weaves a sinister narrative, using language that is eerily similar
to that employed by organizations and experts funded by drug companies
<https://www.tarbell.org/2019/02/heres-how-the-drug-industry-funds-experts-to-discredit-efforts-to-lower-prices2/?ref=featured>
:

“Operations like CanaRx use their names to imply that patients are
receiving medicines approved in Canada, when it’s likely that patients are
receiving medicines from other countries, and which may be sub-potent,
super-potent or counterfeit.”

Which would be all fine and good, if it were even a little bit true.

CanaRx is contracted by self-insured cities, schools, companies, and other
organizations to fill the prescriptions of municipal retirees and employees
at licensed pharmacies in Canada, Australia, and the UK. No counterfeit
drugs have been discovered, and there is no evidence that the medicines are
coming from any other country than those mentioned by CanaRx. The company
has helped save American taxpayers and patients about $250 million over the
past 20 years. Far from being a dangerous fraud, CanaRx is actually a
perfect example of how we can make saving money on personal drug
importation safe.

They’re also not even an online pharmacy. CanaRx and the websites they work
with are only available to participants in the program. In contrast,
international online pharmacies are available to the general public. While
many online pharmacies are rogue sites, others are very safe, like the ones
my company verifies. Just ask Roger Bate
<https://www.nytimes.com/2012/04/23/opinion/the-wrong-way-to-stop-fake-drugs.html>,
an economist and expert on counterfeit drugs from the American Enterprise
Institute: His peer-reviewed research and testing over the last 10 years
show that properly-verified international online pharmacies are just as
safe as pharmacies in the US.

This reality foils the FDA’s public stance on the issue of online
pharmacies, and it should not be used to blemish non-online pharmacy
options, like CanaRx’s program. The evidence shows that its services are
successful at keeping pharmaceutical costs down, safely. In fact, that’s
probably why the Pharmaceutical Researchers and Manufacturers of America
(PhRMA), the pharmaceutical industry’s trade group, applauded the FDA’s
efforts
<https://khn.org/news/cities-and-counties-unlikely-to-heed-fda-warning-on-importing-foreign-drugs/>
to crack down on CanaRx.

The FDA needs to properly inform—not mislead—Congress about how and why our
taxpayer money is being spent on investigations related to prescription
drug importation, especially when these investigations serve mainly to
protect one industry’s profits at the expense of tens of millions of
Americans who cannot afford their medication.

Let’s be perfectly clear: programs like CanaRx and safe personal drug
importation, generally, whether on- or off-line, are vital for American
patients who need access to the much lower prices from pharmacies in other
countries. For example, the drug Januvia, which treats type 2 diabetes,
costs about $1,700 for a 3-month supply at chain pharmacies in the US.
Januvia is manufactured by the drug company Merck in the UK. A 3-month
supply of the exact same drug can be purchased online from a UK pharmacy
for just $275. The reason that’s the case is because our system is broken.

Instead of trying to stop safe personal medicine imports, let’s reduce the
demand for them by substantially lowering drug prices here. My
organization, Prescription Justice <http://www.prescriptionjustice.org>,
supports ending the ban on Medicare drug price negotiations, stopping
patent games that prevent lower-cost generics from coming to market, and
removing giveaways to drug companies from trade agreements, like the
revised NAFTA fiasco, that seek to extend the pharmaceutical industry’s
monopoly pricing on expensive biologic drugs. We also support legislation
to officially legalize importation of lower-cost prescription drugs—but
lowering prices here would mitigate the need for such importation.

Until we actually lower prices in the US, the FDA should not aggravate the
crisis of high drug prices in America by trying to shut down CanaRx or
other avenues of safe personal drug importation. That would just be
protecting Big Pharma’s profits, not patients


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