[Ip-health] PharmacyChecker Public Comments to HHS on Lowering OOP Costs

Gabriel Levitt gabriel.levitt at gmail.com
Tue Jul 17 13:29:19 PDT 2018


*https://cdn.pharmacychecker.com/pdf/public-comment-hhs-july-2018.pdf
<https://cdn.pharmacychecker.com/pdf/public-comment-hhs-july-2018.pdf> *


*PharmacyChecker.com Public Comments to the Department of Health and Human
Services Request for Comments on How to Lower Drug Prices and Out-of-Pocket
Costs *



*Agencies: *Department of Health and Human Services and the U.S. Food and
Drug Administration


*Document Number: *2018-10435

*Author*: Gabriel Levitt, President, PharmacyChecker.com, LLC

*Contact*: gabriel.levitt at pharmacychecker.com, (718) 387-4526

*Date*: July 13th, 2018

*Introduction*

Launched in 2003, PharmacyChecker.com evaluates online pharmacies; provides
online pharmacy drug price comparisons and local U.S. pharmacy price
comparisons in conjunction with a discount card; and advocates for
expanding access, online and off, to safe and affordable imported
medicines. We are a stakeholder in the online business community seeking an
open Internet environment that promotes innovation and new business models
that serve the public health.

PharmacyChecker.com is a proud American company based in New York. We
appreciate the opportunity to submit recommendations on how to immediately
safeguard and expand access to lower-cost medicines in order to help U.S.
citizens and all people living in the U.S. reduce their out-of-pocket
prescription drug costs.

The key point made herein is that Americans already lower their
out-of-pocket costs by purchasing medicines internationally, ones that are
imported from pharmacies to fill their prescriptions. The practice is
technically restricted under federal law, but no one is prosecuted for
doing so. Wrongly, this practice has recently been curtailed and threatened
by overzealous enforcement actions by the FDA.

Tens of millions of Americans don’t fill prescriptions due to cost, making
it clear that safe international purchases of affordable medicines are a
lifeline. The FDA, however, never focuses on or recognizes the very real
and provable public health benefits of safe personal drug importation,
instead choosing to highlight the problems of rogue online pharmacies and
the dangers of importing unsafe or counterfeit medicines. *It’s possible to
do both*: guide patients who choose to import to the safest international
options and also warn against rogue sites and take enforcement actions
against them.

Despite the de facto decriminalization of personal drug importation for
individual patients, the FDA provides a blanket warning on its website and
media relations against the practice by informing Americans that
importation is inherently dangerous. The FDA sometimes prevents
lawfully-manufactured medicines, imported from licensed pharmacies, from
reaching the patients who ordered them by holding the medicines at
international mail facilities, sending them back to the pharmacy or
destroying them. The FDA also appears to be ramping up a crackdown against
safe personal drug importation that started during the Obama
administration. Current efforts are often under the guise of stopping
illegal opioid sales both online and through importation. The Secretary
should end these efforts.

*PharmacyChecker.com does not sell or facilitate the sale of
medication. *Medications
are not purchased on our site, and we have no role in the processing of
prescription orders. We verify pharmacy credentials and publish information
about online pharmacies and drug prices. That information is globally
accessible on the Internet.

Online pharmacies verified in the PharmacyChecker Verification Program meet
critical licensure, medicine quality, prescription, transparency, and
security requirements that safeguard the health of their customers. Our
focus is on the verification of international online pharmacies, websites
that process orders for prescription medicines, which are filled
internationally by mail order.

Our company’s key managers founded a non-profit organization called
Prescription Justice, which advocates for legislative regulatory reforms
including those which would 1) end the ban on Medicare negotiating drug
prices; 2) ban reverse payment schemes, also known as “pay-for-delay,”
between pharmaceutical companies that delay entry of lower-cost generics;
3) legalize the wholesale and personal importation of lower-cost medicines;
and 4) immediately expressly permit individuals to import prescription
medicines for their own use, such as those ordered online from
properly-credentialed international online pharmacies. Although we fully
support policies to lower medicine prices here, which would make personal
drug importation far less necessary, these comments are dedicated to
Prescription Justice’s fourth policy recommendation.

*Recommendations *

·        Under Section 804 (j) of the Food, Drug and Cosmetic Act, the
Secretary of Health and Human Services should expressly permit medicine
imports for personal use to empower patients seeking affordable medication.


·        Per the above, implement the Australian model of making personal
drug importation legal with caveats to prohibit personal use imports of
controlled drugs, especially prescription narcotics.

·        The FDA should end its blanket warning against ordering medicines
online, imported for personal use from pharmacies in Canada and other
countries, and instead provide guidance on best practices for those who
choose to import.

·        The FDA should stop seizing personal imports of non-controlled
medicines arriving from pharmacies that the FDA knows are licensed and
require valid prescriptions.

·        The FDA should take no enforcement actions against international
online pharmacies that it has reason to believe are the safest
international options available to Americans and instead focus on those
that represent the gravest threats, particularly ones that sell
prescription narcotics.

*Public Health Benefits of Personal Drug Importation and Online Pharmacies*

High drug prices prevent patients from taking medicines they need to get
better, stay healthy, or, in some cases, live.[1] <#_edn1> Since the
beginning of this millennium, Americans have successfully used the Internet
to buy lower-cost medicines, ones imported for personal use from licensed
pharmacies in Canada and other countries, while the FDA and pharmaceutical
companies have pushed back.[2] <#_edn2> According to one survey by the
Kaiser Family Foundation, about eight percent of Americans (almost 20
million people), say that they have imported medicines due to cost.[3]
<#_edn3>

The same medicines sold domestically are often 80% less in other countries.
[4] <#_edn4> In Canada specifically, commonly-prescribed, brand-name
medicines cost about 70% less than in the U.S.[5] <#_edn5> About 45 million
Americans did not fill a prescription in 2016 due to cost.[6] <#_edn6>
Lower prices at pharmacies outside the U.S. can help millions receive
treatments that are otherwise out of reach: a clear benefit to public
health.

*FDA Consumer Education and Enforcement Discretion *

The U.S. Food and Drug Administration is known for using its enforcement
discretion to allow personal imports of medicines in some cases.[7] <#_edn7>
Most notable is the fact that no one has ever been prosecuted for illegally
importing a non-controlled medicine for personal use.[8] <#_edn8>

Despite this, the FDA provides a blanket warning to consumers against all
international purchases of lower-cost medicines over the Internet.[9]
<#_edn9> In doing so, the FDA wrongfully ignores the public health benefits
of personal drug importation and potentially scares people away from
medicine they can afford.[10] <#_edn10> This is entirely unnecessary and
unfair to uninsured and under-insured Americans.

As recently reported by the non-profit media organization, Tarbell,
cooperation between the FDA and the pharmaceutical industry that began
during the Obama administration has led to measures imposed on Internet
companies that curtail access to safe, international online pharmacies.[11]
<#_edn11>

Recently, under the Trump administration, the FDA Office of Criminal
Investigations has raided offices in Florida that help Americans safely
navigate the Internet to purchase lower-cost medicines. The agency has even
increased seizures of medicines ordered by people with valid prescriptions.
[12] <#_edn12>

Accessing legitimate, lower-cost medicines for personal import means
immediate relief from high drug costs for those that have no other choice.
At a maximum, the FDA should be transparent about this lifeline of
affordable medicines and help Americans find the safest international
options. At a minimum, the FDA should stop 1) seizing medicines they know
are coming from licensed pharmacies by refusing the import; or 2) using the
opioid crisis as a pretense to crackdown on Internet sales of
non-controlled medicines dispensed by licensed pharmacies that require
valid prescriptions.

*The Secretary of Health and Human Services Has the Authority to Expressly
Permit Personal Drug Importation*

The wholesale importation of medicines that are not FDA-approved is against
the law, but there are clear statutory allowances to expressly permit
personal drug importation.

Short of legalization, Section 804 (j) of the Food, Drug and Cosmetic Act,
empowers the Secretary of Health and Human Services to *permit* personal
drug importation by setting policies for enforcement discretion by the FDA.
[13] <#_edn13> A report published by Prescription Justice
<http://prescriptionjustice.org/PJ_recommendations_for_Trump_on_drug_prices.pdf>
shows exactly how and why this can be done in Appendix A <#Appendix_A>:

Section 804 (J) allows for the creation of regulations to achieve the
public health benefit of personal drug importation and allows the access to
extend beyond Canada. Short of *legalization*, the Secretary is empowered
to create guidelines for *enforcement discretion* to expressly permit
importation by individuals “by regulation or on a case-by-case basis.” The
law states that the Secretary can “exercise discretion to *permit* individuals
to make such importations in circumstances in which…the importation is
clearly for personal use…and the prescription drug or device imported does
not appear to present an unreasonable risk to the individual.”
Lawfully-manufactured
medications from Canada and many other countries do not present an
unreasonable risk to individuals who import them.[14] <#_edn14>

The Secretary should exercise this authority by instructing the FDA to end
its blanket warning against safe personal drug importation; identifying the
safest international online pharmacy options; ceasing seizure of imports of
non-controlled medicines for personal use known to be purchased by licensed
pharmacies that require valid prescriptions; and ending enforcement threats
against the safest international online pharmacies.

*The PharmacyChecker Verification Program*

Online pharmacies, including those based outside the U.S., that meet the
requisite pharmacy standards of practice can apply to the PharmacyChecker
Verification Program (the “Program”). The pharmacy standards and policies
are public:
https://www.pharmacychecker.com/pdf/membership_standards_and_guide_rev_4.16.18.pdf
.

Applicants must meet the following standards of practice to be eligible for
the Program.

*1.       **Valid prescription requirement*- The online pharmacy must
require a valid prescription and its website must clearly display this
requirement.

*2.      **Controlled Substances* *Restricted* - Controlled substances, as
defined by the U.S. Drug Enforcement Agency (DEA), may only be marketed,
sold, processed and/or dispensed by pharmacies that are properly registered
with the DEA. The online pharmacy must meet all the requirements of the
Ryan Haight Online Pharmacy Consumer Protection Act of 2008.

*3.       **Information Security* - The online pharmacy’s website must
employ Secure-Socket Layer or equivalent technology to ensure protection of
health and financial information of consumers.

*4.       *Co*untry Transparency *- The online pharmacy’s website must
disclose to consumers the specific country or, if applicable, the list of
potential countries from which a drug will be dispensed.

*5.       **Customer Service for consumers *- The online pharmacy’s website
must clearly publish a telephone number that allows consumers to reach the
pharmacy staff for customer service.

*6.      **Pharmacist Consultations* - The online pharmacy’s website must
conspicuously publish that pharmacist consultation with a licensed
pharmacist is available for patients who have questions about their
medications.

*7.       **Pharmacy / Pharmacist Licensure* - All transactions processed
through the online pharmacy’s website must be directly confirmed, dispensed
and shipped by a licensed pharmacy that is also verified by
PharmacyChecker. Medication
orders must only be dispensed by a pharmacist licensed in the pharmacy’s
jurisdiction.

*8.       **Marketing Claims* - The online pharmacy’s website must only
make claims that are truthful and/or not misleading to the consumer, e.g.
claims about generic medications may not refer to generic medications as
“the same as” or “identical to” their brand-name counterparts.

Verified pharmacies must adhere to laws in the countries where they operate
in addition to PharmacyChecker standards. Verified online pharmacies are
authorized to publish the PharmacyChecker Seal, which links to its pharmacy
profile hosted on www.PharmacyChecker.com. By clicking on the seal, people
can verify the approved status of the online pharmacy.

PharmacyChecker staff monitor compliance utilizing various audit
techniques, such as mystery shopping, remote monitoring of websites, as
well as inspections performed by PharmacyChecker staff.

Pharmacies found to be out-of-compliance are subject to penalties up to and
including termination from the Program. As a private verification firm,
that is the extent to which we can sanction a pharmacy.

The PharmacyChecker Verification Program is managed by Shivam Patel,
PharmD, a licensed pharmacist in Massachusetts. His predecessor and former
mentor, Kelly Ann Barnes, JD, Rph, was Vice President of Pharmacy
Verification and Information from 2016-2018, during which time our company
further developed and enhanced its pharmacy standards and policies. Ms.
Barnes came to PharmacyChecker from the Massachusetts Board of Registration
in Pharmacy where she held the title of Director of Pharmacy Quality
Assurance.

*Online Drug Price Comparisons *

Many online pharmacies in the Program list their pharmacy and drug prices
on www.PharmacyChecker.com. This information is freely available to the
public. Patients can compare prices on medicines and find safe
international online pharmacies that enable them to import safe and
effective medicines they can afford.

Recently, PharmacyChecker conducted an analysis of medicines identified in
a report published by the Senate Homeland Security and Governmental Affairs
Committee as the most commonly prescribed medicines through Medicare Part D
in 2015. In the U.S., those products increased in price by 12% annually
between 2012-2017. PharmacyChecker’s analysis showed that the lowest prices
available internationally were 80% less than average U.S. pharmacy prices.
[15] <#_edn15>

*Peer-Reviewed Research of PharmacyChecker-Verified Online Pharmacies*

Peer-reviewed research has proven that patients who order from
PharmacyChecker-verified international online pharmacies import and receive
lawfully-manufactured, safe and effective medicines at much lower prices
than available in the U.S.[16] <#_edn16> The research was led by Roger
Bate, who is affiliated with the American Enterprise Institute, a think
tank and policy organization with which FDA Commissioner Scott Gottlieb,
MD, was also affiliated before his appointment to the FDA.

>From 2008 to 2016, 822 online medication orders were tested: 275
medications from 22 international online pharmacies verified by
PharmacyChecker.com (12 of which are also verified by the Canadian
International Pharmacy Association); 127 medications from eight U.S.-only
online pharmacies verified by the National Association of Boards of
Pharmacy and/or LegitScript.com; and the rest from websites with no
verification. Brand-name medicines were tested using a Raman Spectrometer
and by authenticating the products with pharmaceutical companies. Generic
medicines were tested using the Global Pharma Health Fund (GPHF) e.V.
Minilab®.[17] <#_edn17>

*Verified U.S. pharmacies sold* *zero counterfeits* but one (out of 127)
order of generic Cipro was slightly substandard.

*Verified international pharmacies sold zero counterfeits* but one (out of
275) order of generic Cipro was slightly substandard.[18] <#_edn18>

It’s important to note that the one substandard medicine was available for
sale at brick and mortar pharmacies in the U.S., not just at online
pharmacies.[19] <#_edn19>

In contrast, online pharmacies with *no verification* sold eight
counterfeits and 16 substandard drugs (out of 332 tested).

*Overall, the peer-reviewed research found that the
PharmacyChecker-verified pharmacies sold medicines of equal quality to the
U.S. pharmacies and required valid prescriptions.*

Encouraging patients to access to these verified international online
pharmacies and steering them away from rogue websites help people obtain
prescribed medicines at affordable prices and protect them from falsified
and substandard products.

*The Australian Model of Patient Empowerment and Freedom *

In Australia, people are expressly permitted to import small quantities of
prescription medicines for family members or their own use – not for
resale. Imports must be limited to a three-month supply per order, and, for
certain medicines, a prescription is needed by the individual importer.[20]
<#_edn20> Medicines containing a controlled substance, such as prescription
narcotics, are not permitted for import.[21] <#_edn21>

The Australian model, under the authority of the Therapeutic Goods
Administration, respects the integrity and intelligence of its citizens to
make their own healthcare decisions. The TGA clearly communicates this
policy on its website, with warnings about ordering medicines over the
Internet.[22] <#_edn22> Under the authority of the Secretary, the FDA
should implement a similar protocol to permit personal importation. The
FDA’s website and patient communications should end the blanket warning
against purchasing medicines over the Internet from sites that offer lower
prices than available in the U.S.

*Conclusions*

Personal importation of lower-cost medicines helps millions of Americans
each year lower their out-of-pocket costs. The Secretary should grant the
FDA the authority to guide patients to the safest international online
pharmacy options, while continuing to crack down on rogue pharmacy sites
and illegal online opioid sales and imports

The work of PharmacyChecker is a useful model for providing people with the
information they need to find the lowest prices from licensed international
pharmacies and to avoid rogue sites.

Pretending safe personal drug importation does not exist simply exacerbates
the problems of high out-of-pocket costs, cost-related non-adherence, and
diminishing faith in government agencies with ties to the pharmaceutical
industry.



Appendix A




*How the Trump Administration Can Rapidly Lower Drug Costs for Americans*
Executive actions that can ease the drug affordability crisis
using online pharmacies and personal drug importation

January 2017

The new administration can rapidly lower drug costs for Americans at no
cost to the government and without legislative reform. Prescription Justice
developed a framework and recommendations designed to provide immediate
relief from high drug prices by expressly permitting consumers to import
lower cost medication for personal use from safe international online
pharmacies. In many cases, prescription drugs can be purchased from safe
non-U.S. pharmacies for 10% of their cost in the United States.[23]
<#_edn23>

Despite federal restrictions, tens of millions of Americans have purchased
medication from other countries, including over the Internet, to find lower
cost medication from Canada and other countries. For many of them, safe
international online pharmacies are a lifeline for affordable medication,
but there are also rogue pharmacy websites, which are a threat to
consumers. Executive actions can help Americans reach the latter but avoid
the former.

At a time when Americans are looking for decisive action to bring down
their healthcare costs, giving them a choice in how to manage their
prescription drug purchases will put more money into their pockets and
reduce the number of patients, currently about 45 million, who go without
needed medications due to cost.

*Principles and Policies for Executive Action*

·        Consumers should have access to the widest possible choices online
to access safe and affordable medication.

·        Drug safety is inextricably linked to the issue of price because
an unaffordable medication is neither safe nor effective. Therefore, the
safest online sources for affordable medication save American consumers
from forgoing prescribed medication.

·        Government should promote a competitive online marketplace for
safe pharmaceuticals, one that respects and empowers consumers and the
public health necessity of access to lower prices.

·        Laws, regulations, and enforcement actions that impede online
access to lower-priced, personally imported medication are inimical to good
public health and economic fairness.

·        Federal policies that affect online access to medication should be
consumer-focused, patient-centered, evidence-based, and created within the
context of a health crisis caused by high drug prices in America.

·        Federal enforcement efforts to curtail the online sale of
counterfeit and substandard medication should give priority to the
dangerous, illegally operating online pharmacies and recognize the public
benefit of the safest international online pharmacies.

·        Federal agencies should not knowingly curtail access to safe
international online pharmacies and should use the utmost discretion to
avoid doing so through their enforcement efforts to combat rogue sites and
counterfeit drugs.



*Background/Rationale*

*The Drug Affordability Crisis*

Prescription drug costs comprise an increasing percentage of federal,
state, and municipal budgets each year, but the crisis hits home hardest
where out-of-pocket drug costs are too high. Every day, thousands of
Americans are faced with having to pay for expensive medications and the
realization they cannot.  The Commonwealth Fund estimates that 45 million
Americans did not fill a prescription in 2016 due to cost.[24] <#_edn24> A
survey by the Harvard School of Public Health indicates that over 50
percent of people who don’t take prescribed medication due to cost are
getting sicker.[25] <#_edn25> That’s potentially 22.5 million Americans
whose health suffers because of high drug prices, in addition to the
countless millions who can manage to pay unreasonable prices but would
benefit from lower ones.

According to the National Consumers League and the Food and Drug
Administration (FDA), 125,000 deaths are caused by prescription
non-adherence (failure to take prescribed medication as directed) each year.
[26] <#_edn26> Not all are the result of cost factors but a survey of CVS
pharmacists, in which 62 percent of 2,400 retail pharmacists reported cost
as the number one reason patients aren’t taking their medications,[27]
<#_edn27> makes it clear that high drug prices significantly contribute to
people dying.

There’s a public consensus that the price of prescription medication in the
United States is unreasonable.[28] <#_edn28> The nearly 30 million
uninsured Americans and tens of millions of underinsured Americans, ones
who don’t have adequate coverage for prescriptions, are facing stark
choices because of drug prices.[29] <#_edn29> Over 10 million households
have had to choose between food and medication. [30] <#_edn30>

Americans with cancer are two and half times more likely to declare
bankruptcy; and those that do declare bankruptcy are 80 percent more likely
to die from their illness.[31] <#_edn31>  New medications exist to treat
Hepatitis C, an infection of the liver which lead to 19,659 deaths in 2014,
but they are so expensive that private and government insurance programs
usually do not cover them except for patients who become very ill. For the
uninsured, these medications, priced at close to $100,000 for a three-month
treatment are entirely out of reach.  While Cancer and Hepatitis C
medications are far more expensive than treatments for most conditions,
Americans with common conditions, such as asthma, depression, diabetes, and
heart disease, are too often ending up in the hospital because they can’t
afford their prescriptions.[32] <#_edn32>

*Importation and Online Pharmacies: A Lifeline of Affordable Medication *

During his campaign, Mr. Trump supported allowing Americans to import lower
cost medications.[33] <#_edn33> Thirty-three members of Congress have
recommended executive action to immediately assist Americans by exploring
new rules affecting prescription drug importation that are already
permitted under U.S. law.[34] <#_edn34> Current law gives the Secretary of
Health and Human Services the authority to revise regulations on
enforcement discretion to permit safe personal drug importation.  As part
of that action, it’s critical to understand that safe personal drug
importation through properly verified online pharmacies is already a
lifeline of affordable medication.[35] <#_edn35> Actions to expand this
lifeline will benefit the public’s health.

Patented drugs, on average, cost less than half in member countries of the
Organization for Economic Cooperation and Development (OECD) than in the
U.S.[36] <#_edn36> The world’s top selling 20 medications are three times
more expensive in the U.S. than in the U.K.[37] <#_edn37> It is common for
brand name drugs to be as much as 90 percent lower from pharmacies outside
the U.S. purchased online.[38] <#_edn38> Here are some examples:


*Brand Drug Price Comparison U.S. vs. Canada and other International Prices*

*Drug*

*U.S. Price1*

*Canadian Price2 / *

*(Savings)*

*International Price3 / *

*(Savings)*

*Advair Diskus*

Asthma and COPD

$978



$341 (65%)



$99 (90%)



*Zetia*4

High Cholesterol

$836

$227 (73%)



$156 (81%)



*Januvia*

Type-2 Diabetes

$1,061



$351 (67%)



$91 (91%)



*Daraprim*

Toxoplasmosis

$4,604



N/A

$97 (98%)



*Epipen Autoinjector*

Severe allergic reactions

$631



$225 (64%)



$172 (73%)



(Prices based on a 90-day supply of the medication collected in September
2016)

1 Based on the Lowest Price in New York found on GoodRx.com.

2 Prices at Canadian pharmacies available online at Pharmacies verified by
PharmacyChecker.com.

3 Lowest international prices found on PharmacyChecker.com drug price
comparisons.

4 Marketed as Ezetrol in Canada and other countries internationally.





Despite federal restrictions, each year about four million Americans
personally import medication due to cost.[39] <#_edn39> For some, it’s
their only option.[40] <#_edn40> Many of them do so by placing orders with
online pharmacies that process prescription orders, which are then shipped
from pharmacies outside the U.S.[41] <#_edn41> When done safely, this is a
boon to public health as it enables Americans to afford medications filled
by licensed pharmacies that require valid prescriptions written by U.S.
prescribers.[42] <#_edn42>

Legitimate public health concerns about rogue online pharmacies and
counterfeit drugs are being misused by the pharmaceutical industry to
encourage legislative, regulatory, and private sector actions that curtail
access to licensed pharmacies providing safe and affordable medication.[43]
<#_edn43> With proper guidance, American consumers can be protected from
dangerous websites and medicines without being deprived of online access to
safe and affordable medication.[44] <#_edn44>



*Federal Law, Regulation, and Practice*

In policy debates about *legalizing* drug importation, the reality of
international trade in pharmaceuticals becomes obscured. Drug importation
is already legal and imported pharmaceuticals comprise a large share of
domestically dispensed medications. According to the FDA, 80 percent of
active pharmaceutical ingredients and 40 percent of finished FDA-approved
drugs, the ones sold in U.S. pharmacies, were made in other countries.[45]
<#_edn45>  The relevant questions are: which drugs can be imported, who can
and cannot do the importing, and who *should* be able to?

Individuals are not technically banned from importing a prescription drug
for their own use, unless it’s a drug manufactured domestically. However,
in contrast to commercial importation, there are three reasons why it is,
under most circumstances, unlawful to import medication for personal use:

1.       *Reimportation*, meaning medications made domestically, exported,
and then imported back, is expressly banned except by the manufacturer.

2.       Imported medications manufactured in FDA-registered
establishments, ones which would be identical in their composition to those
sold in a U.S. pharmacy, are packaged and labeled differently for foreign
markets and pharmacies and, therefore, considered *misbranded*.

3.       Lawfully-manufactured imported medications that are foreign
versions of FDA-approved drugs (and therefore *not* “FDA-approved”) are not
necessarily made in accordance with FDA manufacturing standards and,
therefore, are designated by FDA as *unapproved*. For example, Daraprim,
made by GlaxoSmithKline in Germany and sold in the UK, is considered an
*unapproved* drug by the FDA. The FDA-approved Daraprim, licensed to Turing
Pharmaceutical, is made by a contract manufacturer in North Carolina.



*Though usually technically illegal, and always discouraged by the FDA,
personal importation appears to be generally permitted.*

·        The FDA’s published guidance allows its personnel to use
discretion to allow personal imports of medications that have yet to be
approved for sale in the U.S.

·        Medications intended for personal use almost always reach the
patient.

·        Since individuals are not prosecuted for importing small
quantities of medications for their own use, the practice is *de facto
*decriminalized.


·        Since many personally imported medications are the exact same
drugs sold in local pharmacies (meaning ones produced under FDA’s exact
safety protocols), importers (consumers) could potentially overcome
misbranding designations if they properly challenge the FDA for refusing
their imports.



The FDA is permitted to destroy personally imported medication, even those
that are lawfully manufactured and made in FDA-registered facilities.[46]
<#_edn46> Section 708 of the Food and Drug Administration Safety and
Modernization Act of 2012 amended the Food, Drug and Cosmetic Act (FDCA) to
permit the FDA to destroy imported medication valued at $2,500 or less, but
only after creating regulations providing the importer with due process to
defend the import.[47] <#_edn47> The final rule was adopted in August 2015.
To date, the new law has not been used to widely stop the safe importation
of medication for personal use. Consumers, however, are fearful of that
potential.[48] <#_edn48> Several members of Congress have publicized
concerns about this provision of law as detrimental to patients seeking
lower cost medications.[49] <#_edn49>

*Flexibilities in the law allow for more consumer choice*

Section 804 of the Food, Drug, and Cosmetic Act allows for new regulations
to expand and encourage the importation of lower cost medications,
including and specifically for personal use. Section 804 of the FDCA makes
it legal to import medication from Canada, both commercial and personal
quantities.[50] <#_edn50> That express legality is relegated only to
importation from Canada and *only* if the Secretary of Health and Human
Services certifies the safety of such importation poses “no additional risk
to the public’s health and safety.”[51] <#_edn51> However, it is
unrealistic to provide such certification because it is virtually
impossible to meet the bar of “no additional risk” to the public’s health:
any regulatory change that expands access to even one new medication
carries *some* additional risk, even if the added risk is far outweighed by
the benefits.

Lawful drug importation already occurs (even without activating Section 804
provisions) from Canada but only through distribution channels controlled
by pharmaceutical companies, which means the same drugs sold in Canada are
priced much higher in the U.S. Section 804 changes the rules of
distribution to benefit consumers who would have lawful access to the lower
prices charged in Canada, and other countries as explained below.

Section 804 (J) allows for the creation of regulations to achieve the
public health benefit of personal drug importation and allows the access to
extend beyond Canada. Short of *legalization*, the Secretary is empowered
to create guidelines for *enforcement discretion* to expressly permit
importation by individuals “by regulation or on a case-by-case basis.” The
law states that the Secretary can “exercise discretion to *permit* individuals
to make such importations in circumstances in which…the importation is
clearly for personal use…and the prescription drug or device imported does
not appear to present an unreasonable risk to the individual.”
Lawfully-manufactured
medications from Canada and many other countries do not present an
unreasonable risk to individuals who import them.[52] <#_edn52>

*Examples of Federal Actions that Curtail Online Access to Safe Personal
Drug Importation *

Unfortunately, Federal actions both past and present are impairing the
ability of Americans to buy lower cost medication from other countries,
contrary to what is technically permissible under law and what is fair to
cash-strapped Americans, 30 million of whom lack health insurance. Such
actions do not protect but hurt consumers and should not continue.

Most notably, the White House Office of the Intellectual Property
Enforcement Coordinator caused the formation of the Center for Safe
Internet Pharmacies (CSIP) in 2010, through which gatekeepers to Internet
commerce are asked to voluntarily refuse service to safe international
online pharmacies that sell lawfully manufactured medication pursuant to a
prescription.[53] <#_edn53> CSIP members include search engines, credit
card companies, domain registrars and private mail carriers. Their efforts
are misleadingly publicized as targeting only rogue online pharmacies that
sell counterfeit drugs, fill orders from unlicensed sources, or don’t
require a prescription. However, they ensnare the safest international
online pharmacy options as well.[54] <#_edn54>

Search engines, for example, are effectively prevented under the threat of
prosecution from allowing Canadian pharmacies to advertise to Americans –
even though such advertising is not prima facia illegal.[55] <#_edn55> A
well-publicized non-prosecution agreement between the U.S. and Google did
not establish that it was illegal for Google to allow ads for licensed
pharmacies in Canada.[56] <#_edn56> It did show that Google flouted its own
internal rules on blocking ads that enabled rogue online pharmacies to
advertise the sale of controlled drugs without a prescription, which was
then used as justification to force Google to agree to stop ads from safe
international online pharmacies.[57] <#_edn57>

In Bing’s search results, a click on online pharmacies that the FDA has
identified as “fake” results in a warning that reads: “The FDA has issued a
Warning Letter related to this site, and it may offer drugs that are
unsafe.” The FDA’s list of websites that have received warnings are
referred to as “fake online pharmacies” – a group that includes some real
online pharmacies that meet the highest standards of international online
pharmacy practice. For example, one of the companies on the FDA’s list is a
licensed brick and mortar pharmacy in Canada. This policy may lead
consumers to forgo a safe international online pharmacy due to the pop-up
warning but then end up choosing a rogue site as they continue to search
for affordable medication. Under Bing’s policy, consumers can be scared
away from lower cost medication, which is bad for their health and savings,
and more likely to choose a rogue site and end up with a counterfeit drug.
[58] <#_edn58>

Through membership in CSIP, credit card companies VISA and MasterCard have
adopted policies prohibiting the use of credit cards by consumers on
websites in which a person buys a medication that is imported for personal
use into the U.S. Americans, therefore, must often pay by check.[59]
<#_edn59>

The strategic conceptualization and plan to pressure the Internet ecosystem
of businesses to curtail access to all international online pharmacies was
articulated in the 2010 public comments of an organization started by Eli
Lilly, the National Association of Chain Drugstores and LegitScript, called
Alliance for Safe Online Pharmacies (Alliance).[60] <#_edn60> The Alliance
and LegitScript are ex-officio members of CSIP. Their combined efforts with
the federal government are viewed as censorship by respected Internet free
speech organizations and publications.[61] <#_edn61>, [62] <#_edn62>

The FDA’s public education campaigns wrongly provide a blanket warning
against buying a medication online from outside the U.S.[63] <#_edn63> Due
to the real online dangers that exist, the agency’s warnings about the
threats posed by dangerous online pharmacies are helpful but some of its
assertions contradict the facts about buying medication online, and
inadvertently prevent Americans from finding affordable and safe
medication. FDA’s communications with Congress have also conflated
illegally imported but lawfully-manufactured medications with counterfeit
drugs, equating the two as equally dangerous.[64] <#_edn64>

These actions by the federal government and private companies are
overreaching, unnecessary and unfair to consumers.  Executive actions
designed to allow consumers the ability to access safe international
pharmacies while warning them of the risks of rogue sites are sensible and
achievable.  A blanket policy that wraps all online pharmacies together is
simply undermining public health, as well as trust in government, and works
as a disservice to Americans looking for affordable medication.

*Recommendations for Executive Action*

·        Pursuant to Section 804 (J) of the Food, Drug and Cosmetic Act
(FDCA), enact regulations that would permit individuals who have a valid
prescription to import non-controlled prescription medication for their own
use, not to exceed a three-month supply. A fitting model for regulations is
offered by Australia’s law on personal drug importation, a country in which
personal imports are expressly legal.[65] <#_edn65> The key elements of
Australia’s law (as would apply to U.S. application) reflect commonsense
respect for consumer choice:



o   Imported medications are for personal use or an immediate family
member;

o   If the medication requires a prescription in the U.S., the importer
must have a prescription from a U.S. provider;

o   Imported medications for personal use may not include controlled
substances, as defined under U.S. law (such as Vicodin, Adderall, or
valium); and

o   The total quantity of the imported medications within a 12-month period
does not exceed 15 months’ supply (at the maximum dose recommended by the
manufacturer).



·        Revise FDA’s website’s consumer information to:



o   Warn consumers about rogue online pharmacies, but *no longer provide a
blanket warning against purchasing medication internationally.*

o   Use a definition of “rogue online pharmacies” or “fake online
pharmacies” that reflects a rational, consumer-focused, patient-centered,
and evidence-based analysis of online pharmacies, one that focuses strictly
on public health considerations, rather than technical restrictions on
personal drug importation and intellectual property law.

o   Accurately communicate the benefits and risks of ordering from
international online pharmacies.



·        Redirect federal enforcement initiatives that target the
“chokepoints” of the Internet ecosystem (e.g., registrars, registries, mail
carriers, payment processors, credit card companies, search engines) so
that they do not curtail online access to medication from safe online
pharmacies and, instead, focus exclusively on rogue online pharmacies.



·        Refrain from enforcement actions against the safest international
online pharmacies. For example, the FDA has cited the existence of about
34,000 rogue active Internet pharmacies.[66] <#_edn66> There are 55
international online pharmacies vetted by credentialing and price
comparison company PharmacyChecker.com.[67] <#_edn67> Those international
online pharmacies are known to meet stringent safety criteria among
websites selling to consumers in the U.S. for personal import and should
remain as safe options for Americans who need them.[68] <#_edn68> There are
tens of thousands of rogue and dangerous medication-selling websites to
investigate and take legal action against to protect consumers.



·        Develop clear guidelines for FDA enforcement discretion to
minimize refusals and destructions of lawfully manufactured, genuine
medication imports held at international mail facilities. Failing to do so
will mean patients will not receive appropriate medications they have
ordered.



*Conclusion*

These recommendations for executive action on personal drug importation and
online pharmacies will not solve the crisis of high drug prices in America
but will give more Americans immediate and necessary relief from staggering
drug costs.

The past 15 years in which Americans have purchased lower cost medication
online for personal import has served as a live pilot project. During that
time, the FDA has never reported a death or serious adverse reaction by an
American who ordered medication from an international online pharmacy that
required a valid prescription. But the practice is still discouraged and
made more difficult by federal regulators.

These recommendations are meant to buttress, not undermine the role of the
FDA. Prescription Justice respects the FDA’s critical role in safeguarding
our nation’s drug supply, but we urge the agency and other relevant federal
and state agencies to use the widest possible discretion so that their
actions against unsafe and counterfeit drugs and rogue online pharmacies do
not impede access to safe personal drug importation from *safe*
international online pharmacies. At a minimum, the FDA needs to provide the
facts in an objective manner about buying medication online.

Until we pass sensible legislation to make personal importation of lower
cost medication expressly legal, and, more importantly, bring down drug
prices in the U.S., expressly permitting safe importation is good for
public health and for American consumers who are struggling to purchase or
simply cannot afford their prescribed medication.

*About Prescription Justice*

Prescription Justice is a not-for-profit organization dedicated to
providing relief and protection from the soaring costs of prescription
medication for American patients. Forty-five million Americans did not fill
a prescription in 2016 due to cost. Millions must choose between food and
medicine in the world’s richest country. Forgoing prescribed medication
leads to sickness and death, and even greater healthcare costs due to
hospitalizations. Americans need justice when it comes to drug prices.



Through education, outreach and coalition building, Prescription Justice
advocates for regulatory and legislative reforms and commonsense policies
to lower domestic drug prices and expand access to lower cost medication
from pharmacies in other countries. Prescription Justice brings together
doctors, lawyers, public health advocates, and companies dedicated to
helping people afford medication. Prescription Justice received initial
funding by PharmacyChecker.com <http://www.pharmacychecker.com/>.



*Contact Information*

Jodi Dart

Executive Director

Prescription Justice

(217) 306-5823

jodi at pjag.org



*Board of Directors*

Steven Barrett, MD – Quack Watch

David Belk, MD – True Cost of Healthcare

Tod Cooperman, MD, President of ConsumerLab.com and CEO of
PharmacyChecker.com

Lee Graczyk – RxRights.org

Doug Grover, Esq. – Schlam Stone & Dolan LLP

Gabriel Levitt – President, PharmacyChecker.com

Jake Nadler – Berkshire Prescription Services







------------------------------

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[21] <#_ednref21> Ibid.

[22] <#_ednref22> Ibid.



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[28] <#_ednref28> Kaiser Health Tracking Poll: September 2016. By Ashley
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[44] <#_ednref44> Elliott a. Foote 2015, Gabriel Levitt 2015.

[45] <#_ednref45> Sklamberg, Howard and Michael Taylor, “In India, With Our
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[47] <#_ednref47> Pub. L. No. 112-144, § 708 (2012).

[48] <#_ednref48> Change.org petition.

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[51] <#_ednref51> Section 804.

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