Innovations-Magazine-August-2022 - 5

POLICY PERSPECTIVES
In March 2022, FDA presented on the SIP
proposal process to representatives from several
states, the National Academy for State Health
Policy, and HHS. Notably, FDA emphasized
that the final rule does not provide a time
frame for review and approval of an SIP, but
that the agency anticipates providing feedback
regarding an SIP proposal's adherence to the
requirements within six months of submission.
Most recently, in May 2022, FDA issued a
small entity compliance guide titled Importation
of Prescription Drugs Final Rule Questions and
Answers; Guidance for Industry that provided 12
questions and answers intended to help small
entities better understand and comply with the
final rule. This guidance document uses plain
language to restate the legal requirements set
forth in the final rule.
NABP and Protecting the US Drug
Supply Chain
Recognizing the challenges states will likely face
regarding drug importation and patient safety,
NABP has developed an initiative to further
educate the states regarding the final rule.
During her term, 2021-2022 NABP President
Caroline D. Juran, BSPharm, DPh (Hon), led
an initiative to address state prescription drug
importation programs authorized by Section
804 of the FD&C Act. The initiative focused
on three aspects of importation:
1. Providing guidance to state and federal
governments and other policymakers on
the risks associated with prescription drug
importation and the regulatory oversight
process(es) necessary to help mitigate
those risks;
2. Working with state and federal regulators to
implement DSCSA requirements, including
providing education and other tools to
regulators and supply chain participants to
assist in implementation; and
3. Educating the public about the risks
associated with purchasing prescription
drugs from unknown sources online and
through social media.
As part of the initiative, Juran established a
task force to evaluate SIPs. The task force issued
a report and developed five recommendations:
1. Assist the boards of pharmacy by
monitoring bills on prescription drug
importation and developing resources for
boards to use in educating their legislators.
2. Communicate with Canadian regulators
about importation issues, especially
wholesale distributors that sell prescription
drugs to approved state agents.
3. Discuss with Canadian regulators the
NABP programs that could assist with
regulatory oversight and be utilized for
nonresident importers within the US.
4. Develop nationwide consumer education
programs that inform patients about
their state's legal SIPs versus illegal
importation of prescription drugs.
5. Develop DSCSA educational programs
and tools for health care providers
and regulators.
The full report, detailing areas of concern
identified by the task force, is available under
Reports on the NABP website.
State Action and Ongoing Litigation
Since the passage of the final rule in 2020,
several states, including Colorado, Florida,
Maine, New Hampshire, New Mexico,
and Vermont have passed laws allowing
for the importation of drugs from Canada.
Other states, including Hawaii, Illinois,
Massachusetts, Michigan, Minnesota, New
Jersey, New York, Oklahoma, Pennsylvania,
and Rhode Island, have proposed legislation
to participate in SIPs. As of the publication
of this article, no state SIP proposal has been
authorized by FDA.
On November 23, 2020, Pharmaceutical
Research and Manufacturers of America
(PhRMA) filed a complaint against HHS
alleging that the final rule is contrary to
Section 804, is unsupported by the record,
disregards key protections of the FD&C Act
that are designed to ensure patient safety, and
provides no indication that the final rule will
reduce costs for American patients. Further,
the lawsuit alleges that aspects of the final
rule are contrary to the FD&C Act, violate
manufacturers' First Amendment rights,
and raise serious questions under the Fifth
Amendment Takings Clause. In May 2021,
HHS filed a motion to dismiss the lawsuit on
the grounds that PhRMA preemptively filed
the lawsuit (before the implementation of any
SIPs) and thus cannot establish any present
injury. Crucial to this argument is HHS'
explanation of how difficult it will be to obtain
FDA approval to import drugs from Canada.
HHS even identified that Canada's minister
of health issued an interim order prohibiting
potential Canadian distributors from
distributing drugs outside of Canada unless
they have " reasonable grounds to believe that
the distribution will not cause or exacerbate a
shortage of the drug. " According to HHS, the
Canadian interim order suggests uncertainty as
to whether the final rule will be implemented.
In October 2021, the court denied HHS'
motion to dismiss, and, as of press time, the
lawsuit is ongoing. In addition, PhRMA has
filed citizen petitions challenging the state SIP
proposals submitted to HHS by Florida and
New Mexico.
Conclusion
It remains to be seen whether the final
rule will be implemented effectively.
Recent FDA efforts to educate and engage
stakeholders, including issuing guidance
documents and conducting presentations,
as well as President Biden's executive
order, suggest that FDA is not ready to
count out drug importation as a potential
approach to lower drug prices. However,
considering that no state SIP proposal has
been authorized by FDA, the pending legal
challenges by PhRMA, and the Canadian
interim order, it is clear that several
obstacles remain to the implementation of
the final rule. Only time will tell if these
obstacles become surmountable.
This article was written by Jonathan A. Keller,
PharmD, JD, RPh, and Winnie R. McBride, JD,
with Faegre Drinker Biddle & Reath LLP. Please
note, the opinions and views expressed by Faegre
Drinker Biddle & Reath do not necessarily reflect
the official views, opinions, or policies of NABP or
any member board, unless expressly stated.
AUGUST 2022 | 3
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/importation-prescription-drugs-final-rule-questions-and-answers-small-entity-compliance-guide
Innovations-Magazine-August-2022

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