PSM presented a special webinar for families affected by counterfeits and fentanyl. Learn about opportunities to make your voice heard. You can watch the presentation at https://youtu.be/FmBv3Bb7ZHI

1. Advocacy opportunities for family
advocates on counterfeit drugs and
fentanyl
Shabbir Imber Safdar
Executive Director, PSM
Stacey Barrack
Venture Global
Lisa Hicks
Family Advocate

2. ADAP Advocacy Association
Alabama Pharmacists Association
Alaska Pharmacists Association
American Pharmacists Association
Arizona Pharmacy Alliance (AzPA)
Association for Accessible Medicines
Biotechnology Innovation Organization
Colorado Pharmacists Society
Community Access National Network
Connecticut Pharmacists Association
Delaware Pharmacists Society
Florida Pharmacy Association
Healthcare Distribution Association
HealthCare Institute of New Jersey
HealthHIV
Illinois Pharmacists Association
Indiana Pharmacists Association
Institute for Safe Medication Practices
International AntiCounterfeiting Coalition
International Health Facility Diversion
Association
Kansas Pharmacists Association
Maine Pharmacy Association
Maryland Pharmacists Association
Men's Health Network
Minnesota Pharmacists Association
Mississippi Pharmacists Association
Missouri Pharmacy Association
National Alliance of State Pharmacy
Associations
National Alliance On Mental Illness
National Association of Boards of Pharmacy
National Association of Chain Drug Stores
National Association of Drug Diversion
Investigators
National Association of Manufacturers
National Coalition for LGBT Health
National Consumers League
National Grange of the Order of Patrons of
Husbandry
NeedyMeds
New Hampshire Pharmacists Association
New Mexico Pharmacists Association
Ohio Pharmacists Association
Oklahoma Pharmacists Association
Oregon State Pharmacy Association
Pennsylvania Pharmacists Association
Pharmaceutical Industry Labor-
Management Association (PILMA)
Pharmaceutical Researchers and
Manufacturers of America
Pharmaceutical Security Institute
RetireSafe
Rx Outreach
Rx Partnership
Texas Pharmacy Association
Virginia Pharmacists Association
Washington State Pharmacists
Association
PSM’s membership is the entire supply chain: manufacturers,
distributors/wholesalers, pharmacists, and patient advocates.

3. YouTube
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www.safemedicines.org
18 years studying safety (and counting!)
LinkedIn
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4. Agenda
● Challenges of current political dynamic
● How PSM approaches advocacy
● Major legislation related to counterfeit
medicine and drug interdiction
● Opportunities to make a difference

5. Challenges of the current political dynamic
● Significant polarization means common ground is hard
to find.
● Close split of Congress means it’s difficult to move
legislation.
● Physical safety issues at the Capitol have made it harder
to visit and tell powerful stories in person.
● Other priority issues may push ours to the backburner.

6. How PSM approaches advocacy
● Avoid partisan blame.
● Build long-term relationships with offices of
electeds.
● Focus on what is possible to maintain credibility
with staff.
● Support agencies doing the work, like our LEO
federal and local listening sessions.
● We talk about fatalities as poisonings vs. overdoses.

7. How we shepherd our family advocates
● We are careful with advocates, avoid being used for
partisan purposes.
● We help advocates prepare to tell their stories.
● We avoid grief for grief’s sake, talking always about
policy proposals that can make a difference.
● Educate victims not to exaggerate.
● When media is involved, we try to help filter friendly
opportunities.

8. Lisa’s story
Speaking to Congressional staff, media, and
policymakers at the PSM 2018 Interchange

9. Legislation related to counterfeit meds & fentanyl
● Tracking federal legislation
about counterfeit medicines.
● You can find our positions on
our website at the URL below.
● Our policy slate is approved by
our board of expert advisors:
victim advocates, pharmacists,
LEO, and drug wholesalers.
For our policy positions, see: https://www.safemedicines.org/policy-page

10. Scheduling of fentanyl analogues as controlled substances
● There are potentially thousands
of alternate fentanyl molecules.
● They should be controlled
substances, and are current
emergency scheduled.
● That emergency scheduling
ends February 18, 2022.
Visit https://safedr.ug/permanent
to learn more about fentanyl
analogues and why it’s important
that they are scheduled as a
controlled substance.

11. Federal budget for interdiction of fentanyl / fake medicine
● Nobody has ever studied the federal
budget for counterfeit medicine
interdiction.
● In 2022, we’ll study the 2023 budget to
see what Presidential requests fund
fentanyl and fake drug interdiction
work.
● We’ll work with advocates to find
opportunities to tell their elected
officials to keep those agency requests
at 100%.

12. DRUGS Act (domain name lock and suspend)
S.3399 / HR 6352
● Fake online pharmacies sell counterfeit
medicines, and have killed Americans with
fentanyl-based counterfeits.
● They are illegally dispensing medications
to Americans without a board of pharmacy
license in the states.
● This legislation would allow agencies like
the FDA and DEA to lock their domain
name if evidence of illegal drug selling is
found.
Watch our video on this legislation
and learn how you can help at
https://safedr.ug/DRUGS-Act

13. POWER Act (resources for LEO / First Responders)
S.2853 / H.R. 5382 (117th Congress)
● This bill would provide grants for state, local, territorial and Tribal
law enforcement agencies to purchase chemical screening devices
and train personnel to use them.
● The devices would address the backlog of drugs awaiting
laboratory identification. By alerting officers quickly to dangerous
substances in the field, they will ensure officers can test substances
like fentanyl safely.
● All law enforcement should have the necessary tools to protect
themselves and quickly take bad actors off the street.

14. CAST Act (pill press regulation)
H.R. 1303 (117th Congress)
● This bill would amend the Controlled Substances Act to prohibit the
knowing possession of a counterfeit pill press mold for a controlled
substance with intent to manufacture.
● Those found in possession of a Schedule I or II counterfeit substance
in a capsule, tablet or other form intended for distribution, shall be
fined and imprisoned for not more than 20 years.
● All sentencing guidelines would be in accordance with the Sentencing
Commission.
● Enhancing statutory minimums and increasing fines and penalties
will provide a stronger deterrence against criminals and criminal
organizations seeking to make easy profits from counterfeit drugs.

15. Blocking Deadly Fentanyl Imports Act was introduced….
S. 400 / H.R. 1098 (116th Congress)
● This bill would require a study of the production of illicit fentanyl in
foreign countries.
● Nations exporting illicit fentanyl without emergency scheduling of
fentanyl would be ineligible for foreign aid or export-import bank loans.
● The bill would close the loophole for illicitly manufactured fentanyl,
which is the primary driver of fatal fentanyl overdoses.
● These conditions already apply to countries which are major producers or
traffickers of illicit heroin, marijuana, cocaine and methamphetamine and
their precursor chemicals.
● It will also hold countries accountable for producing/manufacturing
fentanyl into the U.S.

16. …and then appeared in a larger legislative vehicle.
S. 1605 / H.R. 4350 (117th Congress)
● Calls for an International Narcotics Control Strategy Report to identify the
countries – and the extent feasible – that are the most significant sources of
illicit fentanyl and fentanyl analogues significantly affecting the U.S. during
the preceding calendar year (2020-21).
○ To include a description of the extent to which each country identified has cooperated with the
U.S. to prevent the articles or chemicals from being exported from that country into the U.S.,
adopted and utilizes scheduling or other procedures for illicit drugs similar to the U.S.
Controlled Substances Act, and following steps to prosecute individuals involved in the illicit
manufacturing or distribution of fentanyl and fentanyl analogues.
● Directs withholding or limiting of assistance to:
○ Those countries designated as illicit fentanyl countries without scheduling procedures or failed
to adopt and utilize scheduling procedures for illicit drugs
○ Those countries designated as lacking the ability – or have not taken any significant steps – to
prosecute criminals for the manufacturing and distributing of fentanyl analogues

17. Opportunities to get involved
● FEB/MAR: Write a letter to your Senators endorsing
the permanent scheduling of fentanyl analogues.
Other opportunities, including letters to the editor
and Senate meetings are possible.
● YEARLONG: Write to your Senators and
representative about the DRUGS Act.
● MAR/APR: Look for PSM’s analysis of the federal
budget to support interdiction of fentanyl and fake
pills
● APR/MAY/JUNE: Join PSM in advocating for full
funding of interdiction efforts.
● JUL through DEC: Lay groundwork with Senate
offices for 2023 by meeting them and talking about
the importance of the crisis.
States where we have letters to
Congress from families on
fentanyl analogue scheduling

18. YouTube
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Facebook
www.safemedicines.org
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