Download con`t - Conference of Western Attorneys General

CONFERENCE OF WESTERN ATTORNEY GENERALS:
“Transnational Crime in America”
Combating Illegally Imported Prescription Drugs and
Devices Through State Attorney General Offices
Bryan Smith
Allergan Regulatory Counsel
January 31, 2013
Agenda
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Background of Issue
Federal Law & the FDA
Allergan’s Multi-Pronged Approach
State Laws
Questions & Answers
Importation v. Re-importation - Terms
• Importation – bringing into U.S. from a foreign country
– Considered unapproved product
• Re-importation – U.S. to a foreign country and brought back
into U.S.
– Under PDMA, it is illegal for anyone other than the drug’s
original manufacturer to re-import a prescription drug into
the U.S. that was manufactured in the U.S.
2 Problem Areas in the US
• Illegal Actions of Wholesalers/Distributors
– Federal law prohibition
– Recent FDA action
• Illegal Actions of Healthcare
Provider/Purchaser
– Providers either knowingly or
unknowingly purchase drugs/devices
from importers
– Consumer fraud and patient safety
concerns
– Reimbursement/false claims issues
Federal Law
• FDA regulations prohibit the interstate shipment (which
includes importation) of unapproved new drugs (21 U.S.C.
section 331)
• Unapproved new drugs include foreign-made versions of U.S.
approved drugs
• FDA is sensitive to the issue
– "We appreciate that there is a significant cost differential
between drugs available here and those in other
countries/areas. However, many drugs sold in foreign
countries/areas as 'foreign versions' of approved
prescription drugs sold in the United States are often of
unknown quality with inadequate directions for use and
may pose a risk to the patient's health."
Why would the government want to
prohibit importation of drugs?
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It is illegal to import drugs into the United States under the United States Federal
Food, Drug, and Cosmetic Act (21 U.S.C. § 331).
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Concern for the safety of the people who take those imported drugs.
– Allowing importation of drugs greatly increases the risk that more dangerous
counterfeit drugs will be circulating through the United States.
– No way to track these drugs from start to finish and ensure their quality.
– No way to regulate what ingredients the drugs contain and in what amount.
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Potential punishments for illegally importing drugs include imprisonment and fines.
For example, anyone who violates the law against “reimporting” prescription drugs
originally made in the United States shall be imprisoned for not more than 10 years
or fined not more than $250,000, or both. (21 U.S.C. § 38).
Recent FDA Action – Dec. 2012
http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm330610.htm#Text
FDA Statement re Illegal Imports – Dec. 2012
“FDA urges the health care community to examine its
purchasing practices to make sure that products are
purchased directly from the manufacturer or from
state-licensed wholesale drug distributors in the
United States. Health care professionals, pharmacies,
and wholesalers/distributors are valuable partners to
protect consumers from the risks of unsafe or
ineffective products that may be stolen, counterfeit,
contaminated, or improperly stored and transported.
The receipt of suspicious or unsolicited offers from
unknown suppliers should be questioned, and extra
caution should be taken when considering them.”
http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm330610.htm#Text
Recent FDA Letter to Doctors re Illegal
Importation (Nov. 2012)
“Such products put patients at risk of exposure
to ineffective or dangerous products. In
virtually all cases, importing or causing the
importation of unapproved prescription
medications from foreign sources violates the
Federal Food, Drug, and Cosmetic Act and is
illegal.”
http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm330610.htm#Text
Unlicensed & Foreign Suppliers
EXAMPLES
Unlicensed & Foreign Suppliers -- Gallant Pharma
Unlicensed & Foreign Suppliers PharmaFillers
Unlicensed & Foreign Suppliers PharmaFillers
Unlicensed & Foreign Suppliers - PharmaFillers
Example of Purchasers
Example of Purchasers - Coupon/Discount Sites
In the News…
FDA warns counterfeit botox may have been shipped to 350 US clinics
CBS News
WASHINGTON Botox and other medications made by foreign suppliers may have been
received by more than 350 U.S. medical practices, the Food and Drug Administration
warned doctors. The FDA said in a letter sent last month, which was released publicly
Is importation of drugs into the United
States a big problem?
• Importation is increasingly becoming a more serious problem.
• The FDA has tracked this increase and reported that in the past decade,
the amount of importation of counterfeit drugs has increased significantly.
• Each day, thousands of individual packages containing prescription
drugs are imported illegally into the U.S.
• Volume has grown to exceed the capability of FDA field personnel to
properly process
• In a typical fiscal year, FDA's Office of Criminal Investigation (OCI)
opens between 31 and 54 cases involving counterfeit drugs. Some
cases could revolve around an individual, and others could involve
multiple players and investigations.
More information about criminal investigations by the FDA can be found at
http://www.fda.gov/ICECI/CriminalInvestigations/ucm123067.htm
What are the consequences of using
imported drugs?
• Consumers often will not get the safety, therapeutic effects, or
reliability of the drugs that they need
• Legitimate manufacturers of pharmaceuticals suffer. Importers take
advantage of all of the research, testing, and development that
these US companies put into creating their products by simply
copying the end product. This is done without FDA supervision and
results in a lower-quality drug.
• Health insurance providers are being defrauded when healthcare
professionals use these imported drugs and file for reimbursement.
– This violates state and federal law and exposes healthcare
providers to False Claims Act and medical malpractice claims.
Why FDA Action Isn’t Enough
• HCPs may still purchase drugs/devices
– Tempted by “lower prices”/higher margins
– Lack of knowledge/information on issue
• Resources Issue
• Coordinated, Multi-Pronged Approach
• States have civil authority to address issue
• Complaints are local
• AG can coordinate with Medical/Pharmacy Boards
State Laws
• State laws vary
– Some address the wholesaler/illegal importer
under the state’s Pharmacy Practice Act
– Some address unprofessional conduct of
healthcare practitioner under the state’s Medical
Practice Act
– Some states have no applicable law at all
• State laws may be Criminal or Civil
What is the Role of the AG re Illegally
Imported Drugs/Devices?
• Understand state law or gap in state law that would govern
control of illegally imported drugs
• Many states have no law
• May fall under “Unprofessional Conduct” provision in statue
• What is the potential civil/criminal action that could be taken?
• Do laws need to be clarified?
• Understand which overseeing governing boards will handle a
complaint should one be generated
• Learn how the AG and its Consumer Protection Division may
influence
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Case Study: Nevada
• During the 2011 Legislative Session, NV updated their Medical Practice Act
through AB 537
• Action taken against healthcare practitioner who purchases drug/devices
• AB 537 written to create “criminal” offense
17. Knowingly procuring or administering a controlled substance or
a dangerous drug as defined in chapter 454 of NRS that is not
approved by the United States Food and Drug Administration,
unless the unapproved controlled substance or dangerous drug:
(a) Was procured through a retail pharmacy licensed pursuant to
chapter 639 of NRS;
(b) Was procured through a Canadian pharmacy which is licensed
pursuant to chapter 639 of NRS and which has been
recommended by the State Board of Pharmacy pursuant to
subsection 4 of NRS 639.2328; or
(c) Is marijuana being used for medical purposes in accordance with
chapter 453A of NRS.
Nevada – Enforcement Action on Purchasing HCP
• Good media attention and fines collected
(http://www.lasvegassun.com/news/2012/sep/11/stateboard-reprimands-doctors-including-one-whod-/)
– Need to hit importers in the pocketbook to deter it
• Policing of illegal imports occurs on regular basis when
another doctor complains
• Filing complaints and new centralized process
– http://medboard.nv.gov/Forms/ComplaintInteractive.
pdf
Questions?
Please Feel Free to Contact Me
Bryan E. Smith
Allergan, Inc.
2525 Dupont Drive
Irvine, CA 92612
[email protected]
Tel: (714) 246-3735
Fax: (714) 246-4774