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HDMA SUPPORTS FOOD AND DRUG
ADMINISTRATION AND STATE OF UTAH FOR CONTINUED EFFORTS TO
COMBAT DIVERSION AND ILLEGAL DISTRIBUTION OF PRESCRIPTION
DRUGS
Arlington, VA — May 2, 2005 — The Healthcare
Distribution Management Association (HDMA) strongly supports the United
States Food and
Drug Administration (FDA) and the State of Utah for their continued
efforts to enforce federal
and state laws that prohibit the diversion and illegal distribution
of prescription pharmaceutical products. The FDA and the State
of Utah reported last week
a series of indictments for the alleged illegal distribution of
diverted drugs.
In the indictments announced last Friday, the FDA reports more than
40 drugs were affected and were purchased by unsuspecting consumers in more
than 80 pharmacies nationwide.
“The diversion of pharmaceutical products is a crime that endangers
public safety and cannot be tolerated,” said HDMA President and CEO
John M. Gray.
Drug diversion is defined by the FDA as the practice of illegally buying,
selling or otherwise distributing prescription drug products outside established,
legal distribution systems that assure medication quality.
“An over-riding responsibility of our nation’s healthcare distributors,
with manufacturers and pharmacies, is to ensure the safety, quality and integrity
of the products they distribute,” said Gray. “Drug diversion
is a dangerous, illegal and unethical practice that puts lives
in jeopardy. Anyone
who knowingly engages in diversion or other illegal distribution
activities is engaging in criminal behavior and should be prosecuted
to the fullest extent
of the law.”
HDMA has a strong record of fighting in the states for stricter licensing
and more uniform regulations designed to help prevent diversion and other
criminal activities associated with drug diversion and counterfeiting. Specifically,
HDMA has recommended state legislators and regulators require tighter standards,
including:
- Criminal and financial background checks
to be conducted by state licensing authorities prior to issuing
a license
- Conducting a physical inspection prior to issuance of license,
with regular periodic inspections of all licensees conducted
thereafter
- Publishing the dates of the first and most recent inspections,
and
- Notifying appropriate parties upon license suspension, revocation,
expiration or other relevant action
- Requiring applicants to submit uniform, consistent and comprehensive
business information (such as included in HDMA’s Recommended
Guidelines for Pharmaceutical Distribution System Integrity) .
- Requiring a “designated representative” in each facility
run by the licensee, who would demonstrate knowledge of the industry,
its laws and regulations.
Consumers are urged by the FDA to visit http://www.fda.gov/bbs/topics/answers/2005/ANS01353lists.html, where the Agency has posted a list of the pharmacies and locations that may have received suspect drugs.
About HDMA
For more than 125 years, HDMA has worked with members to secure a safe,
efficient and reliable healthcare distribution system that is able to provide
life-saving health products and services. HDMA members are responsible
for ensuring that billions of units of medication are safely delivered
to tens of thousands of retail pharmacies, hospitals, nursing homes, clinics
and other provider sites in all 50 states in the most efficient manner
possible. HDMA members are a vital link in the healthcare system, providing
highest-quality solutions that remove costs and empower providers to deliver
care more effectively. Through our advocacy activities, HDMA operates at
the forefront of healthcare and ensures that members’ perspectives
and businesses are understood and addressed in legislative and regulatory
arenas. |
