PDMA Services
The Prescription Drug
Marketing Act ("PDMA") was enacted in 1988 to address certain prescription drug
marketing practices that have contributed to the diversion of large quantities
of such drugs into a secondary grey market. These marketing practices including:
the distribution of free samples, the use of coupons redeemable for drugs at no
cost or low cost, and the sale of deeply discounted drugs to hospitals and
health care entities, have helped fuel a multi-million dollar drug diversion
market that provides a portal through which mislabeled, subpotent, adulterated,
expired, and counterfeit drugs are able to enter the nation's drug distribution
system.
In 1990, the US FDA
published final federal regulations mandating state guidelines for enforcing
minimum requirements on prescription drug storage and security, as well as on
the treatment of returned, damaged, and outdated prescription drugs.
Further, wholesale drug distributors were required to establish and maintain
inventories and records of all transactions regarding the receipt and
distribution of prescription drugs and make these available for inspection and
copying by authorized law enforcement officials (21 CFR 205).
Achieving and
maintaining PDMA compliance can be a complex and substantial undertaking
for any pharmaceutical organization. We have experience in the
development and enforcement of PDMA compliance programs. CompliaPharm can help guide you in understanding and
avoiding issues that could result in fines or, in even more serious cases,
possible criminal indictments for noncompliance. CompliaPharm
can assist with:
- Development of
policies and SOPs for PDMA compliance including details for enforcement
of disciplinary action against employees or contractors who violate
company policies and procedures or applicable healthcare program
requirements.
- Development of
monitoring processes to ensure that drugs are not diverted. This
includes audits of the sales force, monitoring of marketing promotions,
physician signature audits, and tracking and trending of sales force
inventories.
- Due diligence
with customers and wholesalers.
- Guidance to
Compliance Officers or Corporate Compliance Committees including the
development of lines of communication with employees.
- Creation and implementation of regular, effective
education and training programs
for all employees involved in PDMA regulated activities.
- Audits and other risk-evaluation techniques to monitor compliance, identify problem areas, and assist in the reduction of identified problems.
- Inventory tracking processes.
- Ongoing guidance on the key compliance issues of PDMA and state regulations.
- Defining what constitutes a significant loss reportable to the FDA.