Wholesale Distribution Senate Bill 759 Workgroup: Target Date for Implementation of Electronic Track and Trace Pedigree Technology for Maryland

Re: Wholesale Distribution Senate Bill 759 Workgroup: Target Date for Implementation of Electronic Track and Trace Pedigree Technology for Maryland

Dear Sir/Madam:

The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment in response to the Board of Pharmacy’s (Board’s) request for information from stakeholders regarding industry readiness for the implementation date for the electronic track and trace pedigree technology for Maryland. BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers, and related organizations. BIO members are involved in the research and development of health care, agricultural, industrial, and environmental biotechnology products. In particular, many of our members are involved in the research and development of life-saving therapies and play a critical role in delivering treatments that both prolong life and reduce the burden of disease for patients worldwide.

Biotech Industry Securing the Safety of Maryland’s Drug Supply

BIO commends the Board for its commitment to securing Maryland’s drug supply against counterfeit drugs and biologics. The biotechnology industry has been proactive in combating counterfeiters, and has taken steps to secure drug and biologic products with holograms, color shifting dyes, and numerous other anti-counterfeiting technologies. In addition to these product-based security features, many companies have put in place integrated programs to protect their medicines. These processes often include:

-Full-time, dedicated staff to ensure company-wide vigilance in the fight against counterfeiting.
-Contractual requirements for distributors to buy directly and only from the manufacturer, and to report any evidence of product diversion or counterfeiting.
-The use of secure distribution practices to prevent a drug shipment from being stolen, tampered with, or otherwise interfered with in transit.
-Investigation of all complaints received from patients, health care providers, and others in the chain of distribution and use.

Current Industry Efforts to Create Electronic Track and Trace Pedigree Technology

In November 2007, BIO conducted a survey of our members to ascertain timelines and milestones toward creation of electronic track and trace pedigree technology. It should be noted that the creation and implementation of new electronic technologies to track the
distribution of drug and biologic products is a tremendous undertaking for large
pharmaceutical companies and small biotech companies alike. These changes in business
practice will have profound consequences for the highly complex operations of
manufacturing facilities, packaging lines, distribution centers, and the operations of third party
partners and logistics providers.

Our survey results show that the manufacturers we represent are actively engaged in the
process of working toward the development of an interoperable track and trace system
that will benefit the industry, the supply chain, and all consumers of drug and biologic
products. There is no quick or simple solution to addressing this problem. Companies
responding to our survey indicated diverse levels of readiness.

Barriers to Implementation of Electronic Track and Trace Requirements

As manufacturers work toward electronic track and trace, numerous implementation
barriers have come to light. Specifically, companies continue to struggle with
technological obstacles, a lack of clear standards, and business process limitations. At
the forefront of concern for most manufacturers, and other members of the supply chain,
is the fact that to date there is no uniform, agreed upon standard for track-and-trace
technology. Additionally, companies are working to overcome the substantial business
process system changes, validation issues, interoperability issues, and hardware issues.

There are also outstanding challenges related to packaging and labeling. Modifications
will be needed for packaging lines and these projects require validation per FDA Good
Manufacturing Practice (GMP) requirements. Packaging line modifications pose a
significant concern due to the inherent risk that the validation will not prove successful
and may result in lost manufacturing capacity that could lead to supply disruption.

There are also specific concerns related to biologic products. A particularly difficult
issue facing manufacturers of biologic products relates to the extent that biologics will
have to be reworked/relabeled to comply with the electronic track and trace laws.

Biologic manufacturers face major cold chain issues and impediments to ensure that track
and trace technologies do not affect the biological stability of our products. Most
biotechnology drugs are complex, protein-based biologics that are produced by living
systems and are particularly vulnerable to changes in their environment. Biologic
manufacturers must ensure their products are safe from chemical impurities following the
application of the apparatus to be used to track-and-trace the product. With this goal in
mind, manufacturers are deliberately and methodically working toward implementing the
safest and most appropriate system possible. BIO member companies do not want to
make premature decisions or adopt incomplete or inadequate track-and-trace technologies
that may be detrimental to the pharmaceutical supply chain and consumers of prescription
drugs.

Target Date for Industry Implementation

The biotechnology industry has developed more than 200 drugs and vaccines that have
helped millions of people worldwide. Improving the lives and well-being of patients is our first priority. The adoption of electronic track and trace technology should support
patient safety and public health. However, it remains unclear what effect currently
available track and trace technologies will have on biologic medicines. In order to ensure
that Maryland residents get the safest, most effective medicines available, additional time
is needed to study what impact track and trace technologies will have on our industries
products.

On behalf of the biotechnology industry, including the hundreds of biotechnology
companies located in Maryland, we respectfully request that the Board exercise its
authority to delay the establishment of a target date for implementation of electronic track
and trace pedigree technology. The biotechnology industry will continue to work with all
segments of the supply chain, ensuring that the standards, distribution processes and
technologies employed will further protect the public.

Conclusion

We thank the Board for the opportunity to provide our comments and look forward to
continuing to work with the Board and all members of the supply chain to fight
counterfeit drugs. If we may be of further assistance on any of the topics addressed
above, please do not hesitate to contact us.

Sincerely,

John R. Gibson
Manager, State Government Relations
Biotechnology Industry Organization (BIO)