The Draft Guidance for Industry on Good Importer Practices

Re: Docket No. FDA-2009-D-0675, OC 20091.

Dear Sir/Madam:

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Good Importer Practices. This guidance provides a useful quality systems framework for importers across all FDA-regulated industries to promote the safety of imported products. Biotechnology companies are currently leading significant efforts to further enhance the safety and security of biopharmaceuticals at every step of the supply chain and we encourage the FDA to minimize the potential for divergence between this guidance and current drug and biologic Good Manufacturing Practices regulations.

BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.

BIOTECHNOLOGY COMPANIES ARE LEADERS IN ONGOING EFFORTS TO FURTHER SECURE THE SUPPLY CHAIN:

BIO and its member companies work closely with the FDA to ensure that the United

States’ drug supply is safe, secure, and reliable, and that Americans can be confident that when they use an FDA-approved prescription drug or biologic, the medicine will be safe and effective.

In fact, FDA’s regulatory standards for biopharmaceutical current Good Manufacturing Practices (cGMP) are among the most rigorous in the world. BIO member companies routinely exceed those standards. Our members’ facilities that manufacture prescription drugs and biologics for the U.S. market must comply with cGMP requirements to ensure that their prescription drugs and biologics can be produced consistently and in accordance with U.S. laws and regulations. Manufacturers of finished dosages that use imported ingredients test and monitor the safety, purity, and consistency of those ingredients that they use in the manufacture of their products, and facilities are periodically inspected by FDA to ensure compliance with regulation. Under current regulations and best practices, many biotechnology companies routinely develop and deploy quality systems and controls to better understand their products, trading partners, and potential hazards that may arise during the product’s lifecycle. The proposed multiindustry Good Importer Practices document reinforces many of the concepts that the biotechnology industry has embraced and continues to implement in everyday practice.

Furthermore, many biotechnology companies are currently spearheading industry initiatives to further strengthen the biopharmaceutical supply chain beyond what is required by regulation. For example, Rx360 (www.rx-360.org) is a new international pharmaceutical supply chain consortium being launched by several BIO member companies. The mission of Rx360 is to create and monitor a global quality system that meets the expectations of industry and regulators, and assures patient safety by guaranteeing product quality and authenticity throughout the supply chain. The consortium is developing novel approaches to ingredient supplier auditing, endorsing best practices for supply chain management, encouraging the development of new supply chain technologies, and surveying the global marketplace for potential vulnerabilities.

Another promising initiative is the Qualified Trusted Importer Program (QTIP), a proposed voluntary certification program for highly compliant importers. The proposed program would assess the applicant’s internal processes and controls with respect to product quality, supply chain security and trade compliance. Upon review, companies that qualify as “trusted importers” would be afforded interagency green lane status and certain other benefits. Such a program would complement existing U.S. Government efforts to further secure the supply chain and would build additional safety into the supply chain by incentivizing medical product manufacturers and importers to adopt best practices. BIO encourages the FDA to consider endorsing the QTIP proposal as part of the U.S. Government’s overall efforts to continually enhance import safety.

GOOD IMPORTER PRACTICES SHOULD BE FULLY HARMONIZED WITH PHARMACEUTICAL cGMPs:

BIO recognizes that the draft guidance applies to all FDA-regulated industries – from drugs and biologics to food and cosmetics. As noted in the guidance, “Because of the wide variety of products and their production processes, the regulatory systems that apply to particular products, and the range of product and importer relationships, it is difficult to develop a set of detailed recommendations that fits every product.” (p.5) Due to those limitations, the guidance is drafted from a high-level perspective and cannot be expected to address the specific and unique security considerations inherent in importing biopharmaceutical products, intermediates and raw materials. As a result, the document as written may not have enough detail for biopharmaceutical importers to develop specific practices that can prevent or detect potential problems at critical points along the product’s life cycle. Due to the high level nature of the guidance, key stakeholders in the biopharmaceutical supply chain will need to continue to rely on cGMPs, current GMP guidances, and other best practices in order to deliver on the major objectives of draft Good Importer Practices guidance document.

While many of the proposed actions in the guidance are consistent with current pharmaceutical regulations, we are concerned that in some areas it seems the document is intending to add requirements for safety and security of drugs beyond the current regulations. For example, there is the potential for additional business process changes and resource implications related to the need for inbound route monitoring noting any changes to routes and/or ports; stricter controls over material inspection upon receipt (physical examination of product packaging and labeling); and risk based product sampling and testing by the importer or an independent third party to authenticate the product. These activities may sometimes provide value in the biopharmaceutical supply chain, but we request that it be made clear these proposed actions are recommendations, not requirements, and that the proposed actions be framed within the context of existing pharmaceutical cGMP regulations.

BIO believes that the guidance should make every attempt not to deviate from or contradict the cGMP regulations, and this should be further clarified throughout the document. We recommend that either:

1. The guidance (or an appendix to the guidance) specifically cross-reference the

Good Importer Practice recommendations against the pharmaceutical cGMP

regulations. This type of comparison between this guidance and specific cGMP

guidances and regulations would avoid redundancy and burden to FDA and the

pharmaceutical industry where appropriate controls and oversight currently exist.

This comparison should also clearly state any new recommendations in this

guidance document that may supersede cGMPs.

Or

2. Pharmaceuticals, biologics, and devices be specifically removed from the scope of the guidance since many areas of the draft guidance provide a level of detail that is generally captured within existing laws, regulations and guidance applicable to the pharmaceutical industry. A separate cGMP guidance could be issued to address more detailed good importer practices for drugs and biologics.

IMPLEMENTATION & COMPLIANCE:

BIO welcomes additional clarification around several issues that will help companies to implement the general recommendations of the guidance and continue to comply with cGMP regulations.

First, we request that FDA confirm that companies can utilize certifications from existing government programs, such as the U.S. Customs and Border Protection’s Trade Partnership Against Terrorism (C-TPAT) and Importer Self-Assessment (ISA) programs, or the Transportation Security Administration’s Certified Cargo Screening Program (CCSP), to demonstrate compliance with the proposed guidelines.Second, we request that FDA establish a process to affirm that existing pharmaceutical quality systems currently implemented comply with the intent of the guidance.

Finally, we request the FDA establish a timeframe for complying with the proposed recommendation that manufacturers obtain certification and evidence of compliance from suppliers (p.11). Without an adequate timeframe for implementation, this provision may lead to manufacturers to “renegotiate” supplier contracts outside of the standard budgeting and business cycles, which may lead to difficulties establishing new contracts.

An established time period in the guidance would help companies appropriately comply with this recommendation.

CONCLUSION:

BIO appreciates this opportunity to comment on the Draft Guidance for Industry on Good Importer Practices. We would be pleased to provide further input or clarification of our comments, as needed.

Sincerely,

/S/

Andrew J. Emmett

Director for Science and Regulatory Affairs