Stiffer Enforcement at the FDA - Agency officials promise swift action against violators of drug safety and quality regulations. - BioPharm International


Stiffer Enforcement at the FDA
Agency officials promise swift action against violators of drug safety and quality regulations.

BioPharm International
Volume 22, Issue 6


Drug safety legislative proposals and FDA initiatives reflect the impact of globalization in biotech and drug manufacturing on drug safety and quality. Such "supply chain fragmentation and geographic dispersion of drug manufacturing add new risks," said CDER director Janet Woodcock at the FDLI meeting. Foreign drug manufacturing sites now exceed registered domestic facilities, and the volume of drug products made overseas continues to rise.

An eruption in apparently intentional contamination of imported food and drug products, including heparin, pet food, and infant formula, has prompted a more deliberate FDA effort to examine the factors behind incidents involving dilution or substitution of ingredients in drugs and foods primarily to increase profits. At a public meeting last month, agency officials heard from manufacturers and other parties on ways to predict, prevent, and address economically motivated adulteration (EMA). Attendees discussed which types of products are more vulnerable, how manufacturers track and verify product components and ingredients, where supply chains are open to abuse, and what analytical methods can best detect contamination.

Randall Lutter, FDA deputy commissioner for policy, defined EMA as the "fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain." This may involve diluting or watering down products, as in increasing the inactive ingredient in a drug. The FDA noted that dramatic shifts in product supply, perhaps to additional companies or new regions, could signal fraudulent activity. EMA may involve expensive biologics that are relatively easy to engineer, or less costly drugs that are widely used. At the public meeting, academic experts described models able to detect shifts in supply chains that can signal fraudulent activity. Roger Williams, CEO of the US Pharmacopeia (USP), urged broader FDA and industry support of efforts to update USP monographs that set a standard for product quality. The USP was in the process of revising the heparin monograph when the contamination crisis hit, Williams said, noting that "that revision came too late."

Manufacturers backed wider use of accredited third-party inspectors to audit foreign producers of active and inactive ingredients, required registration of all ingredient producers, and stiffer penalties for drug counterfeiting and adulteration. Martin Van Trieste, vice president for quality at Amgen and a member of the Pharmaceutical Research and Manufacturers of America (PhRMA) Quality Technical Group, voiced support for a proposed Qualified Trusted Importer Program (QTIP), a voluntary certification program for qualified and compliant importers.

Van Trieste also described industry efforts to form the Rx-360 consortium to develop best practices for supply chain management and new approaches for supplier auditing and adulteration detection. The group held a launch meeting earlier this month to discuss audit models and methods for monitoring suspicious events. Such efforts, he noted, would benefit from the assurance that manufacturers can share information on suppliers and other issues without running afoul of antitrust laws.

Criminal elements have entered into the drug supply chain, and it's only a question of when and where EMA will emerge again, Van Trieste predicted. The short supply of antivirals in a pandemic influenza outbreak, he commented, provides the "perfect opportunity for someone to come in and make a quick buck." The industry and the FDA, he advised, have to think like the criminals to detect adulterated products.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,

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