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FDA Needs Help to Monitor Drugs, but Industry is Equally Accountable

Washington, DC (Apr. 30)—US Food and Drug Administration leaders issued another cry for help last week. Center for Drug Evaluation and Research Director Janet Woodcock testified before the Senate Health, Education, Labor and Pensions (HELP) committee at an April 24 hearing, “Restoring FDA’s Ability to Keep America’s Families Safe.”

She pointed out, just as her colleague John Jenkins at the Office of new Drugs did in March, that FDA desperately needs more inspectors, more overseas locations, and more modern IT systems to carry out its ever-demanding global agenda.

Addressing the heparin contamination issue specifically, Woodcock explained how complicated even one drug application might be in today’s industry. Some applications to import generic drugs, she said, may cite 15 different facilities involved in the drug’s manufacture and distribution. One goal FDA has in mind to manage these complex supply chains is to institute an IT system that includes an inventory of every establishment importing products into the US, said Woodcock.

In addition to more in-depth databases, Woodcock suggested that the agency needs more authority to pursue violators in the pharmaceutical supply chain. “The FDA or any other regulator cannot test quality into products, and we cannot inspect quality into products. The FDA must have the tools to hold all these parties accountable,” she said.

The Government Accountability Office (GAO) estimated that it would take roughly $70 million per year for FDA to inspect all overseas facilities every two years, $16 million to $17 million of which would be required for sites based in China where contaminated heparin has been traced.

Although FDA clearly needs more funding, Woodcock did not give the Senate committee a specific price tag for the above projects. She did take the opportunity, however, to point out that industry must be held responsible for its products. “All parties throughout the supply chain—from the production of the API and the ingredients, through brokers, through distributors, through importers, to finished product manufacturers—must be held responsible… for assuring the quality and integrity of the products they produce,” she said.

Gerald Migliaccio, vice-president of quality at Pfizer (New York), pointed out some reasons behind current challenges in the supply chain. “Traditionally, pharmaceutical companies in the US have sourced active ingredients and drug products from within the US, from Europe, Japan, and other developed countries. Our suppliers and contractors in these countries operate within sophisticated regulatory environments with highly competent inspectorates. Most operate to internationally recognized standards established by the International Council on Harmonization (ICH). Therefore, they generally have effective quality systems that provide a high degree of confidence in the overall supply chain. Companies in emerging markets are operating in a developing regulatory environment with a novice inspectorate. Many have rudimentary quality systems or none at all.”

Migliaccio pointed out that education, evaluation, and enforcement are key to improving today’s supply-chain challenges, especially with regard to imported ingredients and drug products. “Before a US pharmaceutical firm can consider sourcing from these suppliers, it is imperative that the firm work with the suppliers to upgrade their quality systems and standards.” Pfizer has been carrying out its own model for such practices, including having a dedicated quality-assurance unit to evaluate and provide oversight to contract manufacturers.

William K. Kubbard, former associate commissioner for policy and planning at FDA, also expressed to the Senate HELP committee that FDA is operating under a budget and standards that were developed decades ago. He presented seven action items that could help:

1)  An immediate infusion of new appropriations for FDA’s drug oversight activities
2)  A requirement for GMP inspections of foreign drug-manufacturing facilities, with an immediate focus on drugs made in countries without a history of safe drug production and internal regulation
3)  Creation of a Foreign Inspectorate for FDA that is dedicated to inspecting foreign manufacturing facilities
4)  A requirement that all foreign drug producers register annually with FDA 
5)  Appropriations and a specific Congressional mandate to improve FDA’s IT systems
6)  A vigorous mechanism for testing drugs for ingredients or contaminants that are not approved for that compound
7)  Clear authority for FDA to inspect sites in foreign countries.

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