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FDA Needs To Step It Up

by Guy Villax
April 22, 2013 | A version of this story appeared in Volume 91, Issue 16

This guest editorial is by Guy Villax, chief executive officer of the active pharmaceutical ingredient manufacturer Hovione. He is also vice chair of the industry consortium Rx-360, and a board member of the European Fine Chemicals Group, a section of the European Chemical Industry Council that represents manufacturers of fine chemicals.

The heads of the U.S. Food & Drug Administration and the European Medicines Agency (EMA) acknowledge that they don’t have full control over the quality of off-patent medicines. Despite changes in regulations, problems persist. FDA must move beyond enforcing compliance—and add incentives.

Up to 80% of prescriptions today are filled by generic medicines. These bring billions of dollars of savings annually to U.S. consumers partly because of low-cost production of active pharmaceutical ingredients (APIs) thousands of miles away. However, growing demand for cheaper medicines has attracted bad players that care only about short-term gains. They undercut the price of APIs by ignoring Good Manufacturing Practices or, worse, by falsifying products. Given health agencies’ limited ability to inspect facilities worldwide, noncompliance is the bad players’ competitive advantage.

Reputable manufacturers are committed to high-quality APIs and patients’ safety. These companies invest in people, science, technology, and infrastructure to ensure compliance. They stake their reputations on successful inspections by FDA. Yet as prices erode, reputable players have no option but to exit the manufacture of unprofitable products, causing drug shortages.

FDA and EMA have been working together to overcome their limited ability to enforce compliance worldwide. By inspecting facilities jointly and acting upon each other’s recommendations, they are building trust in each other’s inspection system. But waste and duplication continue as FDA inspectors still inspect European facilities and vice versa. Both agencies remain handicapped in inspecting facilities in Asia, where many quality problems originate.

FDA is taking other steps to ensure the quality of generic APIs produced far from the reach of its inspectors. For example, it has established collaborations with Asian medicine agencies to share know-how on detecting falsified medicines.

Meanwhile, companies dedicated to supplying high-quality products have banded together to combat low-quality APIs. They have formed Rx-360, an industry consortium committed to ensuring that patients get the medicines they expect. The group shares information and develops processes to ensure the integrity of, and the quality of materials in, the pharmaceutical supply chain.

One recent victory is the Generic Drug User Fee Amendments in the U.S., which requires industry to pay user fees to help defray the costs of reviewing generic drug applications and inspecting facilities. In 2013, these user fees will total about $300 million. Also this year, the European Union will begin enforcing the Falsified Medicines Directive, which applies more stringent standards for inspection of API manufacturers.

Yet serious problems remain. As FDA Commissioner Margaret A. Hamburg recently noted, manufacturing problems are delaying approvals of some new drugs. Such delays are inexcusable but not surprising in a regulatory environment that is limited to publicly shaming noncompliance.

FDA needs to complement the stick of compliance with the carrot of recognition for companies that advance the science of manufacturing. FDA should recognize companies that are in compliance and well ahead of the game because of best practices or contributions to standard setting.

FDA should consider creating a “dean’s list” of outstanding manufacturers. Companies on this list would be those that demonstrate consistently robust manufacturing systems, implement FDA initiatives to improve manufacturing such as Quality by Design and Process Analytical Technology, enable IT-based remote inspection, participate in standards setting, behave proactively when faced with problems, and allow FDA inspector training in their facilities.

Recognition from FDA as a high performer would help companies stand out in the marketplace and drive firms to continually improve.

Views expressed on this page are those of the author and not necessarily those of ACS.


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