Drug Quality Concerns Spur New U.S. FDA Oversight Effort

Drug quality concerns, such as those that have banned U.S. sales of generic medicines from several Indian manufacturing plants, have spurred regulators to create a new unit to sharpen their oversight.

The Food and Drug Administration is establishing an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic and over-the-counter drugs, Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, said today at the Bloomberg health-care summit. The FDA is talking with the industry to develop data that may signal which manufacturing plants are straying from standards and need inspection, she said.

The agency now collects such information only during inspections. The thrust of the effort would be to head off potential concerns before the agency wields penalties such as banning products from troubled factories, Woodcock said. FDA Commissioner Margaret Hamburg has been in India the past week and met with generic-drug companies to discuss quality.

“We want to use leading indicators,” Woodcock said in an interview after her appearance via webcast at the summit in New York. “These people aren’t in trouble yet but they could be.”

Ranbaxy Laboratories Ltd. and Wockhardt Ltd. have been banned from selling drugs to the U.S. from some plants in India that experienced quality issues. In the latest incident last month, a fourth Ranbaxy facility was banned from U.S. exports after FDA inspectors found drugs were re-tested to gain favorable results after initial analyses failed.

Public Trust

“All companies must understand that quality is the basis for the public’s trust and confidence in their products and maintaining high quality standards is part of the cost of doing business,” Hamburg wrote today in a blog post on her trip.

Hamburg said the new office will “improve our oversight of quality throughout the lifecycle of a pharmaceutical product.”

In addition to her discussions with drugmakers, the FDA chief signed an agreement with her counterpart in India to tell regulators there when agency inspectors are inspecting plants and allow them to join to observe U.S. standards.

In 2012, the FDA was given the power to collect fees from generic-drug makers in part to pay for an increase in inspections of facilities outside the U.S. The agency was also permitted to request records in lieu of conducting an inspection, Woodcock said.

The FDA is working with groups such as the Pharmaceutical Research and Manufacturers of America and American Association of Pharmaceutical Scientists to determine how often it will ask drugmakers to submit quality data, she said.

Lawmakers in Congress are scheduled to hear from doctors, researchers and patient advocates Feb. 26 in a briefing on whether substandard generic drugs are reaching the U.S. medical system from overseas. The briefing will feature Harry Lever, a Cleveland Clinic cardiologist who has said generic drugs for heart failure made by India-based companies often don’t work the way they should.

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