FDA Announces Two Initiatives to Modernize Drug Quality Programs

By: Janet Woodcock, M.D., and Michael Kopcha, Ph.D., R.Ph.

Patients expect and deserve high-quality drugs – this means consistently safe and effective medicines, free of defects and contamination. To satisfy these important expectations, the FDA strives to make sure that FDA-approved drugs are manufactured to meet quality standards to ensure that every dose is safe, effective, and capable of providing its intended benefit.

Janet Woodcock

Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research

Quality metrics are used in a variety of industries to monitor the quality control systems and processes that ensure standards are met, and to identify opportunities for manufacturing improvements. For the pharmaceutical industry, the use of quality metrics offers potential benefits to patients, manufacturers, and the FDA – including the potential to better combat drug shortages.

With these benefits in mind, the FDA has announced two new voluntary programs – the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program – in response to stakeholder requests for continued dialogue on quality metrics, and to provide methods for industry to engage and inform the FDA’s use of them in the future. The programs will also help drug manufacturers to gain a better understanding of how quality metrics are a common feature of quality culture, and support improvements in product and process quality.

Feedback from early adopters and manufacturers who implemented quality metrics programs to address manufacturing problems, as well as independent academic research supported by the FDA, indicates that a manufacturer’s overall quality program benefits from the use of quality metrics. Quality metrics, such as data on the rate at which manufactured lots have been rejected for failing to meet established standards, can help manufacturers monitor quality control systems and drive continuous improvement efforts. For the FDA, data on quality metrics can help us better assess risk when scheduling inspections. This has the potential of decreasing the frequency of surveillance inspections for lower-risk establishments and narrowing the focus of on-site inspections conducted.

Michael Kopcha

Michael Kopcha, Ph.D., R.Ph., Director of the Office of Pharmaceutical Quality, FDA’s Center for Drug Evaluation and Research

The proximal cause of many drug shortages are quality issues such as substandard manufacturing facilities or processes. Quality metrics can be useful in identifying situations in which a drug supply disruption may occur, which can help mitigate potential future drug shortages. This will help to reassure patients that quality medicines will be available when they need them.

  • The Quality Metrics Feedback Program solicits information from drug manufacturers and sponsors that have implemented and are currently using quality metrics programs. The FDA is encouraging applicants eligible for Type C meetings as well as abbreviated new drug application (ANDA) holders to submit meeting requests to the FDA to discuss quality metrics for specific products. As part of the feedback effort, the FDA is also beginning a pilot study to gain feedback from other types of establishments where these types of meetings are not applicable, such as active pharmaceutical ingredient suppliers, over-the-counter monograph product establishments, and contract manufacturing organizations (CMOs).
  • The purpose of the Quality Metrics Site Visit Program is to provide on-site, firsthand learning opportunities to the FDA staff involved in the development of the FDA Quality Metrics Program. The Site Visit Program also is intended to provide stakeholders with the opportunity to explain the advantages and challenges they’ve experienced when implementing and managing their quality metrics programs.

The FDA’s new initiatives continue to enhance the focus of the conversation between the FDA and drug manufacturers to better understand – and make use of – quality metrics programs. We are confident these efforts will improve both the efficiency and the effectiveness of drug manufacturing, helping to assure a reliable and high-quality drug supply.

Janet Woodcock, M.D., is Director of the FDA’s Center for Drug Evaluation and Research

Michael Kopcha, Ph.D., R.Ph., is Director of the Office of Pharmaceutical Quality, FDA’s Center for Drug Evaluation and Research

Quality: A Recurring Theme During My Visit to India

By: Margaret A. Hamburg, M.D.

As one of the Seven Wonders of the World, the Taj Mahal is not only one of India’s most sacred symbols, but one of the finest, most carefully designed architectural structures in the world. As I studied the details of the marble and embedded precious stones of the mausoleum during a recent visit to the city of Agra, I could not help but reflect on the care, craftsmanship and quality of the work that took just over two decades to complete. It was evident as I walked along with hundreds of other visitors in socked feet that those responsible for building the Taj and those that are preserving the centuries old structure are committed to extraordinary quality.

Commissioner Hamburg with A Didar Singh

FDA Commissioner Margaret A. Hamburg, M.D., and A Didar Singh of the Federation of Indian Chambers of Commerce and Industries.

This vision of quality and care remained with me when I met with executives from pharmaceutical and food exporting companies operating in India. The roundtable meetings, organized by the Federation of Indian Chambers of Commerce and Industries, were an opportunity for me to learn about two of the largest business sectors in India and to hear from business leaders about the challenges they are facing as a result of globalization.

One of the challenges cited by the pharmaceutical leaders is approval times for abbreviated new drug applications – the applications filed for generic drugs. I am happy to report that the FDA is working quickly to fulfil one of our commitments under the Generic Drug User Fee Act (GDUFA) – reducing the backlog of generic drug applications that were pending when the new user fee program went into effect on Oct. 2, 2012.  As of the end of January 2014, our Center for Drug Evaluation and Research had taken a formal action on 45 percent of backlogged generic drug applications. In December 2013 alone, the center completed 174 actions, including 30 full approvals for generic drugs.

GDUFA also requires that we step up our number of foreign inspections and gives us the funding to do so. Companies participating in both the pharmaceutical and drug roundtables said they were challenged by our heightened inspectional activities. I told them that every company supplying the U.S. market has the responsibility of ensuring that their products are safe, effective and of high-quality.

In my talks with regulators and companies here in India I have placed a great deal of emphasis on why quality matters. As I explained, quality is linked to product safety and without a direct focus on quality, the potential for patient harm increases significantly.

In recent years the FDA has identified significant lapses in quality by some companies operating in the U.S. and around the world. As a result, American consumers have had to endure greater risk of illnesses, recalls, and warnings about the products many of them rely on each day. This is unacceptable. Consumers should be confident that the products they are using are safe and high quality and when companies sacrifice quality, putting consumers at risk, they must be held accountable.

Regulatory agencies around the world share my vision for ensuring that consumers, patients and healthcare providers in all of our nations have access to high quality products. I am pleased that, as a global leader in the pharmaceutical and foods sectors, India will continue partnering with us to ensure that the companies exporting products to the U.S. are adhering to established quality standards.

On the home front, we at the FDA will also continue to increase our focus on quality. One way we are doing this is through the creation of a new Office of Pharmaceutical Quality that will create one voice for drug quality at the FDA and improve our oversight of quality throughout the lifecycle of a pharmaceutical product.

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.

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration