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.
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