Compliance doesn't end with approval: US FDA commissioner

At the end of the first day of her official trip to India and after a day of back-to-back meetings, the US Food and Drug Administration (FDA) Commissioner Margaret Hamburg responded by email to Business Today in an exclusive interview, the first ever to an Indian publication. She says quality will be one of its highest priorities in 2014 for the US FDA. Hamburg, the 21st commissioner of the FDA, insists  "commitment to quality manufacturing must be accepted  by everyone involved - from top CEOs to the foremen to line workers". Further, she says, FDA staff will work with Indian companies to identify problems and help self-correct.

Hamburg meets with top Indian pharma CEOs on Tuesday morning at a meeting organised by industry body Ficci.

Edited excerpts from the interview:

Q.Dr. Hamburg, this is your first visit to India. What are your expectations from this visit?
 
A. I am delighted to be making my first official trip to India as FDA Commissioner. India is an important strategic partner to the FDA, and I look forward to engaging with our regulatory counterparts in the coming days. Enhancing our existing relationships and identifying additional opportunities for collaboration are essential, and will play a vital role in promoting the health and safety of American and Indian consumers.

Q. Some of the leading companies from India, especially in the last one year, have been found wanting in meeting the quality, compliance and regulatory standards of the FDA.  What are you trying to do to ensure it is not a wider problem with companies out of India?   How does the regulatory compliance by companies in India exporting to the US compare today with those in China, US and Europe?

A. It's important to note that many Indian firms understand current good manufacturing practices (CGMPs) and use them. The problems encountered by FDA investigators in India are similar to those seen around the world in manufacturing. These include inadequate or poor quality systems implementation, data integrity issues, inadequate validation of various processes used in manufacturing or testing and product adulteration or contamination. While some Indian companies operate state-of-the-art facilities and meet CGMPs, others do encounter problems and operational challenges. Staff from the FDA's India office will work with these companies to identify the problems and will take the necessary steps to self-correct.  It's the FDA's responsibility to ensure that products distributed within the United States meet US requirements and standards for product safety and quality. That's why FDA has chosen to make quality one of our highest priorities in 2014. Whether innovator or generic, building quality is how companies must build their reputation and why patients and healthcare professionals will trust their products. Not only is quality critical to public health, but also it is the basis of the public's confidence in pharmaceuticals.
 
Q. There has been a plan to increase FDA's activity and presence in India, including setting up an office in Hyderabad, the third in India, after Delhi and Mumbai, please give us a yardstick you will like to see in terms of activity and presence over the next one year in India?

A. FDA's plans remain focused on Delhi and Mumbai, but we will increase our presence in India. In March 2013, we received approval from the Indian government to add seven drugs investigators. This will increase our presence to 19 American staff based in-country, including 10 dedicated specifically to drugs. Others include foods and devices inspectors, and policy analysts.
 
Q. FDA has been working closely with the regulatory authorities in other countries, particularly Europe, what is your plan to collaborate with the Indian regulator?

A. FDA's presence in India has allowed us to more effectively collaborate with our Indian regulatory counterparts and enables us to leverage our combined resources, ensure standards consistency and increase regulatory capacity, which includes information sharing, exchange programs and speciality training.  Through our India Office, the FDA also works to ensure that Indian manufacturers importing to the United States understand the risks associated with their products' processes and that they remain compliant to FDA's regulations.  These efforts allow the agency to continue ensuring that medical products moving in international commerce are safe, effective and of high quality.
 
Q. What was on top of your agenda in your meeting with the Indian regulator - the Drug Controller General of India G N Singh?

A. I had a productive meeting with Dr. Singh and look forward to continuing to engage with him on ways to promote the health and safety of American and Indian consumers.  As I noted earlier, enhancing our existing relationships and identifying additional opportunities for collaboration are essential, and this [was the] major focus of our meeting.
 
Q. Many companies in India who have received approvals from the FDA earlier are facing serious issues today. How much responsibility does the USFDA take for granting them the approvals in the first place? Is there anything the FDA wants to change within the organization to ensure fewer surprises later?

A. One of the required steps before FDA approves an application to market a drug in the United States is to ensure that the facility where the drug will be manufactured is in compliance with our current good manufacturing requirements. But pre-approval inspections are a snapshot in time. Compliance doesn't end with approval. Companies must instill and maintain quality practices so they remain compliant with the FDA's requirements. This commitment to quality manufacturing must be accepted by everyone involved - from top CEOs to the foremen to line workers.
 
Q. What is your plan to strengthen regulatory competence and compliance capabilities of Indian companies with manufacturing facilities exporting to the United States?

A. We are planning multi-year capacity building workshops for industry and regulators with the Indian Drug Controller General's Office and the Indian Pharmaceutical Alliance. These workshops will be organised in industrial cities of Hyderabad, Goa, Ahmadabad and Chandigarh and will focus on such topics as good manufacturing practices (GMPs), data integrity and quality systems in drug manufacturing.

The FDA remains confident that many companies understand and have implemented GMPs. We also remain vigilant and will take appropriate action if, or when, lapses, occur.
 
Q. Is the increased activity in India a result of FDA's findings on the ground or is it a result of the need to comply with the requirements of the new Food and Drug Administration Safety and Innovation Act (FDASIA) - Generic Drug User Fee Amendments (GDUFA) - that requires the FDA to achieve the same inspectional schedule for foreign facilities as domestic manufacturers, and to clear the backlog of applications by the end of the first five-year user fee authorisation period?

A. We've been focused on increasing our collaborative efforts and risk-based inspectional activity in India for a number of years.  As I've mentioned, India is a major global player in the production of pharmaceuticals and an important strategic partner to the United States. It's the FDA's responsibility to ensure that products distributed within the United States meet US requirements and standards for product safety and quality. The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 does require the FDA to inspect foreign and domestic drug manufacturing facilities.  By law we are required to achieve the same inspectional schedule for foreign facilities as domestic manufacturers, and to clear the backlog of applications by the end of the first five-year user fee authorization period.  
 
Q. India, we are told, has around 200 plants that have been approved by the USFDA. How important is India today for the US in terms of supply of drugs?

A. India is the second largest provider of finished drug product to the United States, and is an essential partner in ensuring the health and safety of American and Indian consumers.  Our office in India will continue to engage and partner with our Indian counterpart regulatory authorities to ensure the safety and quality of FDA-regulated products being exported to the US.