Remarks by Associate Commissioner Mark Abdoo at the Parenteral Drug Association India Chapter 10th Annual Meeting
By Mark Abdoo
February 21, 2023
(Remarks as prepared for delivery)
Good morning, everyone. Thank you for the warm welcome and introduction, and to the organizers for inviting me to speak with you this morning. Dr. Sarah McMullen, the Country Director for the FDA India office in New Delhi will be sharing specifics about our work in India and some of the things she and her team are seeing on the ground, so I am going to take a moment to speak more broadly about FDA’s global work, focusing on the why and the how, with a couple specific examples. And I will conclude by mentioning a few authorizing provisions that are relevant to product quality and oversight that appear in the Food and Drug Omnibus Reform Act (FDORA) and the “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act'” or the “PREVENT Pandemics Act”, in the Consolidated Appropriations Act of 2023 signed by President Biden on December 29, 2022.
FDA began engaging globally well before the rapid increase in imports caused by the efforts of manufacturers and producers regulated by FDA to lower costs and improve productivity, fueling a cycle in which the quest for efficiency led to increased production abroad and higher volumes of imported products for FDA to regulate.
And we primarily did so for a few reasons:
First, to become more effective and efficient. Globally aligning approaches to common problems allows us to be more effective in mitigating or managing them and relying on data and information collected by foreign regulators to support FDA’s oversight activities generates efficiencies so we can focus our own resources in areas of greater risk.
Second, to benefit patients and consumers … and industry too. International harmonization is a good example. International harmonization leads to improved efficiency in the regulatory review process, reduced time to get a product to the market, reduced patient burden through prevention of unnecessary duplication of clinical trials and post market clinical evaluations, and reduction of unnecessary animal testing without compromising safety and effectiveness.
Third, and perhaps most significant, to keep Americans safe, which often has the collateral benefit of improving safety in other jurisdictions as well. FDA’s foreign offices are a good example. Globalization fundamentally altered the United States’ economic and security landscape, and it demanded a major change in the way FDA fulfills its mission to promote and protect the health of the Ameri¬can people. Just as public health leaders have long recognized that disease knows no borders, FDA knows that product safety and quality no longer begin or end at the border.
This year marks the 15th anniversary of the opening of FDA’s first foreign office, in Beijing, China, and we are currently in the process of considering whether we need to adjust our overseas footprint to meet the challenges of the next 15 years. We didn’t open our foreign offices simply to expand regulatory cooperation, however. We opened them in response to a series of public health tragedies in which Americans were sickened or killed by poor quality or adulterated imported products, such as diverted and counterfeit glucose monitor test strips and economically adulterated and contaminated heparin.
Our foreign offices fulfill a critical role - they function as FDA’s eyes and ears in the country or region where they are located. Our staff closely follow regulatory and market developments, accumulating vital expertise over time. They spot trends in manufacturing and product safety and quality. They meet with industry and government, educating them about FDA’s regulatory requirements, building relationships that simply wouldn’t be possible by engaging from afar. And yes, our staff also conducts in-country inspections of manufacturing facilities.
My office - the Office of Global Policy and Strategy which, among other things, oversees the foreign offices, is a critical hub where information is collected, analyzed, and transmitted bi-directionally – back to HQ and our product centers to inform policy and risk-based decision making and to our foreign stakeholders. In this way, OGPS and the foreign offices significantly support the Agency’s work to advance quality and assure the safety and effectiveness of drugs and other FDA-regulated products.
As I mentioned earlier, in a moment, Sarah is going to show you how all this plays out bilaterally in our engagement with India.
OGPS also functions similarly in the multilateral context. A good example is the work we are doing in the World Health Organization Member State Mechanism on Substandard and Falsified Medicines. This unique governance forum brings together the 194 Member States of the WHO to develop strategies to mitigate the public health risk and harm caused by medicines that are falsified or of insufficient quality (substandard). Much as in the bilateral context, OGPS collects and analyzes information, leveraging headquarters, our product centers, and our foreign offices to inform policy and risk-based decision making in support of global coordination and information dissemination related to substandard and falsified medicines. One of the critical messages we transmit in this forum is that the ought to be one quality standard – not one standard for the United States, Europe, and Japan, and another for India, and yet another for Africa. We understand assuring that standard requires continuous evolution and improvement from regulators just as achieving it requires the same from industry.
Before I close, I want to turn to a few authorizing provisions from FDORA that fall into two buckets: emerging technologies and advanced manufacturing, and alternative approaches to facility inspections.
Emerging technologies and advanced manufacturing have long been priorities for the Agency and CDER has already established a variety of initiatives related to both, including the Emerging Technologies Program and the development of a research program to better understand the science of advanced manufacturing and support the FDA’s ability to approve quality, safe and effective drugs made by advanced manufacturing technologies.
Section 3203 authorizes the Emerging Technology Program and identifies the actions the program may take to support the adoption of and improve the development of innovative approaches to drug design and manufacturing. It also identifies the process for entities to seek grants or contracts under this program and requires FDA to issue or update guidance relevant to the program.
Section 3204 amends the 21st Century Cures Act to authorize FDA to designate National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing, consisting of institutions of higher education or consortia of institutions of higher education, to support the advancement and development of continuous and advanced pharmaceutical manufacturing technologies and practices no later than one year after the date of enactment.
And Section 3213 requires FDA to initiate a program for designating advanced manufacturing technologies within one year of enactment. Eligible technologies include methods of manufacturing that incorporates a novel technology, or uses an established technique or technology in a novel way, that will substantially improve the manufacturing process for a drug while maintaining equivalent, or providing superior, drug quality, including by reducing development time for a drug using the designated manufacturing method; or increasing or maintaining the supply of drugs in shortage or drugs that are life-supporting, life-sustaining, or of critical importance to providing health care. Applications for drugs, including biological products and active pharmaceutical ingredients of such drugs, that are manufactured using designated technologies would qualify for expedited application development and review and allow the holder of such designation, or a person authorized by the designation holder, to reference or rely upon, in a drug or biologic application, data and information about the designated technology for use in manufacturing drugs in the same context of use for which FDA granted the designation. It requires FDA to hold a public meeting within 180 days of enactment, issue draft guidance within 180 days of the public meeting and final guidance within two years of enactment regarding implementation of the program.
FDORA also changes FDA’s authorities related to inspections in several important ways, including improving FDA inspections (the title of Section 3616) by providing for FDA consideration of the compliance history of other FDA-regulated establishments in the country or region in which an establishment is located, including the history of violations related to products exported from such country or region, as a factor in establishing a schedule for risk-based inspections of drug or device establishments required to register.
And by amending section 704(a)(4) records requests authority to clarify that FDA may rely on any records or other information authorized to be inspected under section 704 of the FD&C Act to satisfy requirements that may pertain to a preapproval or risk-based surveillance inspection, or to resolve deficiencies found in such inspections, if applicable and appropriate. This amendment is significant in that it removes the barrier that previously prevented FDA from relying on records and other information collected pursuant to Section 704(a)(4) to satisfy surveillance inspection requirements.
It also in Section 3615 requires FDA to conduct a pilot program, starting no later than 180 days post enactment of the Consolidated Appropriations Act of 2023, in which FDA increases the conduct of unannounced routine surveillance inspections of foreign human drug establishments, evaluates the differences between such inspections of domestic and foreign human drug establishments, including the impact of announcing inspections, and posts a report of its findings and recommendations, including the number of unannounced inspections during the pilot program that would not be unannounced under practices in use prior to enactment, no later than 180 days after completion of the pilot program on the FDA website.
I am now going to turn it over to Dr. Sarah McMullen to speak specifically about India. Thank you.