arah McMullen is the Country Director for the FDA India Office. Her professional experience has included analytical method development and testing for multiple FDA-regulated commodities, establishment inspections, import operations and policy, and foreign office service. Her FDA career has spanned more than 20 years working as a chemist, tissue residue specialist, consumer safety officer, and leader. In the last nine years, she has focused on international arenas, including import operations and foreign office service. She reflects on these experiences and opportunities in the below interview.
Sarah McMullen: I started as the supervisor of our consumer safety officers and oversaw the inspectional activities of our investigators here across foods, clinical trials, and pharmaceuticals. After I was in that role for some time, the deputy position became available. I applied and was selected. Then again after some time, the director position was available, I applied and was selected. I’ve been serving as the country director since February 2021. Having served in several positions with the office has been incredibly helpful in understanding the operations and the needs in each area.
My career has spanned quite a bit. I started off as a chemist doing seafood chemistry, of all things. Then I started doing chemistry of other regulated commodities, including agricultural products, pharmaceuticals, and tobacco products. I did inspections across commodities. I worked in import operations for a few years and then came over to the foreign office.
Having a little taste of the different things the agency covers has been helpful. We regulate 21 cents of every dollar that’s spent in the United States, so it’s never a dull day here. We can be talking about heart stents, infant formula, pesticides on botanical products, pharmaceuticals, cosmetics—you name it, we usually have something come across our desk about it daily. It’s always interesting.
DIA: This office was established in November 2008, which means that it recently celebrated its 15th anniversary. What have been the major accomplishments of this office, and what is the size of the office relative to the scope of your obligations there?
SMc: When you talk about 15 years, there’s so much to talk about: We could talk about the number of inspections, the number of enforcement actions, the number of agreements, or the number of capacity-building events.
But I would rather focus on impact. Webster’s dictionary defines impact as “a marked effect or influence.” I would like to talk about the impact we’ve had on the context here. We create effects through our regulatory actions, through our inspections, being able to conduct compliance follow-ups. But we really carry influence in the relationships we build. As an agency, we focus a lot on our enforcement actions (which are very important), but we can’t discount the influence that relationship building can provide. That’s one of the things we’ve focused on building.
In India, there’s a decentralized structure for enforcement. Engaging at both the central and state level has been very important to ensure consistency of understanding of regulatory norms and best practices because, for a lot of activities, it’s the state regulator going into facilities, carrying out enforcement actions. We’ve had to work across these different contexts, across different commodities.
We have well over 20 government stakeholders, in India and around the region; when I started with the office, it was maybe five to 10. Now there’s well over 20 entities with whom we’re regularly engaging, sharing information, capacity building, and all of that builds influence. We’ve started to expand some of our engagements in the region, and when we talk about engendering voluntary compliance and understanding the regulations, relationships are key. Building those relationships informs decisions, shares best practices, and promotes greater regulatory consistency and predictability.
Some accomplishments related to that influence include a Memorandum of Understanding (MOU) with the central regulator for medical products. Under that MOU, we offer them an opportunity to observe our inspections. To date, they have observed over 900 of our inspections on medical products. That’s another way of sharing our best practices and how we oversee inspections in the medical product area. We also have developed relationships with some of the Indian states that have the highest number of FDA-registered manufacturing facilities in them. We’ve capacity built with their inspectorates, shared best practices, and come to better understanding of different contexts. India is a land of great diversity, and there’s a lot of opportunity to ensure consistency of understanding in regulatory and industry stakeholders.
I also want to mention that the FDA Commissioner came to India in September 2023, the first visit of a Commissioner in nine years. It was a great opportunity to push through messaging about quality: ensuring quality of products, quality of manufacturing, quality of data, quality in clinical trial integrity; quality should be the same regardless of the destination of the product. Commissioner Califf hit on all these areas with industry. We also had some impactful meetings with the government while he was here. That was a real pleasure, and another way that we celebrated our 15 years here.
Regarding staffing, if you ask any regulator and they tell you that they have enough staff, they’re not telling you the truth, because no regulator feels like they’re adequately resourced, human resources or otherwise. While I won’t talk about the specific numbers in our office, I will say it’s not enough for the work here. To that extent, we are looking to increase our staff to accommodate the increase in manufacturing and other FDA-regulated activity in India, especially for medical products.
We have staff across the commodities that are most prevalent here. The US gets a significant amount of food from India. Forty percent of our shrimp comes from India. Spices, rice, snack products, and dietary supplements are big commodities we get from India. We get about 40% of our generics from India, so clinical trials in support of those generics are also done here in India. We have dedicated staff on inspections and the policy side for foods, pharmaceuticals, and clinical trials.
DIA: What skills should people develop if they want to step into this regulatory space?
SMc: This is one of the things I love about FDA: we have experts of all stripes, including scientists, medical doctors, engineers, economists, and lawyers. This brings a lot of diversity of thought. When we talk about specific topics, troubleshooting, or even “thinking outside the box,” we have very vigorous discussions because we have such a wide range of backgrounds represented in the thought processes. For those who have an interest in serving overseas, there are a lot of opportunities with the agency. We need more investigators out at our posts. Feel free to visit our website or keep an eye out on LinkedIn and USAJOBS for opportunities!
Because we have time limitations for people in country, that whole personnel process of maintaining a footprint is difficult. We are currently looking for people with science backgrounds. We have had people here with legal backgrounds; that’s always helpful too. We have people with backgrounds in medical sciences and in pure sciences; we’ve had chemists, veterinarians, nurses, doctors, lawyers—it’s amazing. When I talk with our locally employed staff, engaging with people from other educational backgrounds has been invigorating for them as well.
DIA: What was the impact, globally and locally, of the pandemic on your office?
SMc: As you can imagine, it was pretty frightening for a time, especially when the pandemic first hit. I’d been in country about a year before, so I had an opportunity to get adjusted and travel to see a good portion of India and the surrounding area. When the pandemic hit, we had significant, extended periods of lockdowns. We were away from friends and family. It was a very harrowing time for our office.
The experience was difficult for everyone at the mission, including our locally employed staff. We lost several members of our mission to the pandemic. Everybody here is pretty close, so it was deeply impactful on the personal side. The effort in terms of maintaining morale, checking in with each other, was important and encouraged.
As I mentioned earlier, we get about 40% of our generics from India. India established export restrictions on essential medicines during that first wave. These are products we rely on in the US, and suddenly India put in export restrictions to make sure they had enough for their own domestic population. Many countries did similar things, but it was particularly concerning and potentially very difficult for us considering our heavy reliance on India. So, our office and the interagency here were able to work with industry and the government of India to demonstrate that industry had enough capacity to produce for domestic as well as for export use. We were able to help diplomatically to ensure the flow of essential medicines to the US when they would otherwise have been restricted from export.
The second wave here in India, the delta wave, was particularly devastating. Hospitals here were completely full. It’s hard to estimate the actual number of deaths and sickness. During that time, the US government brought a lot of aid into India. FDA here was asked to chair an Interagency Specification Task Force where we helped ensure that regulatory requirements, especially for medical products, were met for incoming aid. I wrote a blog for our FDA website called Doing the Needful which describes some of our efforts during that time. To feel useful and helpful during the pandemic was a privilege.
We also did a lot of work in the vaccine landscape. You’re aware of all the different vaccines that were coming to market, all the different platforms and technologies being leveraged. We were able to research and report on some of the innovations happening in the vaccine space.
On that note, the FDA Head of the Office of Vaccines Research and Review David Kaslow was recently here. We convened a panel at the World Vaccine Summit and talked about the need to implement these learnings to ensure that we put something in place that enables equitable access to vaccines when the next pandemic hits. COVID really highlighted some of the inequalities in experiences with and access to vaccines. Leveraging existing partnerships to ensure we don’t repeat that must not be forgotten as we start to gain distance from the pandemic.
DIA: With all due respect, how should the American public feel about the safety and efficacy of drugs and biologics imported from India?
SMc: First, we need to understand that industry and regulators have to work together. It’s a collaborative effort. We’re not in a “gotcha” game and they shouldn’t be in an avoidance game. At the end of the day, we should have the same shared collective objective of safe, effective, and accessible medical products.
We have a lot of ongoing effort here specifically focused on ensuring and maintaining quality of medical products. As I mentioned earlier, nine out of 10 prescriptions in the US are filled with a generic drug, and 40% of those come from India. This number is only going to potentially increase in the future as the government of India continues to invest in industry. Industry here is growing and will continue to hold a significant share of products coming into the US.
Anyone who watches the news will understand that through our inspections we continue to see noncompliance with regulations, and it’s been particularly disheartening to see data integrity issues in manufacturing as well as clinical trial conduct issues. We are working on several different avenues to address that. Some of it is through building regulatory understanding, through capacity building; we do that with industry, we do that with the regulator. For the willfully noncompliant, we rely on our inspectional capacity to detect and take appropriate action.
FDA is also formulating programs that “think outside the box.” There’s the Quality Management Maturity program where we are incentivizing business practices that prioritize quality practices that go beyond cGMP expectations; we see cGMP as a baseline and prioritize expectations above that. We’re looking for unique ways to incentivize and motivate those business practices.
We need products coming from India. India is very important in the small molecule space. You’ll see, especially when we have shortages, that a lot of it relates back to product quality issues, which we seek to address through these different avenues.
DIA: How does this office contribute to post-marketing drug safety or pharmacovigilance, locally and globally?
SMc: On the clinical trials side, with 40% of generics coming from India, a lot of the bioavailability and bioequivalence (BA/BE) studies done to support those generic drug applications are conducted here in India. Approximately 30% of FDA’s foreign clinical trial inspections are done here in India, with the majority of those relating to BA/BE trials.
For the India Office, the clinical trial space is about clinical trial conduct and clinical trial innovation. FDA is having a listening session with industry in Washington in March, looking to industry to tell us about their innovative clinical trial practices so that we can understand and adapt regulations and requirements accordingly. So many things can be leveraged in clinical trials: we have real-world evidence, we have adaptive designs, we have decentralized clinical trials, and we have digital health technologies, which are great for access but also introduce complications we haven’t previously had to work through.
As an agency, we really want to understand where industry is going. Just this past week, we engaged with the Indian Society for Clinical Research annual conference in Hyderabad to hear from industry where they’re heading on the clinical trial landscape. Industry is innovating, which they’re supposed to do, and as a regulator, we must understand where the innovations are heading so we can develop regulations to meet them. Any way that we can reduce that gap is better for everybody.
We’ve seen that a robust regulatory framework enables innovation and increases (even quickens) access to safe and effective novel therapeutics. We have to turn around the mindset that regulators are inhibitors of innovation, because having that robust framework in place helps people understand expectations and meet those expectations, and if those expectations are the same across markets, then you’ve increased access.
Pharmacovigilance is an area of global opportunity. With so many different reporting systems and different electronic medical records, understanding the information flow isn’t always easy. Our director of the Office of Surveillance and Epidemiology, Gerald Dal Pan, has been to India several times. He’s spoken at different conferences here and engaged with the regulators on best practices. There’s a lot of opportunity in pharmacovigilance that can be shared globally, as we look to better capacitate patients on self-reporting outcomes. A lot of pharmacovigilance in the US is patient-reported. They’re making connections between “I took a drug” and “I feel a certain way.” Not everybody in every country will have that same level of understanding, the connection and correlation, so recognition of adverse events is probably still more nascent in some of these contexts.
DIA: What didn’t we talk about that you’d like readers to know?
SMc: Did you know that FDA is a law enforcement agency? The law we enforce is the Federal Food, Drug, and Cosmetic Act. Our investigators have badges and FDA also has a criminal division, our Office of Criminal Investigations, and we engage quite actively in the counternarcotics space. We play a critical role in addressing substandard and falsified pharmaceuticals and diversion of pharmaceuticals and work together with other members of our US government interagency and the Government of India on these issues.
Some controlled substances and other pharmaceuticals have fewer restrictions on access in India than in the US, and so we see people buying these products in India and then shipping them through the mail to US consumers. They could be tramadol or other controlled substances, erectile dysfunction drugs—we see a lot of drugs that are controlled or not approved in the US come from India to the US through the mail.
We worked together across posts to plan and execute Operation Broader Sword in both our JFK (New York) and Chicago international mail facilities in the US. We intercepted and confiscated more than 500 parcels of illegal and illicit medical products. There’s a lot of work in that space, a lot of opportunities working together across agencies. This falls under our counter-narcotics working group, which is in a larger relationship with the Government of India to share information and best practices in that law enforcement space.
I also want to say that we’re looking to increase our overseas footprint and influence as an agency. We get products from over 150 countries around the world. There are more than 280,000 FDA-registered manufacturing or processing facilities globally. With that amount of product coming from everywhere, having FDA staff in these areas has been extremely helpful. We’re able to get places immediately when we need to be there for inspections. These are things we need to extend to other parts of the world that are either rising in significance to the US supply chain or raise concerns about product quality. Be on the lookout for that. Our Office of Global Operations is hoping to expand our staffing for some foreign offices and the number of offices, and thereby, our influence and our ability to engage further on the safety and quality of regulated products globally.