Grace Graham Keynote Address at the Food and Drug Law (FDLI) 2025 Annual Conference, Washington, D.C. May 16, 2025

Speech | In Person

• Speech by: Grace Graham ; Deputy Commissioner for Policy, Legislation, and International Affairs - Food and Drug Administration

Thank you. I’m delighted to be here today to address this prestigious group of food and drug lawyers and policy experts.

It’s truly special to address you as the recently appointed Deputy Commissioner for Policy, Legislation, and International Affairs.

My interest in FDA policy began when my biomedical engineering professors at the University of Virginia occasionally mentioned, shall we say, differences of opinions with FDA policies and approaches.

I was fortunate to begin my career after leaving Charlottesville getting to work on FDA policy at the HELP Committee with truly wonderful colleagues and mentors.

And as I look around the room, I see so many familiar faces who have provided advice, guidance, and expertise throughout the years as I worked on the last three medical product user fee reauthorizations and the 21st Century Cures Act, among others.

Now, it is an honor to be on this side helping the FDA achieve its mission for patients.

The two main priorities working with Congress this year are:

(1)    Appropriately funding the FDA to make sure we address the public health challenges we face as well as take advantage of the amazing innovation happening all around the U.S.

(2)    Reauthorizing the Over-the-Counter Monograph Drug User Fee Program, which expires September 30 of this year.

And of course, there are additional authorities we are always happy to discuss with our counterparts in the legislative branch, such as those to help us better understand and address the global supply chain, better tackle illicit vaping products coming from China, and streamline the regulatory pathway for both innovators and their generic and biosimilar competitors.

In addition to the work more familiar to me up on the Hill, as the Deputy Commissioner at OPLIA, I’m excited to dive into the other aspects of this role, including working with state and local governments, foreign regulatory counterparts, and others across the Executive Branch to advance the many public health priorities of the Trump Administration, of HHS Secretary Kennedy, and of FDA Commissioner Makary.

The FDA’s mission has never been easy, with competing views of how much uncertainty to allow, second guessing of the FDA’s risk-benefit decisions, rapidly advancing technology, and more complex and global supply chains for everything from the foods we eat, the vitamins we use in animal feed, and the medical products American patients and families need.
 
But there are three main buckets of issues I’d like to focus on today, and make progress on while I'm at the FDA:

1. Make America Healthy Again
2. FDA’s Global Work
3. Supporting Innovation

All while reducing unnecessary regulation that can distract from true public health priorities.

MAHA

First, the FDA plays a key role in Secretary Kennedy’s Make America Healthy Again Initiative.

Most obvious places to start are looking at the nutrition of and chemicals used in the food supply, all while working to reduce foodborne illness outbreaks.

Since the beginning of this Administration, there has been a renewed focus on chemicals in food, the likes of which I haven’t seen from the FDA in my 10 or so years working alongside the agency.

As a mom of young kids with a busy job, I relate to not wanting to spend extra time and effort to understand what is in the snacks and food I hand to my kids and the impact of that on their long-term health.

But between social media, news stories, and peer regulators making different choices and releasing conflicting information, it is not easy.

There is a huge role the FDA can play, with others like NIH, to get better data and help communicate that information to families looking for this information.

The FDA is also focused on infant formula nutrition and supply.

I worked on Capitol Hill during the shortage in 2022, and the letters from moms and dads driving to 3, 4 stores only to find empty shelves were heartbreaking.

Since starting at the FDA, I've seen nothing but dedication to ensuring the supply in the U.S. is safe, and an openness to bringing new, innovative products to market.

Just this week, we released a Request for Information to support the first comprehensive update of the nutritional requirements of formula since 1998.

And we can work on that while ensuring a robust supply for the U.S.

No parent should be losing additional sleep wondering if there is going to be enough formula to feed their new baby.

MAHA is broader than just foods.

Many drugs are used today in ways that were not envisioned or supported by the data collected at the time of approval, and with many having gone generic, the incentive for studying and updating labels is low.

Medical devices can help Americans better track their own health needs before they get sick and creating conditions for more of these products and information to be available without a prescription can maybe help some avoid more severe disease.

FDA has been front and center of the Make America Health Again initiative, and will continue to be.

Global Supply Chains, Clinical Trials, Manufacturing

Second, I have been diving into all the challenges and opportunities presented by the increasingly global nature of clinical trials and reliance on foreign countries for many of the products families consume and doctors and hospitals need to see patients.

I know you heard about some of this in more detail already from my colleague Mark Abdoo, who I feel quite fortunate to have on our team, but I want to mention a few priorities.

More and more innovators are choosing to move their trials overseas where it is faster and cheaper to conduct clinical studies, or licensing drugs that have already had studies conducted in other countries.

And it is going to take all of us working together to reverse that trend. The average time from trial site identification to completing the startup process is nearly 8 months.  

The FDA does play a part, and we can look at streamlining and modernizing regulations, such as Good Laboratory Practices which haven’t been updated since the 1970s.

But it is going to take many of us working together, including hospitals, Institutional Review Boards, electronic health record companies, clinicians, patient organizations, and industry to address this growing challenge.

And we need to address it, because, as a result, the studies that innovators may hope to rely on for FDA review aren’t as representative of the U.S. population as they need to be, which can lead to further delay and duplication.

The U.S. also could lose some of the infrastructure needed to perform this research, hampering our competitiveness in the future.  We’d like to bring these studies back so we’re considering ways to streamline our existing regulations.

In addition to trials, we are too reliant on countries that may not have the best interest of the U.S. in mind for the manufacture of critical medications.

Today, 73% of all FDA-registered manufacturing facilities of active pharmaceutical ingredients and 52% of all FDA-registered finished drug manufacturing facilities are located outside of the United States, with China as a leading supplier.

On May 5, President Trump issued an Executive Order titled Regulatory Relief to Promote Domestic Production of Critical Medicines. It’s intended to facilitate the restoration of a robust domestic manufacturing base for prescription drugs, API, and starting materials.

A key concern has been the length of time it takes to build pharmaceutical manufacturing facilities in the United States.  

Industry estimates suggest that building new manufacturing capacity for pharmaceuticals and critical inputs may take as long as 5 to 10 years.

Again, not all of this is due to the FDA – there are a myriad of federal, state, and local requirements for new construction ranging from building standards and zoning restrictions to environmental protocols.  

But the FDA plays an important role, and even expanding existing capacity or modifying existing production lines to produce new or different products can require extensive permitting and regulatory approval.

The FDA is undergoing a review of existing policy to provide clarity with the goal of reducing the amount of time it takes to get a new domestic pharmaceutical manufacturing facility operational.

And this theme could play into user fee reauthorization discussions as well.

Currently, generic facilities pay higher fees outside the U.S. to help address the cost difference in ensuring compliance with FDA regulations, and that may be a concept worth expanding to other product areas.

In addition to reducing red tape, we are thinking creatively about incentives the FDA may be able to provide to reward good quality or investment in emerging technology here in the U.S.

The recent EO also seeks to make sure that foreign and domestic manufacturers are treated the same in practice as they are in regulations.

One way to do that is to expand the number of foreign unannounced inspections. The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries.

While inspections of U.S. facilities are typically unannounced, foreign firms often have weeks to prepare.

Last point I’d like to make on the global front, as the authority responsible for regulating a little more than 1 out of every 5 dollars spent by Americans, the FDA plays an important role in supporting negotiations of trade instruments or agreements.

There are non-tariff or regulatory barriers that impede access to foreign markets for American companies and can be useful in making sure American consumers, relying on foreign food and medical products, can be confident in the quality of those products.

It is a priority for the FDA to leverage the Administration’s ambitious America First trade agenda to harmonize regulatory requirements in a way that strengthens consumer protections and frees American industry from complying with duplicative or extraneous regulatory requirements.

Facilitating Innovation & Competition

Facilitating innovation is something I have focused on my entire career.

Many of you may have found yourself in health care because of a personal story or drive to make changes for patients.

Working on Capitol Hill, you meet with patients, families, and parents of those with rare diseases often.

And those stories remain with you. One of the main goals of my then boss, Chair Lamar Alexander, in the 21st Century Cures Act, signed in 2016, was shortening the 10-12 years it takes to develop a new medicine.

And that is a priority of this Administration as well, as demonstrated by Dr. Makary’s first announcement as Commissioner to move away from animal testing and prioritize the development and use of more effective, human-relevant methods.

Dr. Makary has also spoken about the need to be flexible when it comes to rare diseases, and part of my role is to make sure that flexibility is reflected in FDA policies.

The Prescription Drug User Fee program began as a way to facilitate innovation, instead of leaving paper applications to sit unreviewed for months or years.

And these user fee programs have grown to provide key funding for the FDA, without which it could not achieve its mission for American patients. But as we look toward the next reauthorization, it is time to take a step back and think about if the fee structures and amounts have any unintended consequences.

The perception of a drug company handing over $4+ million to the FDA at the time of their application submission does cause some of the American people to question the outcome of those reviews.

It is worth exploring whether and how restructuring and simplifying the user fee programs may help rebuild trust in the FDA and its decisions, and take advantage of the upcoming reauthorization to do so.

Inevitably, when talking about innovation, the high costs often associated with such innovation often come up. President Trump is continuing to make health care affordability a top health care priority.

In his first term, President Trump took numerous actions aimed at lowering prescription drug prices, including speeding up the development of lower-cost generic medicines and biosimilars and creating a pathway for states to import lower cost drugs from Canada.

In April, Executive Order 14273 Lowering Drug Prices By Once Again Putting Americans First has a few sections of importance to the FDA.

It asks us to take a look at current approval practices not only for generic drugs and biosimilars – those products most associated with lower drug prices -- but also combination products and second in class brand name drugs - and come back with some administrative and legislative recommendations within 180 days.

When it comes to the Section 804 Importation Program, FDA is taking steps to streamline and make it easier for states to obtain authorization without sacrificing safety or quality.

Currently, states and Indian tribes may submit importation program proposals to FDA for review and authorization.

Since issuing a final rule on the program in 2020, five states—Colorado, Florida, Maine, New Hampshire, and New Mexico—have submitted proposals to the FDA while Vermont submitted a concept letter to HHS and Office of Management and Budget.

In January 2024, Florida’s proposal was the first to receive FDA authorization.

It would be best for American patients if drugs regulated in the U.S. and available through U.S. supply chains and insurance system could meet their needs, but that clearly is not the case today.

The FDA stands ready to help make sure patients can access the drugs they need while also making sure the drugs are safe, effective, and made to U.S. quality standards.

Deregulatory

Now many of you may have questions about the possibility of tackling these three big priority areas, and the many other important priorities I don’t have time to go into today, given the deregulatory focus. The answer is we absolutely can do both.

President Trump’s Executive Order 14192 - Unleashing Prosperity through Deregulation, is better known as the 10 for 1 order.

Under this order, for each new regulation issued, at least 10 deregulatory actions must be taken to ensure that the cost of planned regulations is responsibly managed and controlled through a rigorous regulatory budgeting process.

To meet the obligations of this EO, we have a number of ideas for deregulation, and we’re confident it won’t hamstring us from issuing necessary regulatory documents.

We also welcome your ideas, and just earlier this week, HHS and the FDA issued a Request for Information on a deregulatory plan, and we welcome your input.

We’re working both with the department and others across the administration to ensure that our policy priorities are advanced while still meeting the requirements of this order.

These are early days for the Trump Administration and for the new leadership at the FDA.

I hope you’ve come away with a better understanding of the many pressing and important issues before my office and the FDA as we strive every day to Make America Healthy Again.

Thank you.