We recently met with Jeffrey Gibbs, Director of the Washington, DC law firm of Hyman, Phelps & McNamara, in London. We wanted to know his impressions of the differences in the UK ecosystem vs the US and what UK companies should be thinking about in terms of their preparation for engaging with the FDA. Here's what he said:
I recently had the pleasure to spend nine weeks working in the UK. Naturally, this has lead to many questions.
Why was I in the UK?
I came to the UK for several reasons. As a US-based FDA lawyer, I have a number of clients in the UK and elsewhere in Europe. Using the London offices of Fieldfisher as a base allowed me to spend more time with these companies, and to meet people who had previously been voices on a phone call or names on an email. Another goal was to meet health care companies I had not previously assisted and help them navigate the very complicated US regulatory regime, and to explore opportunities to collaborate with organizations like MedCity.
Finally, I came to get to know the UK better, both in London and elsewhere. This goal was fully met, getting to tour London and other places, including Edinburgh (where I met my wife years ago, but that’s a different story.) After experiencing the Beast from the East and record-setting heat, I now appreciate why weather is something everyone talks about.
What are my impressions of the UK ecosystem?
I had the chance to meet with a number of start-up UK companies. I was extremely impressed by the creativity and technological sophistication. There are a lot of novel, exciting products being developed by very talented people, especially in the digital health area.
I was surprised to see how strong an ecosystem it is, with multiple facilities where start-ups can share space with like-minded companies. There are also venues for connecting with other resources, such as MedCity, that compare favorably with anything I have seen in the US.
How do the rules of lawyers differ between the UK and US?
For better or worse, the US regulatory system is far more legalistic. There are many reasons, including historical and cultural.
One of the starkest illustrations of the difference is the headcount at FDA. There are over 100 lawyers in the Office of Chief Counsel at FDA, and many other lawyers in other parts of FDA. This far dwarfs the number of lawyers within UK regulatory bodies.
Similarly, there are far more US lawyers in private practice specializing in FDA matters than UK counterparts. My firm has 35 lawyers, almost all of whom focus on FDA issues. That is more than the total number of life science lawyers in the entire UK.
Moreover, US FDA lawyers have become very specialized. My practice focuses on devices, diagnostics, and medical technology, including digital health. Some of my colleagues in my firm work only on drug approval issues. UK life science lawyers have to handle a much broader portfolio of products.
In addition, because FDA regulation is so legalistic, lawyers play a larger role in the US. It is very common for me to go to meetings at FDA with clients; that is apparently not the case in the UK. Because of the nature of the FDA system, US lawyers also can play a direct, significant role in the product approval process, such as helping to develop strategy, reviewing applications, and handling appeals.
What advice do you have for companies looking to enter the US?
- Think carefully about your intended use and then clearly define it. The intended use plays a key role throughout the regulatory process.
- If the product needs to be reviewed by FDA, use the pre-submission process. Even seemingly simple submissions can be complicated. The pre-sub process can eliminate many mistakes.
- Do good science. Ultimately, most applications will succeed or fail based on the data. Make sure studies are well-designed and well-conducted. Companies often don’t subject their data to outside review before submitting. It is helpful to have neutral, skeptical reviewers take a probing look at the data. It is better for them to spot possible flaws or ambiguities than FDA.
- Don’t make a flawed submission to meet a deadline. There is a lot of pressure to get work done quickly, especially if there are internal or external deadlines. However, a submission with mistakes will haunt the applicant. A company’s prospects can be badly hurt if a disorganized, incomplete submission is made. I appreciate it’s hard to resist the time pressure, but the long-term consequences of a bad submission can be staggering.
- Recognize that this is a confusing, complicated process. Do your research – there are lots of resources – and seek help when you need it. Even experienced companies can find this process to be challenging.
When should companies start to develop their FDA strategy?
Because the US is such a large and important market, many UK companies plan to enter the US. There is no single answer as to when to start developing a US strategy because there are many factors. However, in general, earlier is better. This is particularly relevant if you are generating data; it is far more efficient to use a common dossier for Europe and the US.
For devices, FDA has developed successful programs that make it easy to obtain early feedback. The pre-submission process enables device companies to obtain comments on important questions, such as study design, proposed intended use, and statistical plan, before generating any data. In fact, you can submit a pre-submission even before the device is developed. Getting FDA’s comments early can save a lot of time and money later. Early feedback is also essential for drugs and if you are unsure if your product will be regulated as a device or drug.
Am I glad I came?
Jeffrey Gibbs is a Director of the Washington, DC law firm of Hyman, Phelps & McNamara, P.C. He is Chairman of the Board of the Food and Drug Law Institute.