Medical devices and pharmaceuticals are heavily regulated. In the U.S., stakeholders have opportunities to communicate with regulators through pre-submission meetings, commenting on proposed regulations and draft guidances, and working with industry trade associations. But what is the right path for your particular company or concern?

During the 2023 MedTech Intelligence Regulatory Summit, Steve Silverman, President of The Silverman Group, and former member of the FDA CDRH, U.S. Department of Justice, and the Federal Trade Commission, and Patterson Shafer, Managing Director of FTI Consulting and strategic advisor to the FDA, sat down with MedTech Intelligence managing editor Inga Hansen, to discuss Regulatory Advocacy and the most effective ways to make your voice heard.

Understanding the Role of FDA

Before determining the best path through which you want to communicate with the FDA, it is important to understand the responsibilities of regulators. “If a company is taking advantage of a comment period two things are important,” said Shafer. “One is patient first. The FDA is very much focused on patient health and safety above all else. If you are making an argument, I wouldn’t base it in terms of convenience or self-interest. Whatever the fundamental issue is, make sure that the patient welfare is the fundamental end objective. The second thing is, if want to present your opinion, make sure it is data driven. More and more the agency is relying on data—even big data—so if you can present evidence to support your position, that is going to carry a lot more weight.”

Amplify Your Voice

Both Shafer and Silverman noted that many voices, aligned with the interest of the patient and supported by data, are going to be much more effective than a lone voice. “If you have an individual issue that relates to your company and your product, and you already have a communication pipeline with regulators within FDA to help you resolve that problem and get to a solution, then it may be unnecessary to engage with other stakeholders,” said Silverman. “In contrast, if the issue is one that affects a large group of outside stakeholders and affects them in the same way, then there may be value in collaborating and working, for example, through a trade association to get to an appropriate solution.”

Groups, such as MDIC and Advamed, can help elevate issues of broad concern and they offer the benefit of close relationships with regulators. “When there are issues that MDIC, for example, decides to bring to the FDA’s attention, FDA is going to listen—not necessarily give MDIC members what they are looking for—but there is going to be a conversation,” said Silverman. “So going through an industry association is very, very helpful.”

The drawback to professional associations is they may not choose to take up the specific issue you are concerned with. In these cases, bringing together your own consortia of stakeholders may be effective. “If there are four or five organizations that have the same concerns, someone needs to take the lead and say, ‘I am going to reach out to FDA and organize a discussion, and when I do so, I want to be able to communicate to FDA that I speak for my organization as well as your organizations,’” said Silverman.

Establishing Credibility and Making Contact

Getting involved now in industry associations and working groups can help lend credibility to your comments or input when an issue arises. “Participating, networking and being part of trade associations is important,” said Shafer. “The more you participate, the more you’re going to get to know the players.”

“Groups, such as MDIC have a number of initiatives that are active and clearly related to priorities for the FDA. Look at those initiatives, find out where you may want to raise your hand, join them and contribute,” said Silverman. “Because FDA is also at the table. So in a year or 18 months, when you are back in front of the FDA either individually or through the comment process or with a group of companies, there is a greater likelihood that the FDA knows who you are because they have worked with you, and they have had the chance to see that you are a credible, thoughtful contributor.”

In recent years, the FDA has made a commitment to better engagement with stakeholders and improving accessibility, which opens many doors for engagement, noted Shafer. “The FDA has made themselves extremely accessible to the industry, which has been a sea change over the past decade or so,” he said. “FDA wants to help get safe and effective products to patients. We run into the FDA at almost every conference we go to, and there are opportunities to walk up after an FDA town hall and speak to the people and start those discussions.”

When to Go it Alone

While working with industry associations or a group of stakeholders is beneficial, there are some instances where companies should approach the FDA on their own. “Once there is a formal comment process, companies need to follow the rules of that process,” said Silverman. “If you are an individual company and your product is in the midst of the review process, in my opinion the first stop on the bus has to be, ‘Can I resolve this issue on my own directly with the staff who are working with my product?’ Trying to engage other stakeholders at this point is, at best, really risky.”

Shafer also encourages companies to take advantage of presubmission interviews. “There is a fear of interaction during the presubmission process, but do reach out to the FDA during the presubmission process to discuss the science and the process,” said Shafer. “If you have a product or family of products that you are trying to advance through the review process, one on one is the only way to go.”