Opening up lines of communication with the U.S. Food and Drug Administration (FDA) can often be intimidating for companies, and the process does not seem straightforward.  Fortunately, there are many ways of undertaking this process–whether it be because your company is finding ways to pre-empt damage, or figuring out how to address damage that has already occurred.  In this post, we will review some of the best ways to start interacting with the FDA.

Citizens Petitions

One way of reaching out to the FDA includes a Citizen’s Petition, which is a process through which companies can inform the FDA about an issue of interest pertaining to health policy.  This is a good way for companies to remain anonymous, because these petitions can be written on behalf of other companies or groups of companies.

Federal Register Responses

Another way of responding to the FDA is through the Federal Register, which is the official journal of the federal government which includes notices put out by the FDA.  Within these notices, the FDA will often list issues that they are dealing with, and request commentary on those issues.  This opens up opportunities for companies to respond, and give their input to certain FDA regulations.

Public Hearings

Going to public hearings is yet another option for companies to get in touch with the FDA.  These hearings are organized by the FDA, and offer companies a chance to talk with the FDA and voice their concerns and problems.  One notable hearing that happened recently was the hearing on cannabis and CBD, and how the FDA should deal with the farm bill.

Responding to Titled & Untitled Letters

Responding to untitled letters and 483s is another way to come into contact with the FDA.  Although these letters and forms indicate that the FDA has an issue with your company, it also offers an opportunity for companies to explain their side of the story, and give a bit more context.  It might also mean that your company has to admit fault, and explain how they will repair their mistake in accordance with FDA guidance. These kinds of conversations, however, must be structured carefully.

FDA Meetings

Meetings are yet another form of communication with the FDA.  The types of meetings can be broken down into three kinds: Type A, Type B, and Type C meetings.  Once your company chooses one and schedules a meeting, they should reach out and inform the FDA about what their exact plans are, and how they will be executed.  This type of communication must be structured in such a way that the FDA knows exactly what to expect–including what kind of opinion your company wants, what kind of information you will give them, and whether they can opine or not opine.

Formal Dispute Resolution Process

There is also the formal dispute resolution process, through which companies are able to reach out to the administrative law judge and set precedents regarding what can and cannot be legally done.  This kind of communication typically occurs in the context of civil monetary penalties, which can be in the millions of dollars.  

Appeals

Appeals are yet another way for companies to get into contact with the FDA.  Appeals to the Board offer a way for companies to voice their concerns about rulings by administrative law judges.  This is typically done in the case of civil monetary penalties, and it offers companies a way of challenging certain regulations and restrictions.

Communicating with the FDA is inevitable for developers, and it is critical for companies to work on building an ongoing, positive relationship with the FDA to ensure product success.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Play or on Soundcloud.

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The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.