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THE PETITION PROCESS

To many, the petition process can seem confusing and complicated, but, in reality, it is reasonably straight-forward.  The concept and rules of the Citizen Petition can be found in Part 10 of Volume 1 of Title 21 to the U.S. Code of Federal Regulations. While there are several details involved in the petition process, we’ll keep this explanation of the Petition Process simple.

The Process Made Simple

The regulations allow for a “Citizen Petition” to be filed with the U.S. Food and Drug Administration asking the FDA to “issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action.” This statement simply means that any person (or company) can file a Citizen Petition to the FDA that asks the FDA to either do something or not do something. 

While that explanation may sound broad, it is. A Petition may be filed on really any subject matter that the FDA is involved with.  Of course, the FDA has administrative authority over many things, so Petitions can include requests for actions on food, drugs, and even things like laser light shows. The topics can be specific to a particular product or broader on issues that affect the entire industry. At FDAPetitions.com, we focus only on pharmaceutical products.

A Citizen Petition may be filed at anytime, and law firms often file them on behalf of a client such as a pharmaceutical company.  So, sometimes we will not know the real identity of the filer.  Petitioners file the Petitions with the Dockets Management Branch of the FDA.  Once received, the Petition is given a number, and the number reflects the year of filing and the type of Petition.  For example, a Citizen Petition will be designated with a “P” as in 2005P-0008, an “N” for a Notice, a “G” for Guidance.  There are many other types of letters and categories of filings.

The Petition must contain certain things such as clearly stating what the Petitioner is asking the FDA to do and a statement of grounds for the request.  After the Petition is filed, anyone can file comments about it, and the Dockets Management Branch will then send the Petition and any comments to the appropriate divisions within FDA for resolution. The regulations give FDA 90 days to respond.  Now, that does not mean that every Petition will be decided within 90 days.  While some are, most are not.  Some Petitions can even take years to sort through.  However, FDA can follow the regulation by giving a tentative response within the 90 day time period. 

Once the FDA decides, there really is no formal process to appeal the decision.  Typically, the market will render the decision as final, or a company might take the FDA to court if it does not feel the decision follows the law.

Why Petition?

As FDAPetitions.com focuses on the pharmaceutical industry, the Citizen Petition is typically used in three circumstances:

1.  By brand companies when they want to raise issues of product standards, safety, patent extensions, bioequivalence, or something else product specific or when a regulation affects them as a whole.

2. By generic companies when they want to gather more information about a marketed product, gain generic approval for a similar, yet unapproved product (often referred to as a “Suitability Petition”) or when a regulation affects them as a whole.

3.  Really, by anyone else. For example, you might see a Petition filed by a physician group asking for modified standards or by professional organizations requesting that a product be taken off the market for safety reasons.

Is the Petition Process Necessary?

Yes.  The Petition process is necessary for two reasons.  First, it allows companies to make formal requests of the FDA.  The formal request is made public, so that everyone is aware of the request and it also helps to establish a sense of fairness for everyone involved.  The process enables the public, companies, other stakeholders, and FDA to work together to resolve important issues.

Second, there is a legal concept called “exhaustion” that needs to be satisfied.  Exhaustion of Remedies is a legal concept that courts will use when questions come before the court.  In most circumstances, the court will require that the administrative process or agency have a chance to resolve an issue before the court will.  For example, if the issue regards an interpretation of an FDA regulation, a court might refuse to consider it until after the FDA has interpreted it.
 

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