The FDA Citizen Petition ("CP") process is a widely used, but often seemingly fruitless tool by which interested persons and entities can seek to influence FDA policies and actions. Members of regulated industry, public policy advocacy groups, and individuals of all stripes have used the CP process over many years for various purposes. FDA petitions are public documents readily searchable by anyone, including industry, politicians, the media and ordinary individuals. FDA has the most detailed and organized set of rules and procedures of any federal agency for addressing such entreaties from the public. However, having such a detailed and organized system does not in any way guarantee that FDA will respond substantively and/or in a timely manner to any particular petition. 

FDA's regulations require that FDA “shall furnish a response to each petitioner within 180 days of receipt of the petition." (A specific subset of Petitions—those involving requests for FDA action that could impact the approval of a pending ANDA or 505(b)(2) application ("505(q) Petitions")—are subject to an additional set of FDA procedures and timing requirements). As a matter of general practice, however, FDA claims to meet its 180-day Petition response deadline by providing a terse and uninformative "tentative response indicating why the agency has been unable to reach a decision on the petition…."  21 C.F.R 10.30(e)(2). Once a tentative response is issued, however, the Petition may, and often does, fall into a black hole of uncertainty with little to no way of knowing when, or if, FDA may issue a substantive response.

The petition lag can be extreme. As reported by AgencyIQ, FDA recently responded to a petition filed fifteen years ago (in 2008), in which the petitioner asked the FDA to take various actions addressing online advertising for prescription drugs and restricted medical devices. The petitioner argued that YouTube videos promoting various drugs and devices failed to comply with rules and regulations applicable to other forms of promotion, which rules petitioner argued should be equally applicable to online promotion. FDA's belated response, however, was neither substantive, nor “tentative;” Rather, FDA sent a letter noting the passage of time and the lack of any activity on the petition and asked whether the petitioner wished to keep the petition active. After receiving no response within 30 days, the agency filed a memo to the docket declaring the petition “to have been voluntarily withdrawn without prejudice to resubmission.”

Take-Aways:

• Citizen Petitions offer a potentially useful tool for influencing FDA actions and policy, but relatively few have an immediately demonstrable impact on agency practices or actions.
• Indeed, for some petitions, FDA is not even the petitioner's primary intended audience; rather, given the public nature of CPs, some petitioners use the process as an amplified soapbox to garner attention from media, politicians or even the courts to their topic of interest or concern. 
• Other petitions are filed as a precursor to litigation against the FDA, in order to satisfy the “final agency action” requirement for bringing a lawsuit against the agency. Still, other petitions are filed when a company is, or believes it is about to be, targeted for enforcement action by the FDA, with the hope that triggering the petition review process may stave off or prevent such FDA enforcement action.
• Despite the usual delays and ubiquitous use of non-committal “tentative” responses by the agency, FDA does pay attention to issues and arguments set forth in Citizen Petitions and for issues of broad interest or significant concern, the agency may act in ways that are consistent with requests made in one or more petitions, even if “credit” (in the form of a letter granting a petitioner's request(s)) is not given to particular petitioners.
• In the case of the petition described above, FDA was well aware of the issues surrounding regulation of online promotion and was actively formulating policies and enforcement actions in this area. Indeed, FDA's current policies for online drug and device promotion reflect many of the positions advocated in the petition, and FDA arguably could have issued a brief letter “granting” the petition to the extent its current policies reflect those requested by the petitioner.
• FDA periodically engages in “petition cleanup” efforts such as this, and even more extreme examples of delay exist. In 2014, this author received an FDA letter inquiring about a petition filed by his firm in the early 1970s (!!) regarding FDA's regulation of saccharin (which was a huge health and policy controversy back in the day). FDA had never responded to the petition, the partner who filed it and the CEO of the client company were both deceased, the company for whom the petition had been filed was long since out of business, and the saccharin controversy had long since faded to obscurity. Yet FDA politely asked if we still wished to keep the nearly 40-year-old petition “active” (we let the FDA off the hook on that one!). 
• For those interested in filing an FDA Citizen Petition and actually receiving a substantive response, there are steps you can take to reduce the risks of your petition falling into the black hole of death, but the strategies vary depending on the specific product type and policy issues raised in your petition. 
• A petitioner must keep in mind that—like a super tanker at sea—even when FDA is inclined to change direction, its progress is slow, methodical, and often almost imperceptibly incremental. 
• Finally, “victory” in a Citizen Petition filing is often defined by seemingly small shifts in FDA positioning, or by simply by putting the petitioner's issues, concerns and requests in the public domain and officially in front of FDA decision makers, or in some cases, counterintuitively, even by receiving an FDA denial letter. 
• So don't shy away from filing a CP if you have issues or concerns you wish FDA to act upon. But be realistic and clear-eyed in your strategies and expectations when doing so.