Under Federal law, as described in Title 21 of the Code of Federal Regulations, the FDA provides a process for individuals and community organizations to request health policy changes by submitting a citizen petition. While the phrase “citizen petition” may sound like a way for the average “Citizen Joe” to suggest ways to improve or change the way the FDA works, the reality is a bit different in practice.
Increasingly, a citizen petition is a mechanism that “Big Pharma” uses to hedge their bets and protect their commercial interests. They focus on building a fence around the privileges they gain on branded drugs in their early years after approval by the FDA.
Healthcare-brew.com offers a great article on this subject. I will summarize in my own words below.
Before getting into the nuts and bolts, a short explanation of the original intention behind the FDA regulations allowing citizen petitions is in order. This will allow us to understand better how this is being used by big businesses to bend the rules in their favor.
A deep dive into citizen petitions.
Under Title 21, citizens can submit petitions to the FDA requesting the agency to take specific actions, including issuing, amending, or revoking a rule. It is a tool meant to foster public involvement in the regulatory process. However, the terminology may be somewhat misleading since “citizen” is not restricted to individuals or groups of people but has the broader meaning of individuals and entities, including drug companies. A petition must clearly describe the requested action and provide factual and legal grounds for the request. On the face of it, its use should be that someone trying to impact health policies can assemble a campaign via a valid petition to achieve a favorable result. The FDA mandates no specific number of individuals to submit a citizen petition. However, a large and diverse group can provide more credibility – substantial numbers can be persuasive. The quality and diversity of the group are also vital. In practice, the likelihood of a successful petition depends on many other factors. Having the petitioners include medical professionals who can provide expert insight and with recognized experts in the relevant field and utilizing legal professionals familiar with health laws and advocates and activists with a track record in health policy or related areas will boost the chances of success. Already, this is making the availability of citizen petitions to the man in the street much more complicated. Then, the more sophisticated tools, such as engaging with advanced public relations professionals and with the media, help improve the likelihood of successful outcomes, but this comes at a substantial cost. It’s even possible to engage with elected officials or hired lobbyists, which can be especially effective when trying to influence official policy. What this comes down to is that while nothing stops a single individual or a small group of ordinary people from utilizing the process of citizen petitions, there’s a better chance of influencing health policy changes if money and expertise are heavily invested in the process.How Big Pharma Can Use the Citizen Petitions Process
Over many years, several brand-name drug manufacturers have used the citizen petition process as a strategic tool to delay or defer the approval of generic drug applications. By filing a citizen petition, brand-name manufacturers can raise concerns or questions about a pending generic application, requiring the FDA to address those concerns before approving the generic drug. There are many different ways in which drug companies can use the Citizen Petitions process to protect themselves against generic versions:- Petitions can express concerns about the safety and efficacy of a generic counterpart.
- Brand-name companies can challenge the FDA’s methods for determining that the generic version works in the same manner as the branded drug (bioequivalence).
- Branded drug companies might file a petition questioning the studies the generic company used in its application.
