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.
While these concerns can be genuine, they can also serve as a tool to delay the generic drug’s market entry.
What is the FDA’s stance on the potential misuse of a citizen petition?
The FDA has taken steps to mitigate the potential use of the citizen petition process to delay generic drug approvals and to use its functions for purely anti-competitive practices. For instance, it has to prioritize and act upon petitions within 150 days when they relate to generic drug applications. As well, the process has a reasonable degree of transparency. The FDA publishes a list of petitions on its website, including their responses to these petitions. This disclosure ensures that public stakeholders can be aware of petitions that impact their interests. The agency closely scrutinizes petitions to determine if they are submitted with the primary intention of delaying a generic drug’s market entry. It has the authority to dismiss petitions that aim solely to delay generic drug approvals without addressing genuine concerns.
Understanding branded vs generic drugs.
According to the healthcare-brew.com source article, “Generic drugs are functionally the same as brand-name drugs, but they’re cheaper to make and therefore cost consumers less.” This point needs to be emphasized. The main cost component of branded drugs is the recovery of the research, development, trial, and approval process that goes into creating new drugs. Bringing a new drug onto the market generally costs at least one to two billion dollars. On top of that, many other drugs go through the earlier stages and end up down the drain because they either didn’t work or because the FDA decided that they didn’t provide sufficiently better benefits than the drugs already approved. We have written more about this when dealing with the more common questions we tend to get about why a popular drug such as Ozempic remains so expensive.
By far the most significant element that goes into the calculation of the price of an individual dosage of a medication is the up-front expenditure that must be recovered once the drug is approved. The cost of the actual ingredients, and even the manufacturing process, is minuscule. If it gets to the stage where a competing generic version of a branded drug reaches the market, the manufacturer of the branded version should be able to manufacture the drug for far less than any new entry into the same area because the cost of plant and equipment needed to produce the drugs would have already been amortized throughout exclusivity. In contrast, the generic drug manufacturer must still set up and pay for the necessary facilities.
Are there any specific examples of how the petition process has been used to delay the approval of generic drug applications?
Here are a few instances of petitions to the FDA that were ruled as being a strategy to delay the approval of generic competitors:
Provigil (generic modafinil) is a drug used to treat narcolepsy. The original manufacturer, Cephalon Inc., filed multiple citizen petitions against generic versions of the drug from companies in both the US and Europe, claiming concerns about the generic versions’ bioequivalence. Although the FDA eventually denied the petitions, the process resulted in delays before the generic versions could enter the market. This case raises several interesting points. Generic drugs are meant to be far cheaper than their branded equivalents. Still, in this case, the best price of the generics from US retail pharmacies (around $15 per 100mg tablet) is nearly triple that of the branded version from IsraelPharm (just under $6 per tablet). This is another reason to compare prices on our branded drugs.
Restasis (drug name: ciclosporin, generic name Cyclosporine) is a dry-eye medication. In 2017, Allergan filed a citizen petition contesting the FDA’s draft guidance for generic equivalents of the drug, raising concerns about the testing protocols used by the FDA. The FDA eventually denied the petition. In this case, the average retail price of the generics in the US ($12 per vial) is around 50% more than that of the brand from IsraelPharm ($8 per vial)
Lovenox (generic name: Enoxaparin) is an injectable low molecular-weight heparin. It is used to stop blood clots from forming within the blood vessels. Sanofi-Aventis submitted a citizen petition raising concerns about potential risks from generic drug versions. They argued that because of the drug’s complexity, standard bioequivalence testing might not ensure the safety and efficacy of generics. Although the FDA took these concerns seriously, they eventually approved generic versions, stating that the generic products had demonstrated enough similarity to the brand-name drug. Comparing US retail pricing with what IsraelPharm charges is an interesting exercise. Brand name Lovenox costs around $36 per syringe. The generic equivalent, Enoxaparin costs around $26 per syringe. IsraelPharm sells Clexane brand (it’s exactly the same drug as Lovenox, also manufactured by Sanofi-Aventis, but simply marketed under a different name here) for roughly $8 per syringe.
Concerta (generic name Methylphenidate ER) is a central nervous system (CNS) stimulant used medically to treat attention deficit hyperactivity disorder (ADHD). Janssen Pharmaceuticals also filed a citizen petition questioning the bioequivalence standards the FDA was using for generic versions of the medication. The company argued that the proposed standards might not ensure that generic versions have the same therapeutic effects as the brand-name drug. The FDA also denied the petition.
NOTE: As we explain here, IsraelPharm does not sell controlled substances as a policy. Concerta and similar medications are classified as Schedule II drugs.
It’s worth noting that while some of these petitions raised legitimate concerns about patient safety and drug efficacy, the citizen petition process has been critiqued for its potential misuse as an anti-competitive tool. In the cases mentioned above, the generic approval process often faced delays even when the petitions were eventually denied.