FDA delays approval of neffy, a nasal spray alternative to EpiPen

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Neffy is a nasal spray that delivers epinephrine, a hormone that can reverse the symptoms of anaphylaxis, a life-threatening allergic reaction. Neffy is intended to be an alternative to EpiPen, a device that injects epinephrine into the thigh muscle. EpiPen is the dominant product in the market, but it has faced criticism for its high price and limited availability. Neffy could offer a cheaper and more convenient option for people who suffer from severe allergies.

What happened to neffy’s approval process?

Neffy was developed by ARS Pharma, a biotechnology company based in San Diego. In May 2023, the FDA Advisory Committee voted in favor of neffy’s approval for adults and children, based on clinical trials that showed its safety and effectiveness. However, on September 20, 2023, the FDA issued a complete response letter to ARS Pharma, requesting additional studies to compare the effect of repeat doses of epinephrine administered via nasal spray versus auto-injection in people with allergic rhinitis, or hay fever. This means that neffy’s approval will be delayed by several months or even years.

FDA delays approval of neffy, a nasal spray alternative to EpiPen
FDA delays approval of neffy, a nasal spray alternative to EpiPen

Who is behind the delay and why?

One of the parties that may benefit from neffy’s delay is Viatris, the owner of Mylan Specialty, which sells EpiPen. In June 2023, Viatris filed a citizen petition with the FDA, asking the agency to reject neffy’s approval. A citizen petition is a formal request that anyone can submit to the FDA, asking it to take or refrain from taking a specific action. Viatris argued that neffy’s clinical trials did not provide enough evidence to show how neffy would perform in a real-life anaphylactic event compared to EpiPen. Viatris also claimed that neffy could pose safety risks due to its nasal delivery route and its potential for abuse or misuse.

How common are citizen petitions and what is their impact?

Citizen petitions are often used by drug companies to delay or block the entry of generic or biosimilar competitors. According to a study by Robin Feldman, a professor at University of California Law, San Francisco, citizen petitions can play a crucial role in delaying generic drugs from becoming available. The study found that between 2011 and 2015, brand-name drug companies filed 92% of all citizen petitions related to pending generic drug applications. The study also found that the FDA denied 92% of these petitions, indicating that they were mostly frivolous or invalid.

Citizen petitions can have significant consequences for public health and consumer welfare. By delaying or preventing competition, they can keep drug prices high and limit access to affordable medicines. For example, Mylan has raised the price of EpiPen by 548% since it acquired the product in 2007, making it unaffordable for many people who need it. A generic version of EpiPen was approved by the FDA in 2018, after Mylan tried to block it with a citizen petition in 2015. However, the generic EpiPen still costs about $300 per two-pack, which is much higher than the original price of $57 in 2007.

What are the possible solutions to address citizen petition abuse?

Some experts and lawmakers have proposed various reforms to curb citizen petition abuse and promote competition in the drug market. Some of these proposals include:

  • Imposing stricter standards and timelines for filing and reviewing citizen petitions
  • Allowing the FDA to reject petitions that are clearly intended to delay competition or lack scientific merit
  • Penalizing petitioners who file frivolous or misleading petitions
  • Encouraging the FTC to investigate and prosecute anticompetitive behavior by petitioners
  • Creating incentives and pathways for generic and biosimilar drug development and approval.

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