Flonase, made by GlaxoSmithKline (GSK), is an inhaled corticosteroid drug that is prescribed to relieve seasonal or year-round allergies, as well as non-allergic nasal symptoms like sneezing, itching, and stuffy or runny nose.
Flonase works by reducing inflammation inside nasal passages. It is used to manage symptoms like sinus pressure and pain. Generally, it takes a few days for patients to experience relief, and in some cases relief can take up to two weeks.
In 2006, the FDA approved a generic version of Flonase called Fluticasone, which is made by Roxane Laboratories of Ohio.
GlaxoSmithKline recently settled a court case alleging that it maintained a monopoly on Flonase by restricting the access of drug wholesalers to the generic version. A few days after the settlement, a federal judge also approved a $35 million settlement between GSK and indirect purchasers, including consumers.
The $150 Million Settlement with Direct Purchasers
In the suit brought by direct purchasers AmerisourceBergen, McKesson, and Cardinal Health, the plaintiffs claimed that GSK abused the FDA citizen petition process to block access to generic alternatives and overcharge for its product. In the settlement, GSK said that although it believes it is not at fault, settlement was in its best interests to avoid further “expense, inconvenience, uncertainties of, and risks and delays associated with, the outcome of GSK’s pending motions and/or a trial and any subsequent appeals, and the distraction of burdensome and protracted litigation.”
The $35 Million Settlement with Indirect Purchasers
Shortly after approving the settlement between GSK and the direct purchasers, U.S. District Senior Judge Anita B. Brody of the Eastern District of Pennsylvania approved a $35 million settlement with indirect purchasers. Plaintiffs in that case were:
- A.F. of L.-A.G.C. Building Trades Welfare Plan
- IBEW-NECA Local 505 Health & Welfare Plan
- Painters District Council No. 30 Health & Welfare Fund
- Andrea Kehoe
Plaintiffs alleged that GSK filed “sham” citizen petitions with the FDA in an attempt to delay entry of generics onto the market, with the result being that indirect purchasers were overcharged.
If You Think You Qualify as Part of the Class Action
The settlement class covers those who purchased Flonase or generic equivalents from May 19, 2004 to March 31, 2009. Eligibility for a share in the settlement requires that the consumer either paid for the drug out of pocket in its entirety, or paid for part of the cost of the drug due to a co-pay or deductible requirement.
If you believe you qualify, you have to provide a receipt, cancelled check, credit card statement, insurance company Explanation of Benefits (EOB), or pharmacy records as proof.
Unfortunately, finding proof of purchases made several years ago is difficult, so many qualifying consumers may be unable to share in the settlement. According to the website Class Action Rebates, a “guesstimate” rebate amount for consumers may only be around $5 anyway. Claims can be filed online, and the filing deadline is August 15, 2013.
What Does the Flonase Settlement Mean for Consumers?
The Flonase settlement may not mean much for consumers, but the Antitrust Health Care Chronicle January 2012 issue states that more challenges like the ones brought against GSK may be in the future. The tide may be turning against branded drug companies which seek to delay entry of generics by using the citizen petition process. Furthermore, future claims brought under antitrust laws concerning the citizen petition process may be more likely to survive motions to dismiss by the branded drug companies.
Often filed as the generic entry into the marketplace approaches, citizen petitions filed by branded drug companies often successfully delay final generic approval while the FDA evaluates whether the citizen petition arguments have merit. While there is hope that the tide may be turning more in favor of consumers, it won’t happen overnight, because challenges like the ones against GSK can take years to proceed through the courts.
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