In the aftermath of GSK’s decision to drop its brand-name asthma inhaler Flovent HFA in favor of an authorized generic, Sen. Elizabeth Warren, D-Massachusetts, has accused the British drugmaker of engaging in a “shameful money grab.”
But to hear GSK tell it, the company had been planning to discontinue Flovent HFA for some time. GSK's partner, Prasco, is in charge of price-setting for the new stand-in product, GSK argues.
In a letter sent (PDF) to GSK CEO Emma Walmsley, Warren accused the company of pulling Flovent HFA and marketing its own authorized generic at an “artificially inflated price” to “avoid accountability for years of outrageous price hikes.” According to the senator, this move has made the popular asthma medication inaccessible for millions of kids right on the brink of allergy season.
In recent weeks, numerous media headlines have flagged access issues for patients raised by the switch.
Warren figures GSK’s strategy was informed by the American Rescue Plan Act, which requires drugmakers to pay rebates to Medicaid if the price increases for their therapeutics outpace the rate of inflation.
After removing Flovent HFA from the market, GSK and its partner substituted an authorized generic version with a lower list price—currently around $310—compared to the branded product’s $340. The problem, according to Warren, is that GSK previously offered “significant rebates” to insurers and pharma middlemen for Flovent HFA, meaning the net price of the brand-name drug was “well below $340.”
GSK and Prasco do not appear to be offering those same rebates for the authorized generic version of the drug, according to the senator.
Now, Warren is demanding answers to a series of questions by mid-March, including inquiries about the average list price for Flovent HFA in 2023, the average net price after discounts and how much GSK estimates it will save in 2024 by “averting the Medicaid rebate on Flovent HFA that would have been applied on January 1, 2024.”
Naturally, GSK sees things differently, though a company spokesperson said over email that the company does plan to “respond directly” to Warren.
The spokesperson explained that GSK elected to launch authorized generics for Flovent HFA and its sister product Flovent Diskus to help maintain patient access to the drug, potentially at a lower cost and “knowing that we had been planning to discontinue the branded products for some time.”
She also pointed out that GSK is aware of a potential Flovent HFA generic entering the market that “may provide patients with another option to access this medication.”
In terms of access, the spokesperson explained that GSK sells the authorized generic product to its partner Prasco, which “alone” determines the market price for that version of the drug.
“GSK has no role in any formulary conversations on behalf of Prasco and the Flovent authorized generics," the spokesperson said.
Warren and GSK’s sparring match come at a critical time for drug pricing in the U.S., thanks in large part to the introduction of the Inflation Reduction Act in 2022.
Aside from price-hike-related rebates, the law will also allow Medicare to negotiate the costs of certain drugs beginning in 2026.
Elsewhere, GSK in December removed four patents related to its inhaler products Advair, Annuity, Flovent and Ventolin from the FDA’s Orange Book following the U.S. Federal Trade Commission’s (FTC’s) recent crackdown on “improper” listings.
The FTC challenged more than 100 patents in the Orange Book, arguing the improper listings could delay generic challengers.