GlaxoSmithKline has offered to freeze the wholesale price of its Ventolin HFA inhaler as part of its case for FDA to phase out chlorofluorocarbon albuterol metered-dose inhalers by December 31, 2005.

"GSK has publicly committed to freeze the wholesale price of Ventolin HFA until 2008 at the earliest," ¹ GSK's comments on FDA's ² proposed rule state.

FDA has expressed concern that phasing out CFC-containing albuterol inhalers would create economic burdens since generics would be pulled from the market (³ Also see "Albuterol Transition To CFC-Free: Increased Cost Could Affect Patient Access" - Pink Sheet, 21 June, 2004., p. 42). The only ozone-safe products available are Ventolin HFA and Schering-Plough/3M's Proventil HFA .

In addition to the price freeze, GSK said distributing two million free samples annually and executing new and existing patient assistance programs "should mitigate the risk that access problems will lead to a decline in overall treatment of asthma and COPD (chronic obstructive pulmonary disease) due to a phase out of CFC albuterol MDIs."

The two million free samples are aimed towards sales territories which "may include lower income areas."

GSK's Bridges to Access program makes available to all eligible patients on GSK medicines the option to "obtain Ventolin HFA for a one-time $10 retail co-pay for a 60-day fill, and thereafter free of charge."

In addition, GSK will also make available at least three million $10 "Ventolin HFA Savings Checks" annually, the comments state. The company will maintain this program through at least 2009, assuming the 2005 phase-out date.

FDA estimates the potential reduction in therapies that may occur due to the price increase associated with the loss of generic competition falls within the range of 400,000 to one million MDIs per year.

GSK states the "more realistic low-end range" is approximately 100,000 and the upper range of one million is "unrealistic."

"The introduction of generic albuterol MDIs did not bring a significant improvement in health care," GSK argued, so "it would be unreasonable and speculative to conclude that a phase-out of CFC albuterol will result in a significant erosion of health care."

Retailers are telling FDA that a phase-out would affect customers. Rite Aid and the National Association of Chain Drug Store expressed concern regarding the impeding price increases.

⁴ Rite Aid's comments and ⁵ NACDS' comments both state that many asthmatic individuals are "low income or uninsured. This population is certainly not equipped to adapt to large increases in medication costs."

The comments suggest that higher drug prices may result in lower use. "Price increases force patients to make decisions concerning the importance of their medications."

In addition to economic concerns, FDA is considering capacity in weighing when to phase out CFC products.

The timing of the phase-out is something of a chicken versus egg dilemma in which FDA is hesitant to remove products without assurance that a replacement supply will be available and manufacturers are unwilling to invest in capacity without knowing there will be demand for the products.

"If the effective date is substantially beyond Dec. 31, 2005, it would serve no purpose for GSK to complete expansion of production capacity by that date only to have it sit idle for a long period of time," GSK said.

GSK and Schering-Plough have stated that a 12-18 month transition period is needed to allow for adequate ramp-up of manufacturing supply capabilities.

Both manufacturers told FDA they need a definitive date when CFCs would be phased out before they can ramp-up production of HFA inhalers (⁶ Also see "Albuterol CFC Phase-Out Date Needed Now For HFA Ramp Up, Firms Says" - Pink Sheet, 14 June, 2004., p. 38).

Regardless of FDA's decision, the climate of limited CFC production under the Montreal Protocol and the Clear Air Act may disrupt CFC supplies in the near future, Schering warned.

"Should the effort to qualify an alternate source in Schering-Plough's existing CFC-based MDI be unsuccessful, a dramatic disruption in MDI supply is not only possible, but likely, based on the market utilization," ⁷ Schering's comments state.

GSK Offers Price Freeze On Ventolin HFA In Bid For Early Phase-Out Of CFCs

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