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Friday 10 March 2006

Albuterol Inhaler Market Takes Unexpected Turn

By: Cheryl A. Thompson

Bethesda — The economic analysis that federal regulators performed before declaring a Dec. 31, 2008, rather than 2005, ban on the ozone-depleting propellant in albuterol metered-dose inhalers (MDIs) was based on a critical assumption: continued availability of the generic chlorofluorocarbon-propellant products that dominate the market. That assumption, apparently, did not bear out.

Armstrong Pharmaceuticals and IVAX Pharmaceuticals—two of the three makers of generic albuterol MDIs—have been releasing the products to the market at uneven or almost-negligible rates since at least late December 2005, said Erin Fox, a University of Utah pharmacist who provides information for the ASHP Drug Product Shortages Management Resource Center. The third company, Warrick Pharmaceuticals, the generics subsidiary of Schering-Plough Corp., has been performing at a fairly consistent level, she said.

Yesterday, the Food and Drug Administration (FDA) acknowledged that there have been "temporary outages" of albuterol MDIs from some manufacturers since early January. But with other manufacturers producing "at previous or increased levels," FDA stated without identifying whom, albuterol MDIs overall "continue to be available and additional supplies are anticipated over the next several weeks."

In originally announcing the Dec. 31, 2008, date last April, FDA had said that the extra three years was needed to ensure that the makers of hydrofluoroalkane (HFA)-propellant albuterol MDIs could meet the 50-million-unit-a-year demand for albuterol MDIs, which treat acute episodes of bronchospasm.

Retail prices for the HFA-propellant albuterol MDIs run about the same as for the brand-name chlorofluorocarbon-propellant products but $25 or so more than the generic products, according to information FDA received from IMS Health in 2004. FDA did not expect generic HFA-propellant albuterol MDIs to be available much before 2016.

Jennifer Reddan, manager of the drug information service at Clarian Health Partners, a three-hospital, 1400-bed health system in central Indiana, said the pharmacies' inventory of albuterol MDIs has never looked worse.

ne of the hospitals has less than a dozen units in the pharmacy, she said Tuesday, and the health system's primary drug wholesaler had just told her that all albuterol MDIs, even the brand-name products, were on back order. The health system is considering using levalbuterol MDIs if it cannot obtain more albuterol MDIs, she said.

Pharmacy professor Leslie Hendeles said that Shands Hospital at the University of Florida in Gainesville has been using Proventil HFA, from Schering-Plough, when unable to obtain generic albuterol MDIs. He said the price difference has not affected efforts to convert more recipients of nebulizer therapy to an albuterol MDI and a valved holding chamber.

Doing the reverse—substituting an MDI with albuterol nebulizer treatments— is not a feasible option at Clarian, Reddan said, because the respiratory therapy department is already short-staffed.

At Cardinal Health, spokesman Jim Mazzola said the wholesale distributor nowadays obtains albuterol MDIs from Armstrong and Warrick but previously also bought from IVAX.

Armstrong and Warrick, Mazzola said, have been allocating their products to Cardinal.

"Whatever manufacturers have allocated to us, we then have to allocate to our customers," he said, adding that Cardinal has been receiving about 90 percent of the albuterol MDIs that the company would have normally.

Pharmacist Terrence Eck, a pharmacy contract director at Consorta, a group purchasing organization based in Chicago, on Tuesday said only one of 360 hospitals had reported a problem obtaining albuterol MDIs. "I can't explain," he said. "They may have stocked up pretty well."

Generic chlorofluorocarbon-propellant albuterol MDIs, according to IMS Health data supplied to the FDA, captured about 96 percent of the retail market for albuterol inhalers in 2004.

Based on FDA's analysis of IMS data, hospitals and other purchasers outside "retail channels" annually buy about 5 million albuterol MDIs, accounting for 10 percent of the total market.

Accustomed to a tiny share of the market, makers of the brand-name albuterol MDIs, including HFA-propellant products, were unprepared to quickly increase production.

Schering-Plough recently told contractor 3M Co., the actual manufacturer, to make more Proventil HFA, said spokeswoman Julie Lux. Her company did this and increased Warrick's production of chlorofluorocarbon-propellant albuterol MDIs to "full capacity", she said, after hearing that the other makers of chlorofluorocarbon-propellant albuterol MDIs were exiting the market "ahead of schedule."

Lux said her company's earlier statement to FDA about greatly boosting production of Proventil HFA by the end of 2005 was based on the agency's initial proposal to ban chlorofluorocarbon-propellant albuterol MDIs on Dec. 31, 2005.

Schering-Plough had reserved the right to "adjust the timing of the ramp-up of manufacturing capabilities" if FDA instituted the ban "significantly later than December 2005," according to an August 2004 letter to the agency. In that letter, the company warned that MDI manufacturers could not count on future supplies of chlorofluorocarbons, now that most of the world's developed countries were banning production or stopping the use of the ozone-depleting propellant.

GlaxoSmithKline in August 2004 had told FDA that the company would expand its Ventolin HFA manufacturing facility and produce 30 million units annually if FDA committed to the Dec. 31, 2005, date. But if FDA "substantially" moved the date for chlorofluorocarbon-propellant albuterol MDIs to leave the market, "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."

A March 2004 letter from the company stated that the manufacturing facility was operating at 2.5 percent of its then 20-million-unit-a-year capacity, equivalent to 500,000 Ventolin HFA units a year.

GlaxoSmithKline did not respond to requests to state the company's current level of production.

But an operator in the customer response center said that, according to a March 8 memo, GlaxoSmithKline had about 100,000 Ventolin HFA units available for shipment and, to date, had shipped roughly 60,000. Twelve wholesale distributors, including AmerisourceBergen and McKesson, were the recipients.

An IVAX customer service representative on Wednesday said the company plant in Ireland was still making chlorofluorocarbon-propellant albuterol MDIs.

That same plant also makes IVAX Laboratories' Proair HFA, a brand-name product that entered the U.S. market in late 2004 and is not considered by FDA to have therapeutic equivalence with other albuterol MDIs.

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