Shire says it is removing its low-blood pressure drug ProAmatine from the market, as it isn't profitable enough to justify the additional clinical tests that the FDA is requiring to stay on the market.
The company maintains in a statement that it conducted and completed the post-marketing trials that the FDA required. However, the agency viewed these trials as inconclusive and required that additional trials be conducted. As a result, Shire has elected to withdraw the product as of Sept. 30.
The FDA approved ProAmatine in 1996 under the agency's accelerated-approval mechanism. This allows drugs to be approved on clinical data suggesting benefit but requires follow up studies. Generic versions sold by Mylan Pharmaceuticals, Impax Laboratories, Sandoz, Apotex and Upsher-Smith Laboratories are also on the market.
Last year, the GAO mentioned ProAmatine when it scolded FDA for failing to follow up on drugs approved on the fast track. Since then, the agency wrote to Shire and the generics makers, requesting two studies to confirm the drugs' benefits. But no studies materialized, the FDA says.
A Shire spokesman tells the Wall Street Journal that clinical trials cost on average some $25 million. ProAmatine generated less than 0.1 percent of Shire's overall revenues last year, so it just wasn't worth the cost.
Shire acquired ProAmatine as a part of the acquisition of Roberts Pharma in 1999.
- see Shire's statement
- check out the WSJ's coverage