MONDAY, March 21 (HealthDay News) -- Four physicians have formed a company to reintroduce a penicillin allergy skin test to the U.S. market.
The company, AllerQuest, hopes to have the test back on the market within a year, although the timing would be contingent upon U.S. Food and Drug Administration approval.
The initiative was announced Monday at the annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI) in San Antonio.
"After being off the market for a number of months, it looks like we can see a clear path forward," Dr. Michael Schatz, immediate past president of the AAAAI, said at a news conference. The AAAAI has been working for the past 18 months to facilitate this deal, he added.
"We essentially practice medicine now like we did in 1973," added Dr. Eric Macy, chairman of the AAAAI's adverse reactions to drugs and biologics committee. "Allergists have been clamoring for this test, and so the academy has been clamoring for it."
Some 10 percent of Americans, 30 million people, have a history of penicillin allergy. Many of these people later test negative to allergy for the antibiotic, however.
The skin test, available commercially since 1974, was able to tell which people with a prior history of penicillin allergy could now safely take the drug.
In September 2003, however, the test was removed from the market after the FDA ruled that companies engaged in the manufacture of penicillin-based products had to have facilities dedicated exclusively to these products because the compound can easily aerosolize into the air and contaminate other products.
The test had been made by the same company, Hollister-Stier, of Spokane, Wash., for 30 years. But the company didn't have facilities dedicated to penicillin products.
"Although we are a pharmaceutical manufacturer, we cannot handle penicillin-based products," said Derek Constable, director of development for Hollister-Stier.
Macy said: "We have these relatively simple small molecules, which are cheap and easy to make, and a complex regulatory system that makes it difficult to bring to market -- and an economic system that doesn't support it. This is a classic orphan drug case, but about 10 percent of the population is affected."
The disappearance of the skin test has had both individual and public health consequences, experts said.
"Penicillins are widely used antibiotics," Macy explained. "If you carry a history of penicillin allergy and we don't have a skin allergy test, we will not be able to treat you effectively."
The alternative is to use other antibiotics which, Schatz said, "are almost invariably more expensive or more broad spectrum, which contributes to the public health problem of antibiotic resistance."
Dr. Franklin Adkinson Jr., a founding member of AllerQuest, said, "Penicillin is not a single drug. There are many penicillins which are not available to a large number of patients because of a history of prior adverse events.
"We're concerned about not being able to serve our patients as well as we have in the past," he added.
AllerQuest has been able to contract with a manufacturer, Hanford Pharmaceuticals, of Syracuse, N.Y., which has dedicated penicillin facilities to manufacture the test. Hollister-Stier is providing the necessary licenses and know-how to AllerQuest, said Dr. Louis Mendelson, president and CEO of the new company. A portion of the company's profits have been pledged to the academy's Educational and Research Trust.
The need for such a test extends beyond the United States -- there are no commercially available tests anywhere in the world right now, Mendelson said. AllerQuest would eventually look at marketing the test outside the country, he added.
For more on drug allergies, visit the AAAAI.