Published April 3, 2006
ROCKFORD (AP) - The federal government intercepted a package containing medicine shipped from England and intended for use by a 6-year-old Michigan boy with muscular dystrophy, until a congressman's office intervened.
More like this
Anessa and Scott Fehsenfeld, of Rockford, were upset about the delay but relieved that the government released the drug, Deflazacort, which is vital to the health of their son. Tyler Fehsenfeld has Duchenne, an aggressive form of muscular dystrophy.
"I'm choosing to give this drug to my son that a doctor says he needs, and my country says he can't have it," Anessa Fehsenfeld told The Grand Rapids Press for a story yesterday. "As if the diagnosis isn't bad enough, and then you have this to deal with."
Tyler is the grandson of Dan Gaydou, the newspaper's publisher.
In November, customs agents within the U.S. Department of Homeland Security began cracking down on shipments of prescription drugs from outside the United States.
Agents started intercepting packages of Deflazacort and sending letters of explanation to intended recipients, saying the drug was being confiscated because it is not approved by the U.S. Food and Drug Administration.
While Deflazacort is available in Canada and throughout Europe, the company that makes it has not sought approval from the FDA to sell it here. Some doctors and advocates for muscular dystrophy patients believe the reason is because Deflazacort is an "orphan drug," with a market too small to be profitable.
An estimated 12,000 U.S. children have Duchenne, which affects only boys.
Brenda Wong, a Cincinnati muscular dystrophy specialist, wrote the Deflazacort prescription for Tyler.
Without the drug, Duchenne patients typically lose their ability to walk between the ages of 6 and 12, said Marianne Knue, a nurse practitioner who works with Wong. Since the disease also affects the heart and breathing muscles, they often die in their teens.
"But with Deflazacort, we are finding boys are able to ambulate much longer, well into their teens," Knue said, adding that she has patients on the drug still living in their late 20s.
After a Grand Rapids Press reporter called the Washington office of U.S. Rep. Vernon Ehlers (R-Grand Rapids) a member of Ehlers' staff contacted the FDA on behalf of the Fehsenfelds.
The agency agreed to release the family's package of Deflazacort under a policy that allows people to import a small amount of a drug for personal use, as long as it does not pose a risk and is approved by a doctor.
If future shipments are accompanied by an explanation of the drug's use and a prescription, they should not be impounded, the FDA said.























