It's not just human drug safety that gets Sen. Chuck Grassley into letter-writing mode. When the FDA decided to let a reformulated version of a Wyeth heartworm drug for dogs back onto the market, Grassley fired off a missive to Commissioner Andrew von Eschenbach. What he's worried about is: a. whether the new formula was actually tested on dogs (he alleges the tests were only done on guinea pigs), and b. whether any of the agency meetings about putting the drug, ProHeart, back up for sale involved FDA safety officials. Considering the way people reacted to the big pet food recall last spring, Grassley's vigilance on behalf of U.S. canines could win him some friends in the dog-owner set.
The pharma set? Not so much. Grassley's letter put a safety spin on what Wyeth probably hoped would be an uneventful, but successful reintroduction of ProHeart. The company pulled the previous version of the med in 2004 after reports that 500 dogs died after taking it. Then, Congress held hearings into the FDA's handling of the drug when a staffer said she'd raised questions about its safety--but her superiors shot her down. The new formula, in fact, is coming out under a restricted-distribution program, and its label includes warnings to refrain from administering it within a month of a vaccine.
- read the CNN Money story [1]
Links:
[1] http://money.cnn.com/news/newsfeeds/articles/djf500/200806051801DOWJONESDJONLINE000879_FORTUNE5.htm