WASHINGTON IN BRIEF
WASHINGTON IN BRIEF
TOOLBOX   Resize
 Save/Share +
COMMENT
 Discussion Policy
 CLOSE
Comments that include profanity or personal attacks or other inappropriate comments or material will be removed from the site. Additionally, entries that are unsigned or contain "signatures" by someone other than the actual author will be removed. Finally, we will take steps to block users who violate any of our posting standards, terms of use or privacy policies or any other policies governing this site. Please review the full rules governing commentaries and discussions. You are fully responsible for the content that you post.
|
Lawmakers Push for Drug Facility Inspection
Two House lawmakers threatened yesterday to push forward legislation blocking the sale of medications if the plants where they were produced have not been inspected by U.S. regulators.
Michigan Democrats John D. Dingell and Bart Stupak said they are concerned the Food and Drug Administration may have discarded a policy of inspecting facilities before products are marketed. They cited the FDA's failure to inspect a Chinese plant that makes an ingredient in the blood thinner heparin; the drug, made by Baxter International, has been tied to four deaths and hundreds of allergic reactions.
Regulators said the plant was not inspected because the agency mixed up records on the facility and another with a similar name. The FDA is not sure whether the ingredient in heparin caused the side effects.
"These heparin tragedies are likely the result of FDA abandoning its pre-approval inspection requirement," Dingell, chairman of the House Energy and Commerce Committee, said in a statement. "Since it appears that FDA feels free to ignore this long-standing policy, we are now considering whether such safeguard should be codified into law."
Dingell and Stupak also asked Baxter International to provide records about its manufacture of heparin.
Gray Wolves Losing 'Endangered' Label
The Interior Department will remove gray wolves in the Northern Rockies from the endangered species list, saying that a 13-year restoration effort helped the animal's population soar.
An estimated 1,500 wolves now roam Idaho, Montana and Wyoming. That represents a dramatic turnaround for a predator that was largely exterminated in the United States in the early 20th century.
"We're confident the wolf has a secure future in the Northern Rocky Mountains," Interior Assistant Secretary Lyle Laverty said in a statement.
The loss of federal protection allows the three states to move forward with plans allowing hunters to target the animals, possibly as soon as this fall.
Environmental groups said they will sue the federal government to keep the animal listed, saying that the species has not fully recovered.
Flu Vaccine to Get Overhaul for Next Year
Next year's flu vaccine is on track for a complete overhaul to provide protection against three new strains -- hopefully better protection than this year's version.
Federal health advisers have unanimously recommended the new recipe, echoing the World Health Organization.
