The recent meningitis outbreak that has sickened nearly 500 people and killed 34 might have been prevented if it weren't for oversight failures by the Food and Drug Administration, according to The New York Times.
In documents released following Freedom of Information Act request, it was found that the F.D.A. continuously backed away from threats against the New England Compounding Center - which manufactured the tainted drugs - even when the Center refused to provide records, citing lack of jurisdiction. In some cases, the agency would issue a warning nearly 2 years after an inspection of the facility had been made.
Perhaps most troubling is the fact that the F.D.A. was alerted of a possible contamination of the drug involved in the meningitis outbreak as far back as October 2002, but the Center continued to ship the drug in defiance of the agency's concerns.
As stated in the article, "By law, compounding pharmacies are regulated primarily by the states, but the pharmacies have grown over the years into major suppliers of some of the country's biggest hospitals. The F.D.A. is asking Congress for stronger, clearer authority to police them...." Read the complete details here:
Oversight Failures Documented in Meningitis Outbreak
Steve Crandall, a top-rated medical malpractice attorney throughout Ohio and Kentucky, believes this new information displays the very disturbing nature of an agency like the F.D.A. taking shortcuts that end up harming the public it was created to protect.
If you or a loved one have been injured by a manufactured product, drug, medical device or medical malpractice leading to wrongful death or other injury, you should consult a qualified attorney to protect your rights.
In documents released following Freedom of Information Act request, it was found that the F.D.A. continuously backed away from threats against the New England Compounding Center - which manufactured the tainted drugs - even when the Center refused to provide records, citing lack of jurisdiction. In some cases, the agency would issue a warning nearly 2 years after an inspection of the facility had been made.
Perhaps most troubling is the fact that the F.D.A. was alerted of a possible contamination of the drug involved in the meningitis outbreak as far back as October 2002, but the Center continued to ship the drug in defiance of the agency's concerns.
As stated in the article, "By law, compounding pharmacies are regulated primarily by the states, but the pharmacies have grown over the years into major suppliers of some of the country's biggest hospitals. The F.D.A. is asking Congress for stronger, clearer authority to police them...." Read the complete details here:
Oversight Failures Documented in Meningitis Outbreak
Steve Crandall, a top-rated medical malpractice attorney throughout Ohio and Kentucky, believes this new information displays the very disturbing nature of an agency like the F.D.A. taking shortcuts that end up harming the public it was created to protect.
If you or a loved one have been injured by a manufactured product, drug, medical device or medical malpractice leading to wrongful death or other injury, you should consult a qualified attorney to protect your rights.
The lawyers of CMPW are available to help answer your questions and guide you in determining your next steps.