Report: FDA officials opposed drug suit policy
Lawyer Blogs
Top scientists and career employees at the Food and Drug Administration opposed agency regulations that weaken consumers' ability to sue drug makers, congressional investigators said Wednesday.
At issue is language in a drug labeling rule from 2006 that effectively limits when people can sue in state court over injury claims involving medications. The FDA contends federal regulations prevail when there is a conflict with state law. This concept is called pre-emption.
Internal agency documents showed that career officials opposed this approach, according to a report released by Rep. Henry Waxman, chairman of the House Oversight and Government Reform Committee. In the past, the agency had viewed private suits as an additional layer of protection against unsafe drugs, the report said.
"Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis," the report quoted Dr. John Jenkins, who oversees FDA's new drug reviews, as saying. "We know that such an assumption is false."
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Is Now the Time to Really Call a Special Education Lawyer?
IDEA, FAPE, CHILD FIND and IEPs: The Individuals with Disabilities Education Act (IDEA) guarantees all children with disabilities to a free appropriate public education (FAPE). FAPE starts with a school’s responsibility to identify that a child has a disability (Child Find) and create an Individualized Education Program (IEP) to suit the needs of the child.
Forte Law Group is one of only a very few law firms within the state of Connecticut that is dedicated to exclusively representing families and children with special needs.
Parents need to be persistent, dedicated and above all else aware of the many services and accommodations that their child is entitled to under the law. As early as this point within your child’s special education, many parents will often find themselves in the situation asking, “is now the time to really call a special education lawyer?” Here are a few things to consider when asking yourself that question.