Orlando Injury Lawyers Applaud Senate's Drug Bill
In recent posts I discussed the importance of failure to warn claims in drug product liability lawsuits. As Orlando injury lawyers we reviewed the value of maintaining these state law claims and fending off federal preemption defenses in pharmaceutical injury claims. Now the U.S. Senate has made clear that the authority of the Food and Drug Administration to regulate drug approval and labeling should not be interpreted as altering existing state law.
In re-authorizing the Prescription Drug User Fee Act, the Senate included major new initiatives to enhance the FDA's authority to police drug safety. All the while no language was included which can bolster the pharmaceutical industry’s preemption argument. Indeed, as the American Association for Justice points out, during debate on the bill Senator Kennedy, the chief sponsor of the bill, emphasized that he wanted that clearly understood. As he stated on the floor of the Senate:
"We do not intend to alter existing State law duties imposed on the holder of an approved drug application to obtain and disclose information regarding drug safety hazards either before or after the drug receives FDA approval or labeling. Nor are we expressing a belief that the regulatory scheme embodied in the bill is comprehensive enough to preempt the field or every aspect of State law. FDA's approved label has always been understood to be the minimum requirement necessary for approval. In providing the FDA with new tools and enhanced authority to determine drug safety, we do not intend to convert this minimum requirement into a maximum...Nor are the bill's requirements that holders disclose certain safety information to the Government intended to substitute for the disclosure requirements that may be required under State law".
Of course, there is a long way to go before we learn what the final version of the legislation will look like. The House is not expected to consider its own version of the drug bill until later this summer. Certainly, the pharmaceutical industry will seek to favorably influence this process. We will keep an eye on this important legislation.
