Whew! Supreme Court rules generic labels must track RLD
- Posted by: Ken Phelps
- Published on: June 24, 2011
A lot of generic companies are breathing easier today. As we discussed in this blog before, two district courts ruled that generic companies must comply with state laws and add warnings to the label even if it differs from that of the brand product (the Reference Listed Drug – RLD). The cases went to the Supreme Court which ruled yesterday that since it was impossible for a generic company to comply both with the Federal FDA requirements and state laws, Federal law pre-empts state law.