Drugmaker Settles Free Speech Dispute as FDA Agrees on Label
- Pacira reaches deal with FDA over post-surgical drug Exparel
- Label to say treatment isn't limited to any specific surgery
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U.S. regulators have backed off an attempt to limit Pacira Pharmaceuticals Inc.’s promotion of its pain drug, striking an agreement that’s likely to fan the flames of debate over free speech and drug marketing. The company’s shares climbed as much as 20 percent.
After the drugmaker filed suit citing its constitutional rights to free speech, the Food and Drug Administration agreed to let Pacira broadly promote the medication Exparel, rather than limiting its sales team to talking only about its use after bunion and hemorrhoid surgeries.