How Drug Cos. Can Minimize Risks Of 'Right To Try' Laws

Law360, New York (June 30, 2015, 12:02 PM EDT) -- Drug and biologic developers have faced increasing pressure from patients and their advocates to make investigational drugs available for compassionate use prior to approval by the U.S. Food and Drug Administration. Over the past year social media campaigns have spotlighted patients seeking early access to potentially life-saving treatments, drawing attention to the growing debate between patient advocates promoting wider access to investigational drugs and those urging more cautious approaches. Propelled by the plight of critically ill patients desperately seeking new treatments, several states have passed laws giving patients the "right to try" investigational drugs or biologics. The FDA has also taken steps to make its "expanded access" process more user-friendly and the agency continues to solicit input from patient groups on risk-benefit analysis and available treatments as part of its Patient-Focused Drug Development Initiative....

Law360 is on it, so you are, too.

A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence. Over 200 articles are published daily across more than 60 topics, industries, practice areas and jurisdictions.


A Law360 subscription includes features such as

  • Daily newsletters
  • Expert analysis
  • Mobile app
  • Advanced search
  • Judge information
  • Real-time alerts
  • 450K+ searchable archived articles

And more!

Experience Law360 today with a free 7-day trial.

Start Free Trial

Already a subscriber? Click here to login

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!