Shifting Trends In Marketing Approvals Of Orphan Drugs

Law360 (June 3, 2021, 6:26 PM EDT) -- After stalling the week prior, the U.S. House of Representatives passed the Fairness in Orphan Drug Exclusivity Act on May 19 with an overwhelming majority.

The legislation would amend the Orphan Drug Act by "requiring all drugs that secure seven years of market exclusivity to provide proof that they don't expect to recoup the costs of research and development through sales of a drug."[1]

According to Rep. Madeleine Dean, D-Pa., the bill's primary author, the legislation would close a loophole and "eliminate barriers for innovative medication assisted treatments (MAT) to come to market, boost competition in the marketplace, and drive down...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


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!