Results

Policy Directions is proud of the results we deliver to our clients. Examples of some of our successes appear below.

On Capitol Hill

Working with Federal Agencies

Raising Awareness

 

• Interceded with the FDA when the agency failed to provide final approval for our client's product because it had granted orphan drug status for a similar product developed by another company. Our client's product was approved.
• Successfully assisted FDA and USDA on safety risk assessments for biotech processes, including managing industry reaction and press.
• Secured key witnesses to testify before an FDA advisory committee in support of a product that had originally been rejected; the product was later approved.
• Worked with Congress to encourage FDA to implement its own enforcement regulations by banning unapproved drugs, resulting in a clear path for our client to market their approved product.