Practice Areas

Biopharmaceutical Policy and Advocacy

 

Companies are developing innovative products in new therapeutic areas while facing increasing pressure to deliver value for patients and government payers.

 

Large and small biopharmaceutical companies work with us to help assess risks and benefits of various pharmaceutical policy changes considered in Congress, the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), Health Resources and Services Administration (HRSA), and other federal agencies. We provide strategic advice and develop advocacy strategies that create value for our clients and the patients they serve. We have expertise in the following program areas:

 

  • Medicare Part D – We advise clients on proposed policy changes, political risks, and the development of large and small scale advocacy programs to preserve the benefit.

  • Part B – We help clients navigate product launches and work with outside reimbursement counsel to strategically advocate for products before CMS.

  • FDA – We have unique experience helping clients negotiate provisions in various Prescription Drug User Fee Act (PDUFA) reauthorizations and we prepare them for future user fee negotiations and accompanying legislative activity in Congress.

  • 340B – Many clients have increasing exposure in the outpatient hospital setting as the 340B program has grown. We advise clients on the political and policy landscape around the program.

 

Biodefense and Pandemic Preparedness

 

We provide clients with strategic government affairs and business counseling on Federal acquisitions and procurements, and regulatory and legislative strategy, in the field of biodefense and pandemic preparedness. 

 

Our team has played key roles in the development and enactment of every major bioterrorism and biosecurity preparedness law enacted in the past ten years. These federal programs, such as Project BioShield and the Biomedical Advanced Research and Development Authority (BARDA), are extremely complex and difficult for innovator companies to navigate. Our goal is to assist clients developing medical countermeasures – which include vaccines, antivirals, antibiotics, and diagnostics - with the process of obtaining and managing high-value biodefense product approvals and government contracts.

 

We have extensive relationships in Congress and broad experience with key federal agenices including the Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the FDA, and the Department of Defense (DOD). Through our expertise we work to simplify the process and maximize our clients' efforts. Together, our team has:

 

  • Worked with HHS, Members of Congress and staff to craft legislation strengthening the nation’s response to pandemic outbreaks and bioterrorism, including Project BioShield and BARDA.

  • Advised companies on obtaining government contracts for the advanced development of medical countermeasures including: pandemic influenza vaccines; anthrax and smallpox vaccines, and diagnostics.

  • Advised early-stage companies on obtaining government grants for preclinical development.

  • Assisted clients on medical countermeasure product filings and helped expedite the approval process.

  • Educated clients regarding government procurement and stockpiling procedures.

  • Provided strategic counsel to innovator companies in support of Congress’ passage of and reauthorization of the Pandemic and All-Hazards Preparedness Act, which created BARDA.

 

Medical Device and Diagnostics Policy and Advocacy

 

Medical device companies face different challenges than other innovative, regulated industries. We advise clients on issues before Congress, FDA, and CMS and create advocacy strategies to help them succeed in a competitive marketplace.