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With deep experience in FDA regulatory law and health policy consulting, we advise patient advocates, global life science and innovative emerging companies on product approvals and regulatory reforms, drafting and enacting Federal legislation, and securing funding or creating new P3s...
About Us
Find Your Policy Solutions
Find Your Policy Solutions
Find Your Policy Solutions
Since 2002, we've collaboratively developed creative life science, FDA and public health solutions for Fortune 100 and emerging companies, coalitions, and patient groups.
About Paul
Find Your Policy Solutions
Find Your Policy Solutions
Offering over 35 years of Federal health
policy and legislative insights, as former congressional committee staff, policy advisor, and leader of national FDA law and Federal affairs practices
What's New?
Find Your Policy Solutions
What's New?
See our views and opinions on the latest health policy developments - from disruptions in Federal funding and regulation, orphan drugs and expedited drug reviews, to regulating gene editing and AI/ML...
Find your policy solutions here
Latest Views
Read the Milbank Quarterly essays on FDA in the Trump Administration or the Orphan Drug Act, the Health Affairs Forefront essays on HHS Secretary Kennedy and vaccines or mifepristone, or my quotes in the Financial TImes, AP, and trade press.
Federal Experience
Keep up with FDA's changing regulatory priorities. Develop policy solutions and effective engagement strategies for FDA, HHS, NIH, CDC, ARPA-H and BARDA.
Diverse Clients
Nonpartisan Expertise
Our clients have included Fortune 500 and innovative early stage biopharmas, leading patient groups, coalitions, life science trade associations, and innovators in Europe, South Korea and Israel.
Nonpartisan Expertise
Nonpartisan Expertise
Our solutions are grounded in sound policy, a clear understanding of the law, and the best clinical evidence - helping advance public health for all.
Trusted Collaborators
Trusted Collaborators
If you need to work with CMS, secure a Federal contract, or lobby Congress, our trusted consulting partners are established experts in their domains.
Just Have a Question?
Trusted Collaborators
Feel free to call or message with your health policy question. Let's discuss the issue and find some new approaches...