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STEVEN GROSSMAN
New CBER Leadership: The FDA Matters Analysis
STEVEN GROSSMAN

The headline, “Dr. Prasad to succeed Peter Marks as CBER director,” spread like wildfire Tuesday night after Endpoints News broke the story. 

Reactions ranged from “Omigod, he’ll destroy the industry and the hope of patients” to “no big deal, staff do the product reviews regardless of who runs the Center.” Experience tells me his tenure is likely to be a little bit of both….but mostly other things that have to do with leading CBER during a time of great promise for products within its jurisdiction. 

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STEVEN GROSSMAN
STEVEN GROSSMAN
Truth-Telling: FDA User Fee Edition
STEVEN GROSSMAN

After 50 years in Washington, I have no expectation of being told the truth by government officials—elected or appointed. I like to think I have seen it all—shading the truth, burying the truth, plausibly deniable truth, and sometimes things entirely made up and called the truth.

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STEVEN GROSSMAN
STEVEN GROSSMAN
The American People in the Hands of an Indifferent Government
STEVEN GROSSMAN

Several decades ago, when I was a Senate staffer, I observed that I could spend the entire Gross Domestic Product on the good ideas that people brought to us. I soon learned that lawmaking requires a substantial amount of restraint and a lot of prioritizing. Those are hard virtues to develop and very hard to keep when you face voters every few years. 

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STEVEN GROSSMAN

IN THE PRESS

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Steven on User Fees in Roll Call Daily
Steven Grossman of FDA Matters

Steven A. Grossman, JD
President of HPS Group, LLC

Steven A. Grossman, JD, is President of HPS Group, LLC and a highly respected policy and regulatory consultant. 

In recognition of his advocacy and policy leadership, he was awarded the Reagan-Udall Foundation for the FDA’s  Innovations in Regulatory Science Award in December 2024. 

In 2006, in response to the FDA’s chronic underfunding, Mr. Grossman co-founded and later served as Executive Director of the Alliance for a Stronger FDA. This multi-stakeholder coalition has helped grow the FDA’s appropriated budget from $1.6 billion to $3.5 billion and deepened public understanding of the agency's expanding responsibilities and budget needs.

Mr. Grossman’s advocacy is rooted in public service, having spent six years as counsel and Health Staff Director on the Senate HELP Committee and four years as a Deputy Assistant Secretary for Health at HHS. 

While in the Senate, he was one of the chief Senate negotiators on the Orphan Drug Act (ODA) and the Drug Price Competition and Patent Term Restoration Act (known as  Hatch-Waxman).

While at HHS, he played a significant role in efforts to address the then-early AIDS/HIV crisis and implement the Orphan Drug Act. 

Mr. Grossman holds a BA from Oberlin College and a JD from Georgetown University Law School. 

FDA Matters is the product of HPS Group, LLC, a public affairs and regulatory consulting group. Steven Grossman, principal of the firm, is the former Executive Director of the Alliance for a Stronger FDA. Earlier in his career he was Counsel and Health Staff Director of the Senate Health, Education, Labor, and Pensions (HELP) Committee and a Deputy Assistant Secretary for Health.

This site features Steven’s current writing about FDA. It also contains his writing (2008-2012) from an earlier iteration of FDA Matters, as well as his Analysis and Commentary columns  (2009-2024) written for the Alliance for a Stronger FDA’s Friday Update. The earlier columns contain contemporary reporting and analysis of the passage of the Biologics Price Competition and Innovation Act (BPCIA).

To receive new material from Steven—including his thoughts on FDA in 2025--please sign up on the FDA Matters mailing list. Full privacy rights will be respected; your name will not be shared. Further, Steven’s emphasis will be on quality over quantity, so new columns will not overwhelm your in-box.