FDA puts up its Dukes

  • by: |
  • 09/15/2015

President Obama has made the most important healthcare decision of his administration. (No, not that.)

The nomination of Rob Califf to be the next Commissioner of the FDA signals the beginning of a new era at the agency that regulates more than a quarter of the US economy. Welcome to the era of entrepreneurial regulation.

Entrepreneurial Regulation means that the FDA can be both regulator of industry and its colleague in innovation. Expedited pathways are Entrepreneurial Regulation. Breakthrough Designation is Entrepreneurial Regulation. The Super Office of Pharmaceutical Quality is Entrepreneurial Regulation. More aggressive use of the Reagan/Udall Foundation is Entrepreneurial Regulation. Patient Focused Drug Development is Entrepreneurial Regulation.

It’s more than time for the FDA to take its place in the center of the healthcare ecosystem.

There are many issues facing the FDA and not just in drugs. Food safety, device reform, dietary supplement regulation. It's a long list. Califf knows the issues and the players -- most importantly those inside the agency. His nomination is both timely and savvy -- particularly with PDUFA reauthorization under way.

Califf’s nomination is an n-of-1 opportunity. When considering who could replace Peggy Hamburg, Rob Califf was the short list.

Put up your Dukes? In more ways than one.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog