Hamburg to Alexander -- "Don't Rag on the FDA"

  • by: |
  • 03/11/2015

Departing FDA Commissioner Peggy Hamburg isn’t going to take “blame the FDA” as an excuse any more.

Bravo.

According to a report in BioCentury, Senator Lamar Alexander (R/TN) is leading the Senate down a narrower, slower path to 21st Century Cures legislation than the House is taking. Speaking at a hearing to launch legislation intended as a companion to the House Energy & Commerce Committee’s 21st Century Cures initiative, Alexander asked FDA Commissioner Margaret Hamburg to identify two or three top priorities for legislation and said he didn’t want to “waste time” discussing a large number of ideas. The focus on a slim bill is a stark contrast to the 393-page discussion draft of 21st Century Cures legislation released by the Energy & Commerce Committee.

Responding to Alexander’s request for top legislative priorities, Hamburg called for greater investment in “regulatory science to develop the knowledge, tools and strategies that allow us to assess in an efficient way the safety, efficacy and performance of medical products.”
Taking aim at a white paper Alexander and Senator Richard Burr (R/NC) released in January outlining the committee's goals for legislation to promote medical innovation, Hamburg argued against assuming that "FDA regulation is the principal obstacle to the development of innovative treatments, and that FDA’s authorities and procedures should be fundamentally reconsidered." She also cautioned "against solutions that seek to lower the safety and effectiveness standards for approval of the medical products on which Americans rely."

Like Gogol says, "It is no use to blame the looking glass if your face is awry."

“Blame the FDA” is a simplistic view of a complex problem. Unfortunately, it’s a sure-fire media sound-bite and it removes all responsibility for correcting many important problems from everyone else. How convenient. It’s time to grow up.

The reality is that FDA is at the center of the “21st century cures” innovation ecosystem. So rather than continuing to listen to the facile and ignorant drumbeat of “FDA as the problem,” emanating from certain quarters, groups ranging from the pharmaceutical industry, to patients groups, forward-thinking members of Congress, academia, and healthcare practitioners are beginning to realize (some faster than others) that FDA is a crucial partner – indeed a senior partner in advancing the public health.

Blame the FDA? The fault, dear Brutus …

PDUFA VI anyone?

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