Office Politics

  • by: |
  • 03/18/2013

I believe you have my stapler.

So, what of the OPDP reorg?

The article below (from FDA Week) does a good job with the particulars. Let me add to (and slightly better position) my quotes therein.

One way to look at the problem is that OPDP is under-resourced in terms of dollars, staff – and staff expertise.  True.

Another way to look at it is that the form and function of this Office needs to be reexamined. Also true.

And the answer isn’t user fees.

Sources Mixed On Impact Of FDA Drug Advertising Office Reorganization

The new structure of FDA's drug advertising compliance office -- a switch that divides up oversight by therapeutic area rather than by type of advertising -- could have mixed results, sources said following the agency's March 8 announcement of the reorganization. The more generalized approach could lead to less predictability for industry, but the change could also help focus reviewers, leading to greater efficiency and a more critical view of the data, sources said, noting the impact on enforcement actions is unclear.

Agency drug center chief Janet Woodcock said the changes will allow OPDP to more effectively review direct-to-consumer and health professional advertising by increasing efficiency, improving work distribution and eliminating redundancy, while also emphasizing the agency's commitment to providing close oversight of DTC advertising. The move comes as FDA vows to continue its tough scrutiny of off-label drug promotion despite a recent court decision that some have said could stem such oversight.

FDA announced March 8 that it is restructuring its two divisions overseeing consumer and professional drug advertising, and realigning them among various therapeutic divisions overseeing the two promotion categories.

Under the new structure, the new Division of Advertising and Promotion Review I will include four teams that will oversee consumer and professional advertising related to neurology and psychiatry; hematology; oncology; and analgesics, anesthetics and antivirals. Four teams in the new Division of Advertising and Promotion Review II will review promotion for osteoporosis, reproductive and urology; dental, dermatology, and metabolic and endocrine; allergy, gastroenterology, pulmonary and rheumatology; and anti-infective, cardiovascular, medical imaging, ophthalmology, renal and transplant.

Some sources contend the move is little more than "rearranging the furniture." Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner for external relations at FDA, said the move shows OPDP is understaffed, adding that the move spreads existing resources too thin.

"It is simply taking an under-resourced office and relocating its existing expertise," he said.

Pitts said the move could have a downside as reviewers will need to become more generalized to oversee both consumer and professional advertising. A more generalized approach could mean less predictability, he said.

"What it will do is it will further decrease the predictability and advice that office offers," Pitts said. "That is certainly not a step in the right direction."

Arnie Friede, an attorney with his own practice, said in theory, the reorganization will allow reviewers to become experts on the science related to a certain class of drugs and reduce duplication, allowing more efficient reviews over time. He added that expertise could allow reviewers to view the data with a more critical eye. A better understanding of a class of drugs could make reviewers more sensitive to analysis that industry has done or it could lead them to be more skeptical, Friede said.

"I think that time will tell whether the rationale for the changes will accomplish those things," he said. "The rationale seems, in theory, reasonable. Whether that translates into more enforcement or less enforcement over time, that is hard to know."

The latest reorganization comes after FDA, in 2011, renamed and elevated OPDP within a new super office, creating separate divisions to examine consumer drug promotion and professional drug promotion. The most recent change was prompted by a review of the workload and review processes in OPDP's two divisions to improve their overall impact and effectiveness, according to Woodcock.


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
Better Health
Biotech Blog
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
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
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
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog