DrugWonks on Twitter

DrugWonks on Facebook

CMPI Videos


Video Montage of Third Annual Odyssey Awards Gala Featuring Governor Mitch Daniels, Montel Williams, Dr. Paul Offit and CMPI president Peter Pitts


Indiana Governor Mitch Daniels


Montel Williams, Emmy Award-Winning Talk Show Host


Paul Offit, M.D., Chief of the Division of Infectious Diseases and the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, for Leadership in Transformational Medicine


CMPI president Peter J. Pitts


CMPI Web Video: "Science or Celebrity"

Social Networks



Please Follow the Drugwonks Blog on Facebook, Twitter, LinkedIn, YouTube & RSS




Add This Blog to my Technorati Favorites
Political Blogs - BlogCatalog Blog Directory

Tabloid Medicine

Please Check out the latest book by
Dr. Robert Goldberg Ph.D.
"Tabloid Medicine"

Check Out CMPI's Book

Physician Disempowerment:
A Transatlantic Malaise

Edited By: Peter J. Pitts
Download the E-Book Version
Here

CMPI Events

Donate

CMPI Reports

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
 


PDUFA POLITICS: GENERIC SEEK PROFITS AND FORSAKE SAFETY

Fri, Jun 15, 2012 | Dr. Robert Goldberg
The passage of the Prescription Drug User Fee Act (PDUFA) has stalled.   The generic drug industry, along with AARP, trade unions and some other organizations support a provision that they claim would simply require " brand-name drugmakers to provide samples of their medicines, including biologics. Generic drugmakers and their allies, including some insurers and pharmacy benefit managers, complain that brand-name drugmakers have been using the strict distribution provisions of the Risk Evaluation and Mitigation Strategies ( REMS) regulation as an excuse not to provide samples for development and testing."  

And the generic industy says that as a result drug companies are costing consumers and taxpayers billions.

That's the spin.   It's not about the samples.   It's about getting around REMS.  Generic companies never guarantee that they will replicate the REMS system that an innovator comany uses.    Anyone who has seen the citizen's petitions of the generic companies knows that.   So does the FDA.   Take the the case of Accutane (the acne drug that goes by the generic name of isotretinoin):  Despite a  program designed to limit fetal damage from the drug called iPLEDGE there were 122 pregnancies just in its first year.   And that was with just one program. 

By allowing "samples"  the provision would force FDA to approval countless versions of REMS programs that were designed for a single drug for a single use for a specific group of patients.   And now, because the Supreme ruled that innovator companies are liable for harms done to patients by the administration of a generic version of their drug  (Wyeth v. Levine)   any screw up because of a sloppy REMS or the purchase of a product outside the REMS or even an adverse event could be ground for suing an innovator.  

Finally,  it's not just giving samples.  Especially when it comes to the little things, like say, permanent birth defects, maybe we want to be a bit more careful.  Perhaps we want to be extra cautious about passing around samples without having a good reason to go outside a tightly controlled method of distributing and administering a specific group of drugs that has protected infants from damage up till now?   REMS are not one size fits all to be sure.  But take a look at this video about the effects of thalidomide before assuming that there's no risk in giving generic companies every sample of every drug they want.   I find it ironic that the same interests who demand more regulation of innovator companies for the sake of safety are willing to let safety slide for the sake of generic industry profits... 


http://www.youtube.com/watch?v=FK-RuOqdZ1M