cialis online

FDA Taps Drug Company Executives for Reagan-Udall Foundation

AddThis Social Bookmark Button

Drug company executives are allowed to serve on a new Food and Drug Administration (FDA)-related board called the Reagan-Udall Foundation.  Reagan-Udall was created as part of a major FDA overhaul signed into law this past September and authorized by Congress under Title VI of the FDA Amendments Act.  The foundation is supposed to help improve the drug approval process, but with so many scandals involving defective drugs in recent years, is it wise to give the pharmaceutical industry so much say on the Reagan-Udall board?

Does this just shriek conflict of interest?  Well, this new food and drug research foundation, which is affiliated with FDA, brings private companies into a curiously close relationship with regulators like the FDA. Serving as chairman of the Reagan-Udall board is former FDA Commissioner Mark McClellan; executives from drug makers Johnson & Johnson and Genzyme, medical device maker General Electric Company, and the Grocery Manufacturers Association, which includes Hormel Food Corporation and Kellogg Company, were among those picked to lead the Foundation.  No government officials are permitted to serve as voting members on the board of Reagan-Udall.  For the most part, Reagan-Udall will be funded with private donations.

The Foundation was designed to address a matter of real public concern—the gross inefficiencies in our drug development process—by modernizing the process of drug development and evaluation.  Interestingly, the Foundation will address these inefficiencies via collaboration among the FDA, academic research institutions, and industry.  Does the notion of collaboration between industry and FDA raises the possibility of a conflict of interest? The Congress has proposed independent oversight of the foundation; however, details have not yet been defined and four Foundation board seats are reserved for industry representatives—industries such as pharmaceutical, device, food, cosmetic, and biotech.

If better collaboration between government, industry, and academics can help fix the problem, then why not embrace this new partnership?  Well, what about the Foundation’s composition? Will this sort of internal alliance allow industry to influence regulatory policy?

Over the past decade, new drug approvals have lagged far behind the substantial increases in federal and private sector funding of biomedical research.  For instance, drug research and development spending increased 150 percent while the overall number of new drug applications for new molecular entities only increased by seven percent over the same period, even declining in recent years.  Bringing a new drug to market costs, on average, over $1B and takes 15 years.  Yet, only eight percent of cancer drugs entering Phase I of the process will receive approval.  Clearly today’s process is horribly run and leads to an untold loss of lives due to delayed or complete lack of access to new and effective therapies.

But consumer advocates and some lawmakers have criticized the relaxed partnership, stating that allowing companies to fund government-sanctioned research could increase the FDA’s vulnerability to industry clout.  They also question how the FDA will be able to objectively review products that incorporate its own research and if this new collaboration will open potential for pressure on the FDA.  Under the law creating Reagan-Udall, the board’s first task will be to draft guidelines for how the foundation will operate, including the collection and distribution of funding—the board is tasked with awarding funds to researchers in government, academia, and industry.  The board’s first meeting has not yet been scheduled.

« »

Leave a Reply

You must be logged in to post a comment.

NEWS CATEGORIES

GOVERNMENT NOTICES

ARCHIVES


Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!
defective-hip-replacement.com

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!
CAT-Scans-Radiation-Exposure.com

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.
WaterContaminationFrom Fracking.com

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to PCBs.com

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!
TallisPhoto.com

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO
Poligrip-Lawsuit.com

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!
Nassau-Personal-Injury-Lawyer-Online.com

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!
nursing-home-blog.com

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!
www.nassau-car-accident-lawyer-online.com

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!
www.suffolk-car-accident-lawyer-online.com

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!
www.veterans-benefits-denial.com

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!
www.oil-rig-spills.com

Whistle Blower

Stand up and say what you think is right. See something, say something.
whistlebloweradvisor.com