Feeds:
Posts
Comments

Posts Tagged ‘fda’

Pre-Emptive Strike

The April 6th edition of the New York Times reports that the Supreme Court is leaning towards a legal argument called “pre-emption” that would prevent companies from being sued for product liability once that product is deregulated by a government agency, in this case the FDA. Excerpt from article:

“For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.”

Full Article

The courts leaning this direction will have obvious ramifications in the world of GMO’s as well. Transgenic crops are regulated by a ragged, moth-eaten quilt comprised of the EPA, FDA, and USDA – with all agencies acting separately and no interdepartmental communications. Each agency, as in the case with the FDA in this Johnson & Johnson suit before the Supreme Court, depends only on REPORTED testing from the companies seeking deregulation. If Monsanto or Bayer or J&J say their evaluations are positive it gets a gold star and the product goes out to the public. Not surprising with the revolving door between government agencies, the university community, and corporations. The regulatory agencies require no independent studies. “We’ll take your word for it.”

Now, when a product turns out to have a negative ramification, for example contaminating a neighbor’s crops with transgenic pollen and making them non-marketable, the companies can say – “Hey, the government approved it. Tough luck.” Even if you believe that there are useful biotech applications in crops, what ethical person can support a zero liability approach to any product, one in which we take the word of corporations as the gold standard? We as a public deserve better than this. Or maybe we should manage other public entities in the same manner. The DOT will just ask you to sign a statement saying you read the rule book and know how to drive. And do we really need contractors to get building permits and have inspections? I mean who would really build a substandard apartment complex for low-income persons just for the money?

Have we really gone this far towards a pro-corporate, anti-public, perilous and unethical regulatory climate? Undoubtedly. Paranoia? No. How many cases do we need to read about before we recognize the FDA, EPA and USDA are not doing their job? Do we allow our local institutions to behave so poorly? We need to demand that senate and congressional representatives investigate the irresponsible behavior of our federal agencies. If the courts back the agencies with pre-emption, the only way to protect ourselves is with complete reform of the agencies. As my Sicilian grandmother used to say when I tossed my toys about the living room without concern for her tripping on them: BASTA! You make the mess – you clean it up! Now!

Read Full Post »

This just in, release from USDA on a new “event”. It once again points to the lax regulation, poor handling, and inevitable escape of transgenic products into the greater agricultural and ecological community. Here is the joint statement from APHIS, EPA, FDA:

Cindy Ragin, APHIS (301) 734-7280
Dale Kemery, EPA (202) 564-7839
Stephanie Kwisnek, FDA (301) 436-1408

USDA, EPA AND FDA STATEMENT ON GENETICALLY ENGINEERED CORN “EVENT 32”

 

February 22, 2008

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), the U.S. Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) are coordinating efforts following notification by Dow AgroSciences that the company detected extremely low levels of an unregistered genetically engineered (GE) pesticide product known as a plant-incorporated protectant (PIP) in 3 of its commercial GE hybrid corn seed lines. The unregistered product produces proteins that are identical to a registered product. USDA, EPA and FDA have concluded that there are no public health, food or feed safety concerns. Additionally, USDA and EPA have determined that the unregistered GE corn PIP poses no plant pest or environmental concerns.

The unregistered GE corn PIP, known as Event 32, was found in some Herculex®RW andHerculex®XTRA Rootworm Protection products. Seed containing low levels of the unregistered Event 32 was inadvertently sold to farmers by Dow’s affiliate Mycogen Seeds and planted in 2006 and 2007. EPA and USDA previously approved Herculex®Rootworm Protection products containing a closely related PIP, Event 22. These products are also approved for use in several foreign countries.

Through careful analysis, EPA determined that the introduced proteins produced by Event 32 are identical to those approved for Event 22, and therefore they are covered by an existing tolerance exemption (EPA food safety clearance). FDA has concluded there are no food or feed safety concerns because EPA has determined that the introduced proteins in Event 32 are safe and because corn containing Event 32 is present in food or feed, if at all, only at low levels. In addition, APHIS’ scientific analysis concluded that Event 32 poses no plant pest or environmental concerns. The 2008 U.S. corn crop will not be affected. APHIS took steps to ensure Dow recalled all affected seed that was shipped to dealers for the 2008 planting season. APHIS and EPA are coordinating on the investigation of potential violations under their respective regulatory acts.

Corn Event 32 was found at extremely low levels—approximately 3 seeds per 1,000—in affected Herculex seed products. Dow reported that in 2007 approximately 53,000 acres of the affected products were planted in the United States. Total U.S. corn acreage in 2007 was more than 93 million acres. Taking into account, the low levels of Event 32 in the Herculex seed products as well as the very small proportion of these seeds that were planted, any amount of Event 32 in harvested corn would be negligible. It is estimated that no more than 0.0002 percent (two ten– thousandths of one percent) of the 2007 corn crop may have contained Event 32.

For more information on the respective roles of USDA APHIS, EPA, and FDA in the federal regulation of GE plants, see the United States Agencies Unified Biotechnology Web site at http://usbiotechreg.nbii.gov/.

Read Full Post »