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This article really infuriated me because I just don't think there have been enough studies done on the effects of genetically engineered food to warrant this type of quickie approval. Shouldn't there be at least 10 years of feeding this stuff to rodents before considering approval? It is obvious the FDA does exactly what it wants to do and that there really is no logical reasoning for how they work.




Despite having an inadequate plan for addressing the serious concerns with creating genetically engineered (GE) animals, the U.S. Food and Drug Administration (FDA) moved with uncommon speed in the closing days of the Bush administration to release its final guidelines on the regulation of GE animals.



A Food and Drug Administration advisory panel has deemed a drug from a genetically engineered animal to be safe and effective even though the agency has not yet decided what the rules for such approvals should be.
By Rick Weiss | Monday, January 12th, 2009

Sometimes government agencies do the right thing and other times they get it all wrong. Then there are the times when they seem to be trying, but they blow it and they swear they?ll do better next time and you think: I don?t want to be a sucker but okay, I?m going to cut them some slack and see what they do next.

Such is the case with the Food and Drug Administration?s handling last week of the nation?s first formal application by a company to market a human medicine produced by genetically engineered farm animals?specifically, a medicine made in the udders of goats.
Weiss?s Notebook

CAP Senior Fellow Rick Weiss

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

The medicine is antithrombin III (brand name ATryn), a protein that aims to prevent blood clots in people with a rare but dangerous hereditary propensity to clot when they should not, manufactured by GTC Biotherapeutics of Massachusetts. More to the point, it is manufactured by the company?s transgenic goats, which contain a human gene that directs production of the anti-clotting protein in their milk.

It?s a cool approach. The only antithrombin III approved in the United States today is purified from donated human plasma, an unpredictable source that periodically dries up, leaving American patients scrambling. And compared to conventional means of producing biological drugs, such as gene-altered bacteria grown in vats, goats are stalwart and generous, churning out massive quantities in every glass of the white stuff. ?Got Antithrombin III? You betcha!?

GTC?s application is the first of its kind, but others are on deck. The company, along with more than 20 other research teams around the country, anticipates a not-too-distant future in which transgenic farm animals will make many human medicines. Endowed with the right genes, a small herd of lactating goats could squirt out enough malaria medicine for all of Africa faster than you could sing a few verses of ?Old MerckDonald had a Pharm.?

Problem is, federal regulators were not fully prepared when the folks at GTC anted up for a fast-track review. As I?ve written, it was not until September that the FDA released a draft version of its Guidance for Industry #187, which would codify how the agency will review applications to approve food or drugs from gene-altered farm animals. The agency accepted public comments through December and has yet to release any final guidance.

That made for an awkward situation on Friday, when an FDA advisory committee was asked to rule on whether the medicine made by GTC?s goats was safe and effective and therefore suitable for sale?without the agency?s veterinary center having even finished writing the rules on what constitutes an acceptable production process in animals.

Also embarrassing, if not plainly disingenuous: Agency officials had promised that its reviews of the first foods and drugs made in gene-altered animals would include public meetings at which they would discuss animal welfare, environmental, and public health issues openly. Yet Friday?s meeting had jurisdiction only over the safety and efficacy of the drug itself. After some hemming and hawing, FDA veterinary officials conceded that no public meeting dedicated to those other important issues was likely to happen for this first approval, in part because of statutory requirements that demand the agency move quickly on applications, such as this one, that have won fast-track designation. (The company?s hurry was not explained. In similar cases the problem has often been a shortage of funds and the need to achieve a key regulatory success in order to attract fresh venture capital.)

Friday?s presenters did divulge a few details about ATryn pharming. Company officials and FDA scientists (who have repeatedly inspected GTC?s operations), described all seven generations of the clot-busting goats as hale and healthy (indeed, the founder goat?the grand patriarch of this valuable line?was repeatedly described using the scientific term ?handsome fella?). To prevent escape and ensure that their meat and medicinal milk never find their way onto grocery shelves, the goats are double-fenced and under constant video surveillance. They even have electronic transponders implanted under their skin so scientists can track them, if necessary, through the Massachusetts woods. A shockingly thin (read: single sheet of paper) agency-led ?Environmental Assessment? concludes that the herd ?is unlikely to result in significant effects on the environment.?

Several observers, including Greg Jaffe, director of biotechnology at the Center for Science in the Public Interest, were rightly unimpressed.

?More information about the risk analysis surrounding the genetically engineered goats needs to be made public and scrutinized by independent experts before any product approvals,? Jaffe told me, calling the FDA?s work to date ?a good first step.?

Nina Mak, a research analyst with the American Anti-Vivisection Society, raised animal welfare issues. Typically, she said, hundreds to thousands of animals are engineered before an acceptable founder is created. ?Unintended and unexpected problems are frequent, greatly increasing animal suffering.?

Mak said it was ?astounding? that the FDA would consider approving a drug from a genetically engineered animal when it has not even decided what the rules for such approvals should be. She is right. The only tempering factor is that a number of FDA officials all but conceded that they, too, were chagrined. ?Ordinarily,? said the FDA?s Eric Flamm, ?we may want to coordinate the two reviews? of the drug itself and of the engineered animals and their various impacts.

After the advisory committee was told, to some members? open dismay, that it could consider only whether goat-derived ATryn is safe and effective in patients, it voted yes. A final FDA decision is expected by next month. By then the FDA will presumably have released a more finished document describing the rules for approving drugs from gene-altered animals (I predict a release on Jan. 16, the last government workday of the Bush administration), and agency officials will have declared that GTC?s goats passed muster, though it will be too late for the public to weigh in.

A lot of eyes ought to be watching to see if the agency keeps its promise to do better next time.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Tags: FDA, genetics, pharma, regulation

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One Response to ?Speedy FDA Process Gets Observers? Goats?

1. Jaydee Hanson says:

Rick Weiss? comments are a good review of the meeting. Here are the comments I made to the FDA at the meeting. Jaydee Hanson, Policy Analyst, Center for Food Safety

Jaydee Hanson comments to FDA Blood Products Advisory Committee, Jan. 9, 2009

As you consider possible approval of the first drug derived from a genetically engineered mammal, I would urge the committee to only approve the drug AFTER the approval of a regulatory framework for bio-pharmaceutical animals in general followed by a specific approval of the GTC Biotechnologies goats.

The materials shared with the public about Atryn moreover, raise concerns about the product itself. There are significant differences between the genetically engineered form of the drug and the human form it is designed to replace. These include: glycosylation differences, increased heparin binding, and a shorter half life in the body of the patient. Significant associated problems have been reported in the small number of patients treated thus far (fewer than 40 patients). Scientific literature suggests that there are perhaps 130 variants of the gene believed to be associated with this condition.

If the committee does approve the drug, strict post market surveillance should be required, including surveillance of the infants of women treated with the drug during pregnancy. Biological drugs have shown a high incidence of problems post market, we should not assume that this drug will be any different.

Drug approval should be limited to products derived from this goat herd raised with the safe guards described here today.

Animal approval should be given only for animals raised at this location and only as long as it is subject to continued review by FDA and USDA. No sale of animals to other facilities, or leasing of production techniques to other facilities should be given by the approval of these animals.

Given that there have been cases of GE animals being consumed by workers or sold to others, studies on food safety on the meat, milk, and cheese products from these goats should be required prior to approval. Studies on the safety of these goats, if used as animal feed should also be required.

Inadequate steps have been taken to address the infection of the animals by birds, rats, mosquitoes, and other vectors. Assessment of these issues should be part of an expanded environmental risk assessment on the goats that looks at all aspects of the goat lifecycle from creation of the animal to disposal of the animal after death. The full environmental risk assessment should be posted as part of any FDA approval of the animals. Data on the destruction of each animal created by GTC should be posted. This should include ?no-takes? and all animals not kept in the herd.

Finally, no drug approval should be given before FDA approves the animal. No animal approval should come prior to the FDA completion of regulations (not simply guidances) for Bio-Pharm animals wherein all data used for the approval of animals is made available to the public. The FDA has tried to fit the approval of animals themselves into the New Animal Drug approval process. If this process cannot be adapted to provide for complete transparency of data, then the FDA needs to delay approvals until it has this authority from Congress.

Approving ATryn before the FDA has developed a framework for the approval of Bio-Pharm animals would make drug approval a back door approval of transgenic animals. This would be a case of FDA getting the cart before the horse, or in this case, the goat! The public deserves better. The patients deserve better.