WASHINGTON - A government research council believes the United States Department of Agriculture should consider requiring developers of genetically engineered organisms to practice "bioconfinement" methods such as induced sterility to prevent transgenic animals and plants from entering the environment and adversely affecting their counterparts or others.
The recommendation is part of the National Acad-emies of Science's (NAS) report, "Biological Confinement of Genetically Engineered Organisms," which was commissioned by the USDA.
At issue here is the regulation of a number of genetically engineered organisms that weren't in existence when the federal government's original 1986 "Coordinated Framework" for regulation of biotechnology was enacted, the NAS said.
Ecological studies have shown that some genetically engineered organisms are viable in natural ecosystems and can breed with wild relatives. The most publicized environmental danger is that powerful weeds could be created if transgenic crops, engineered to tolerate herbicides or to resist diseases and pests, end up passing those traits to weed-like flora. Plants also can be engineered with traits that allow them to grow faster, reproduce more and live in new types of habitats.
An additional risk, the NAS said, is that transgenic fish or shellfish could escape and mate with their wild counterparts or out-compete them for food. And still another concern is that plants and animals engineered to produce pharmaceuticals could, if accidentally consumed, harm humans or other species.
The NAS suggested that confinement for certain new organisms might become one of the requirements for approval.
The Biotechnology Industry Organization (BIO) said the "forward-looking" report acknowledges the need for flexibility in the regulatory framework.
BIO believes all regulations should be science based, should be focused on only the properties of the transferred gene and not where it is derived, and that the level of regulation should be comparable to the level of risk.
Copies of the report will be available later this year from the National Academies of Science's press office. Additional information can be obtained on the website at www.nationalacademies.org.
The USDA is accepting comments on its proposal to update and strengthen its biotechnology regulation for the importation, interstate movement and environmental release of certain genetically engineered organisms.
Comments should be sent to Docket No. 03-031-2, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road, Unit 118, Riverdale, Md., 20737-1238.
Legislative Issues: Human Organisms, Orphan Drugs
Lawmakers reconvened Tuesday for the second session of the 108th Congress with a pile of work on their desks.
Among the first bills to come up for vote in the Senate was the $328 billion spending bill, which passed in a 68-28 vote Thursday. The legislation has already passed in the House, so now it's on its way to President Bush's desk.
It includes a provision that prevents the U.S. Patent and Trademark office from issuing patents on "human organisms." (See BioWorld Today, Dec. 22, 2003.)
While a few concerns have been raised about the interpretation or definition of human organisms, Michael Werner, BIO's chief of policy, told BioWorld Today he believes the provision is meant to reaffirm current USPTO policy, which prohibits the patenting of a human. Because the provision is part of the spending bill, it will have to be voted on annually.
Meanwhile, BIO forwarded President Bush a package of legislative priorities that addresses topics such as Medicare, the reimportation of prescription drugs from foreign countries and genetic discrimination.
But another, less publicized issue in the package takes up the orphan drug tax credit, which was enacted in 1983 to encourage companies to develop therapies for rare diseases or conditions that affect 200,000 people or less. The credit applies to 50 percent of qualified clinical trial expenses incurred with respect to designated orphan drugs, BIO said.
Unfortunately, BIO said, the tax only applies to expenses incurred after the FDA designates a product as an orphan. Because of this, BIO believes many companies wait until they receive orphan status before initiating certain trials, which ultimately delays a drug's entry to market. Legislation introduced in the House last year called "The Tax Relief, Simplification, and Equity Act of 2003" would correct that problem.
FDA Warns Companies To Stop Illegal Imports
The FDA issued a warning letter to three Temple, Texas-based companies notifying them that it considers their drug import programs illegal.
Companies receiving a letter were Expedite-Rx, SPC Global Technologies Ltd. and Employer Health Options Inc.
A prepared statement from the FDA said the letters accuse the companies of "facilitating illegal imports of prescription drugs from Canada and misleading the public about the safety of the products."
The companies help clients buy prescription drugs. FDA policy permits individuals to import nonapproved drugs that are unavailable in the U.S., if those drugs are not commercialized to Americans.
Furthermore, Medicare reform contains a provision allowing reimportation of FDA-approved drugs from Canada if Tommy Thompson, secretary of Health and Human Services, certifies that it is safe, which he has not done.
The FDA believes foreign versions of FDA-approved drugs generally are not up to U.S. standards.
Expedite-Rx, SPC Global Technologies and Employer Health Options have 15 days to inform the FDA about specific steps they will take to bring their operations in compliance U.S. law, the agency said.