WASHINGTON - Companies and farmers honoring the FDA's voluntary moratorium on selling food and dairy products originating from cloned animals are one step closer to seeing their goods in the marketplace in the next year or so.
In advance of an FDA Veterinary Medicine Advisory Committee meeting Tuesday, the agency released a draft executive summary on animal cloning safety, stating: "The current weight of evidence suggests that there are no biological reasons, either based on underlying scientific assumptions or empirical studies, to indicate that consumption of edible products from clones of cattle, pigs, sheep or goats pose a greater risk than consumption of those products from their non-clone counterparts."
The safety assessment builds upon findings of the National Academy of Sciences (NAS), which the agency commissioned two years ago to consider scientific information on animal biotechnology. A prepared statement released by the FDA said while the NAS believes food from animal clones poses only a low level of safety concern, it would be prudent to have more data to minimize further concerns. (The voluntary moratorium went into effect two years ago when the FDA determined it needed additional safety information on the practice.)
Indeed, Tuesday, eight of 10 members of the Veterinary Medicine Advisory Committee agreed that food from cloned animals or their offspring would be safe to eat, The Washington Post reported Wednesday. The FDA is not bound by recommendations of its panels.
Lisa Dry, communications director at the Washington-based Biotechnology Industry Organization, told BioWorld Today that BIO is supportive of the FDA's draft assessment.
"Our big concern right now is for the FDA to give a green light to letting the companies and the livestock producers involved with these animals market their products," she said. "Many of these are small companies with high burn rates, so they don't have a lot of revenue coming in - they are in a very difficult situation."
However, she cautioned that the solution is not necessarily just around the corner.
First of all, regarding the draft safety assessment, the FDA merely released 12 pages of a 300-page document without specifying when the rest of the report would be available. Dry believes it will be in the next two to six months.
And once the report is out, the agency is compelled to take public comment on it. Dry said the agency is probably about a year away from giving the go-ahead for marketing the products.
In its summary, the FDA describes cloning as a process that allows livestock breeders and others to replicate their best animals that are then used for breeding stock. The Center for Veterinary Medicine is focusing on the cloning technique known as somatic-cell nuclear transfer, the technique that produced Dolly the sheep July 6, 1996.
FDA Issues Guidance On Pharmacogenomics Data
The FDA issued a draft guidance document that encourages drug and biologics developers to conduct pharmacogenomic tests during drug development and describes how the FDA will evaluate the resulting data.
Pharmacogenomics deals with the small genetic differences that help explain why some people respond positively to a drug while others either don't respond or experience side effects.
Releasing the guidance is the agency's first step toward integrating pharmacogenomics into the drug review and approval process, the agency said. The guidance is intended to ensure that evolving regulatory policies and study designs are based on the best science, provide public confidence in the scientifically appropriate field, facilitate the use of such tests during drug development, and clarify for industry what types of pharmacogenomic data to submit, a prepared statement from the FDA said.
Gillian Woollett, BIO's vice president for science and regulatory affairs, released a statement saying the draft guidance proposes a mechanism for comfortably sharing exploratory pharmacogenomic information with the FDA without studying ongoing drug development.
"Although we have not yet had an opportunity to review the details, the biotechnology [sector] supports the concept of such voluntary genomic data." Woollett said. "This is an example of the FDA working with the industry to anticipate regulations and understand what the appropriate regulations should be."
Scientific understanding of pharmacogenomics is most advanced in the drug metabolism area, but the FDA expects rapid evolution of additional uses, it said.
The draft guidance can be viewed on the FDA's web site at www.fda.gov.
BIO, the Pharmaceutical Research and Manufacturers of America and the Pharmacogenetics Working Group in conjunction with the FDA are sponsoring a workshop in Washington Nov. 13-14 to discuss the role of pharmacogenomics drug development and regulatory decision making.
Government: Biotech Is Strong Engine Of Innovation
Results from a Department of Commerce survey of U.S. companies' biotechnology-related business activities show higher rates of growth, capital and research and development intensity, compared to the respondents' overall businesses.
For example, according to the DOC, in 2001 and 2002 growth for biotechnology net sales averaged just more than 10 percent, while net sales for the responding 3,200 firms rose an average annual rate of about 6 percent.
In August 2002, the DOC mailed out the 25-page survey to determine the use of biotechnology in U.S. industry. (See BioWorld Today, Aug. 28, 2003.)
The DOC will release detailed results of the survey in a press conference Nov. 13 in Washington. The purpose of the survey is to assist U.S. policymakers in assessing the health of the biotech industry and identifying the most significant barriers to industry competitiveness, such as research costs and access to start-up capital.
Among its findings, the DOC said that in 2001, reported biotechnology-related R&D expenditures amounted to $16.4 billion, or about 10 percent of all R&D conducted by U.S. industry that year.
Biotechnology companies providing data for 2000-2002 averaged 12.3 percent annual work-force growth, with the largest increases in small firms (those with 50-499 employees). During the same period, growth in non-farm payroll employment in the U.S. was essentially flat, said the DOC.