Biotech lawsuits filed, regs amended.

Biotech lawsuits filed, regs amended

It has been a busy season for the proponents, opponents and components of biotechnology regulations. The latest events are this week's filing of a summary judgment motion in U.S. District Court asking that the federal government recall a genetically engineered vaccine, and the amending of recombinant DNA guidelines by a federal advisory board.

The vaccine, designed to protect swine against pseudorabies, a viral disease that can kill pigs, has been the subject of controversy for nearly a year. Derived from a live virus with part of its genetic material deleted, the vaccine had been field-tested and was in commercial use when the U.S. Department of Agriculture (USDA) stopped its sale last April (SN: 4/12/86, p.228), but allowed sales to resume a month later (SN: 5/10/86, p.295). The motion filed this week by the Washington, D.C.-based Foundation on Economic Trends is related to a suit it filed last spring charging that USDA did not follow correct procedure in approving the vaccine for sale.

A suit filed in November against Novagene, Inc., Houston-based developer of the vaccine, resulted in this week's summary judgment request by the foundation, which is headed by activist Jeremy Rifkin. The November suit was filed by TechAmerica Group, Inc., of Omaha, Neb., which produces the vaccine. According to papers filed in a Houston federal court, TechAmerica accuses Novagene of "knowingly misrepresenting certain key characteristics" of the vaccine, including information regarding its safety.

Rifkin said in an interview that the TechAmerica suit, which he feels questions Novagene's scientific results, strengthens his foundation's criticisms of the regulatory process. However, a TechAmerica spokesman says the issue was not a problem with Novagene's research results. And David Banker, Novagene's chief operating officer, told SCIENCE NEWS that "the product is totally safe as determined by the USDA, and we stand behind it." Neither Novagene nor TechAmerica will discuss the scientific or legal details -- leaving questions unanswered regarding the suit's possible effect on the vaccine's availability.

David Espeseth of the Animal and Plant Health Inspection Service, the Hyattsville, Md.-based USDA branch that that approved the vaccine, says the TechAmerica suit most likely will not affect the vaccine's federal approval. "We certainly haven't seen anything that would suggest need for a change in the current status [of the vaccine]," he says.

A special National Institutes of Health (NIH) committee was appointed last year to investigate the field-testing of the vaccine, which was directed by Saul Kit of Baylor College of Medicine in Houston, developer of the vaccine for Novagene (SN: 5/10/86, p.295). Recently, that committee midly reprimanded Kit for not consulting biotechnology advisory committees before conducting those tests.

The NIH action illustrates the confusion surrounding biotech regulations. It has been unclear what actually constitutes a "deliberate release" of organisms into the environment, and whether, for purposes of NIH review, gene deletion procedures should not be considered part of genetic engineering, since no foreign genetic material is introduced. The question of which federal agency has jurisdiction over an individual genetically engineered product or process is yet another gray area. In a continuing effort to address these questions, NIH's Recombinant DNa Advisory Committee met this week to refine some of its guidelines.

In amending previously accepted guidelines, committee members agreed that additional approval for recombinant DNA experimentation from NIH was not necessary if already obtained from another federal agency -- with the notable exception of human gene therapy. Rather than accept a proposed redefinition of "recombinant DNA, the committee voted to exempt certain types of organisms from normal review. It also voted to loosen regulation of large-scale fermentation processes using genetically engineered strains of certain organisms.