NIH MAP REVIEW INDUSTRY DNA PROPOSALS
NIH MAP REVIEW INDUSTRY DNA PROPOSALS, but is not required to do so, according to a June 25 D.C. Federal Court ruling in Foundation on Economic Trends v. Margaret Heckler. The decision denies a foundation request filed last fall for a preliminary injunction against NIH approval of deliberate release experiments by private firms. Authored by the court's chief Judge, Aubrey Robinson, Jr., the decision cites a Feb. 27 appellate court ruling which "clearly held that there is presently no legal basis to enjoin the NIH review and approval process, even though particular experiments can be enjoined if approved without the required environmental analysis." The appellate court decision overturned an injunction against NIH approval of deliberate release experiments, but prohibited a particular experiment -- - a University of California (Berkeley) test to prevent ice nucleation -- - from proceeding until an environmental assessment is completed. If the plaintiffs intended this motion to bar NIH approval of private pro posals, then they were seeking to enlarge the very part of the preliminary injunction which was vacated on appeal," Robinson wrote. The Foundation on Economic Trends had asserted in its motion that NIH has an "enforceable" policy of regulating private firms, according to the decision. While the court acknowledges that NIH has "considered a number of policy alternatives" for regulating industry DNA research, it says the agency currently requires private firms to agree only to "voluntary compliance" with NIH DNA guidelines. "Accordingly, the court finds no legal grounds to compel NIH to regulate private firms."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth