PRESIDENTIAL COUNSEL TO ADVISE ON BIOTECHNOLOGY POLICY ISSUES
PRESIDENTIAL COUNSEL TO ADVISE ON BIOTECHNOLOGY POLICY ISSUES should be established, DuPont chairman Edward Jefferson stated at a Sept. 12 dinner commemorating the firm's new research facility. Calling for the appointment of a special counselor to the president, Jefferson asserted that such a person "could provide the govt. with an independent spokesperson who could make policy recommendations and comment on regulatory developments with the assurance that his or her comments would also be heard at the highest levels of govt." Speaking before a group of DuPont execs, scientists and guests, the DuPont chairman suggested that a special counselor to the president "would aso be in a position to promote the expansion and funding of biotechnology research." Jefferson also called for the establishment of an interagency cmte. to "serve as a sounding board for those subject to regulation, as well as environmental and other citizen groups." In addition, Jefferson cited the need for a clear definition of jurisdiction among federal agencies. Stating that the "creation of a jurisdictional matrix" to establish what biotechnology products should fall under which agency's jurisdiction, Jefferson said such a determination is necessary in order to "anticipate and clear up jurisdictional disputes before products are proposed for approval." Jefferson stressed that federal regulation is necessary to avoid regulatory and legal uncertainties and to end what he called a "regulatory limbo" for industrial biotechnology. Although Jefferson commenced the Natl. Institutes of Health Recombinant DNA Cmte. (RAC) as a concept that "has worked well in practice," he said the cmte. has "no authority over independent, privately financed research." Noting that "several govt. agencies also have a claim to jurisdiction over biotechnology and their legally mandated areas of administration," Jefferson suggested that each agency dealing with biotechnological products regulation establish guidelines to provide "a consistent basis for the oversight to be exercised by each agency." Although Jefferson called for executive branch coordination of biotechnology regulations, he stated that RAC should be maintained "until the regulatory process is functioning smoothly." Jefferson's comments preceded three days of activities surrounding the Sept. 14 dedication of DuPont's 152 acre Life Sciences Research complex located outside Wilmington. Named in honor of former DuPont chairman and CEO Crawford Greenewalt, the building houses research and development facilities for pharmaceuticals, medical diagnostics and agriculture chemicals.
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