By Lisa Seachrist
WASHINGTON ¿ Many FDA-regulated industries have banded together to offer their enthusiastic support to increase funding for the chronically underfunded agency.
Eleven organizations representing regulated industries ranging from the Biotechnology Industry Organization (BIO) to the Grocery Manufacturers Association to the American Veterinary Medical Association have signed a letter penned to Rep. Joe Skeen (R-N.M.), chair of the Subcommittee on Agriculture, Rural Development, and Related Agencies of the House Appropriations Committee, endorsing President Clinton¿s plan to increase the funding for FDA by 13 percent.
¿Seeing an increase in FDA appropriations is one of our legislative priorities this year,¿ said Michael Werner, director of federal government relations/bioethics counsel for BIO. ¿We organized a coalition of different industries all regulated by FDA. All of us have different views on how FDA should allocate its resources, but we all agree it needs more funding.¿
Werner said the coalition, in general, would like to see substantial increases in the funding for FDA and chose the Clinton administration¿s proposal because it represented a ¿real number.¿
¿From our perspective, if Congress wants to appropriate more funds to FDA, all the better,¿ Werner said. ¿What we want to do is have Congress start to move in the right direction. Getting Congress to recognize [FDA has] been underfunded is the first step in that direction.¿
Jeff Trewhitt, media spokesman for another letter signatory, the Pharmaceutical Research and Manufacturers of America (PhRMA), pointed out the agency needs to have full funding in order for the agency to collect the user fees associated with Prescription Drug User Fee Act (PDUFA).
¿We¿re happy with the 13 percent increase,¿ Trewhitt said. ¿It will bring the agency up to full federal funding. Sure, we¿d like to see more but we¿re pragmatic as well.¿
Werner said a similar letter would be sent to the Senate Appropriations Committee later in the year.
Gene Therapy Moratorium To Be Topic At RAC
When the Recombinant DNA Advisory Committee (RAC) meets March 8-10, its members will consider whether to recommend a moratorium on all gene therapy protocols using viral vectors.
The RAC decided to take up the new agenda item at the behest of Jeremy Rifkin, president of the Foundation on Economic Trends. In a letter dated Nov. 22, 1999, Rifkin requested RAC impose an immediate moratorium on the ¿consideration of any future human somatic gene therapy protocol that employs retro-, adeno- or other viral vectors, except where the protocol can legitimately be considered a treatment of last resort for a life-threatening illness.¿
Rifkin made his request in the wake of news of the death of University of Pennsylvania gene therapy patient Jesse Gelsinger. The RAC announced its intention to consider the moratorium in a Feb. 18, 2000, Federal Register notice.
Since the suspension of gene therapy clinical trials by FDA at the University of Pennsylvania, the Cystic Fibrosis Foundation and the Muscular Dystrophy Association voluntarily stopped gene therapy trials. Beth Israel Deaconess Medical Center in Boston has also placed its gene therapy programs on a voluntary hold until the FDA and NIH work out whether gene therapy is considered safe.
Boxer Aims At Genetically Modified Food
Maintaining consumers have a ¿right-to-know,¿ Sen. Barbara Boxer (D-Calif.) introduced legislation last week to require labels to warn consumers when a product contains genetically engineered foods.
The bill, S. 2080, titled the Genetically Engineered Food Right-to-Know Act, would require the labeling of food that contains a genetically engineered material or is produced with a genetically engineered material. The bill would also provide funds to study the effects of genetically modified foods.
¿Despite the prevalence of genetically engineered food, the effects of its use remain largely unknown because of a lack of studies,¿ Boxer said in a statement. ¿So there are two problems: Consumers don¿t know what they are eating, and there are no studies on the subject.¿
BIO vigorously opposes such legislation, claiming the Boxer bill attempts to fix a problem that doesn¿t exist. Currently, manufacturers are permitted to provide choice to consumers via voluntary labels allowing consumers who wish to avoid biotech foods the opportunity to do so.
Boxer¿s bill has no co-sponsors yet; however, it is similar to a House measure offered up by Rep. Dennis Kucinich (D-Ohio).