ANIMAL WELFARE REGULATORY REVISIONS COULD COST $ 1 BIL. ANNUALLY
Executive Summary
ANIMAL WELFARE REGULATORY REVISIONS COULD COST $ 1 BIL. ANNUALLY, Health and Human Services Undersecretary Constance Horner believes. She stated her concern about the effect of additional regulatory controls on animal research during a June 14 meeting of alumni of her graduate school (University of Chicago). The new regulation, which Horner said is sometimes referred to "crudely and unkindly" as the 'Happy Animal Regulation," is likely to "cost American research $ 1 bil. a year." Horner commented on the impact of the new regs by saying they will "guarantee certain levels of fluorescent lighting, indicate certain sizes of cages that are nationally uniform, and all kinds of rules like this." Horner is concerned that the animal rights movement has developed into an "attack on science." Noting that $ 7 bil. is spent annually by the National Institutes of Health on public research and another $ 7 bil. is financed from private sources for a total of $ 14 bil., Horner maintained that "if you subtract $ 1 bil. from that just for the cost of a new regulation, you have an attack on science." Horner predicted that HHS Secretary Sullivan, "a research physician," will address the subject of animal rights shortly. PMA has estimated that the new regulations will cost PMA companies $ 345 mil. -- $ 263 mil. for compliance and $ 82 mil. for operating costs ("The Pink Sheet" May 29, T&G-8). The Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) has estimated a cost of $ 557 mil. for 1,293 research facilities nationwide. Under newly revised regulations published in the May 15 Federal Register, an animal care and use procedure for warm blooded animals must be approved by Institutional Animal Care and Use Committees prior to the start of research. Horner contended that new controls are not necessary. "Animal research," she said, is already "extensively regulated in this country." Horner observed that the regulation is a "political response to the animal rights movement." "The animal rights movement has had an impact on the scientific enterprise," Horner said, warning that the movement is "in its infancy." Acknowledging that "early on the movement did increase sensitivity among scientists to the care of their animals," Horner said the movement is now creating a "bunker mentality." She maintained that drug firms are "closing down research into new drugs" because of personal threats by the animal rights activists. The HHS undersecretary said that their effect on research is largely unnoticed because the drug companies are not publicizing their reactions. Responding to criticisms made by animal rights activists that animal research is wasteful and duplicative, Horner pointed out that "federal grants which involve animal research are highly competitive [and that] science requires overlapping studies." Furthermore, "research grant applications are reviewed for both scientific merit and the appropriateness of animal use [and] have to be in compliance with all HHS animal welfare policies," Horner stressed. The HHS undersecretary said that she does not approve of animal testings for cosmetics. She strongly stated her objections to that testing as an "unconscionable use of money." * Horner also characterized the recent congressional investigations into scientific fraud as another type of political attack on science. Referring to a hearing by Congressman Dingell (D-Mich.) into allegations of scientific fraud by Nobel Laureate David Baltimore, Horner said: "I am profoundly uncomfortable at the notion that a congressional committee sends out hired investigators to subpoena and seize scientific notes. No congressman should be delving into the degree of replication of an experiment." She added that "it should be the peers that are doing this, not elected officials who have political goals in mind.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
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 Skin Infections Guidance Spurs Debate On Endpoint Relevance
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
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