ANIMAL WELFARE ACT REVISIONS WOULD COST PMA MEMBERS ALONE $345 MIL.

ANIMAL WELFARE ACT REVISIONS WOULD COST PMA MEMBERS ALONE $345 MIL., or more than half the national total estimated by the Department of Agriculture's Animal and Plant Health Inspection Service (APHIS), the Pharmaceutical Manufacturers Association (PMA) maintained in May 15 comments. "Our member firms, representing [only] 5% of the facilities, will incur costs of $345 mil. or 62% of that [$557 mil.] estimated by APHIS for all 1,293 research facilities" under the revisions, PMA asserted.

PMA projects that capital costs for U.S. pharmaceutical companies to meet compliance "are $263 mil. and annual operating costs are $82 mil." At the end of the three years that APHIS has allowed for compliance, PMA companies' capital and operating costs "will be $595 mil," the association maintained. Of this, "$90 mil. has already been spent in anticipation of the regulations." The APHIS estimate of costs to research facilities PMA argued, "is at least several times too low."

PMA submitted comments to APHIS in response to the revised rules, published March 15 in the Federal Register, implementing the amended Animal Welfare Act of 1985. The APHIS proposal is a new version of a March 31, 1987 proposal to revise the animal welfare regulations.

Under the most recent proposal, "each research facility must require that the animal care and use procedure (ACUP) for any procedures and practices involving live, warm blooded animals be approved by the [Institutional Animal Care and Use] Committee, prior to the start of research, testing, or teaching involving an animal." The committee "will be involved with reviewing how the research will treat or affect an animal," the revised rule states, but "will not be involved in evaluating the design, outlines, guidelines, and scientific merit of proposed research."

In addition to its concerns regarding costs, PMA contends that the proposal exceeds the statutory limitations of the original legislation, giving "extensive regulatory responsibilities" to the Institutional Animal Care and Use Committees, particularly in its authority to review and pre-approve research procedures as well as halt research proceedings. Initially, the association maintains, the act limited committee authority to inspection and reporting functions only.

Furthermore, the association asserted, the proposal would cause delays in research programs and drug development as well as interfere with the independence of the research process. PMA predicts that indirect costs incurred because of delays would exceed $100 mil. The association also objects to the provision requiring a research facility to provide "any information concerning the business of the . . . research facility . . . which the APHIS official may request in connection with the enforcement of the Act." One possible consequence of such a rule, the association says, is that the information "may be subject to public disclosure pursuant to Freedom of Information Act proceedings."

Other PMA concerns are: "the requirement that the committee inspect each and every procedure involving pain"; "the requirement that the committee complete its inspection of all facilities within (30) days"; "the per se violation that would occur even though a person unintentionally and unknowingly purchases, uses, or transports a stolen animal"; and "the taking of photographs during an APHIS inspection."