WASHINGTON _ How do you spell relief? R-E-G-U-L-A-T-O-R-Y R-E-F-O-R-M, if you're among the swelling ranks of groups herethat want federal regulators to back off.

Since the Republican sweep of the House and Senate races on Nov.8, anti-government regulation organizations have been streaming outof the woodwork.

A new, non-profit coalition of businesses, think tanks and tradeassociations calling itself "Project Relief" recently added its voice tothe chorus. Rep. Tom DeLay (R-Texas) launched Project Relief'scampaign to "break the chokehold of regulation in America" at apress conference here on Wednesday.

Although the group has yet to directly address reform of the FDA,the regulatory agency at the heart of most biotechnology companies'dealings with government, the impact on that agency of one ofProject Relief's near-term legislative goals could be profound, if it isachieved.

"Project Relief represents what I hope will be the biggest effort everto seek regulatory relief for small businesses, industry and indeed,average Americans," said DeLay, who will be the new HouseMajority Whip and the pointman on regulatory reform issues.

First up on the project's agenda is passage of the Job Creation andWage Enhancement Act (JCWE Act), one of the 10 bills included inthe Republican "Contract with America."

The JCWE Act seeks to impose some red tape on the regulatorsthemselves, according to DeLay. Any new regulation proposed by afederal agency would undergo detailed risk assessment andcost/benefit analyses under the proposed new legislation. Currently,there are mechanisms to assess the economic impact of new laws andregulations: legislation must be "scored" for its budgetary impact bythe Congressional Budget Office before it can proceed to the Houseor Senate floor for debate; and regulations proposed by theExecutive branch (including agencies such as the FDA,Environmental Protection Agency and U.S. Department ofAgriculture) must be reviewed by the Office of Management andBudget for economic impact.

But, if passed, the Republican-sponsored JCWE Act would up theante considerably. According to the language of the proposed bill,risk assessments would be based on a "scientific evaluation of therisk addressed" and "supported by the best available scientific data."The analyses would have to "explicitly distinguish scientific findingsin risk assessments from other considerations affecting the designand choice of regulatory strategies." Any "policy or valuejudgments" used in the analyses that were "non-scientific in origin" would have to be explained and justified.

Risk assessments and cost/benefit analyses prepared by would-beregulators would then undergo peer-review by independent panels toensure that they were based on "sound science." The panels wouldbe staffed by "scientific experts in the appropriate disciplines withrecent professional experience." (Panel members would have to fillout financial disclosure forms.)

Under the proposed JCWE Act, preference would be given to "theleast costly regulatory alternative that accomplishes programobjectives." Another provision would give consumers and smallbusinesses the right to ensure that federal regulators adhere to theAct by making it "enforceable by citizen suits, so that agencies canbe sued for not implementing cost/benefit analysis, risk assessmentor sound science."

The scope and extent of the new analyses and justifications requiredin the JCWE Act would appear to create even more government-generated committees and analyses than those that currently bogdown federal lawmaking, but Rep. DeLay said that was a clear aimof the act. "We are imposing red tape on the bureaucrats and I can'tthink of anyone better to impose it on," he said. "They should haveto justify why they are creating new regulations."

FDA reform will be a top priority once Project Relief's near-termgoals are achieved, according to steering committee memberEdwards Hudgins, who is also director of regulatory studies at thelibertarian Cato Institute think tank.

"We are developing a `dirty dozen' list of agencies and laws thatneed to be rolled back once the Contract with America has beenenacted," Hudgins told BioWorld. "The FDA is definitely on thepost-contract hit list." n

-- Lisa Piercey Washington Editor

(c) 1997 American Health Consultants. All rights reserved.