The Industrial Biotechnology Association is so anxious for theFDA to step up the pace of new drug reviews that on Monday itthrew its support behind a congressional plan that wouldimpose new fees on its member companies.

It was a reversal of a prior position at the IBA, which had longmaintained that "(new drug) application fees are a tax oninnovation."

The IBA, which represents most of the large biotechnologycompanies, was not alone. The Pharmaceutical ManufacturersAssociation (PMA), whose members include most of the bigdrug companies, also supported the idea of fees before aninitial hearing on Monday of the health and environmentsubcommittee of the House Energy and EnvironmentCommittee. The Association of Biotechnology Companies (ABC)wrote a letter to the committee reportedly endorsing the feeconcept.

What apparently brought the IBA around was a growingbacklog of drug reviews before the FDA and a growinglikelihood that both Congress and the Bush administrationwould yet agree on some version of FDA fees.

If such a bill is signed into law before Congress adjourns for thefall election campaigns, drug developers could start seeing thefees sometime after the start of the federal government's fiscalyear on Oct. 1, Richard Godown, the IBA's executive director,said Monday.

"There seems, for the first time on the user fee question, acoalition of opinion" uniting industry and lawmakers, Godownsaid.

The IBA and ABC aren't giving carte blanche support to thefees, which are being proposed in three forms: new drugapplications (NDAs), an annual maintenance fee for approveddrugs and an establishment licensing fees for reviews of drugmanufacturing facilities.

The IBA's position sets several conditions for its support. Itwants assurances that the fees be:

-- Reasonable. Although not clearly defined by the IBA,reasonable generally means that the new drug applicationsshould generate the smallest amount of revenue of the threefees, Godown said.

-- Used exclusively for improving the FDA's capabilities, not todisplace existing FDA funds for other purposes, such asindustry enforcement.

-- Budgeted so that the FDA's Center for Biologics, whichreviews many applications for biotechnology products, receivesa fair share of the new funds.

"This bill is not perfect," Godown said. "We'd prefer that it'd bedone without application fees, just with product maintenanceand establishment fees."

Draft legislation drawn up by subcommittee Chairmen HenryWaxman, D-Calif., calls for a $150,000 fee for a drug applicationand lesser fees for an annual product maintenance fee andfacility review.

Godown said the IBA has not established an opinion on the$150,000 fee proposed by Waxman. However, he predicts thatsome version of the bill will sail through the congressionalcommittees and stands a good chance of being signed byPresident Bush.

FDA Commissioner David Kessler, a Bush appointee, testified insupport of new fees. "To get more drugs on the market, theonly answer is to provide more reviewers," he said.

Kessler outlined a fee system that would generate $35 millionin its first year, $50 million in its second year and $75 millionannually thereafter, with all the new funds going to expandedFDA review efforts. One possible use of the additional revenueswas a proposed $18 million, three-year overhaul of thecomputer systems used to track drug test data and FDAreviews, he said.

-- Ray Potter Senior Editor

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