WASHINGTON _ A bill to ease restrictions on the export of non-FDA-approved drugs and devices and to expand the number ofcountries eligible for export was introduced in both the House andSenate on Wednesday. The proposed legislation redresses a majorgrievance of industry and, to a degree, upstages President Clinton'sdetailed reform plan for the agency _ expected in a matter of weeks_ that may contain similar provisions.
The FDA Export Reform and Enhancement Act of 1995 would allowexport of drugs, biologics and other health care products from theU.S. to other countries without regard to U.S. approval status if theproducts meet four requirements. Those requirements are that theproduct must be approved in the foreign receiving country, mustcomply with national laws, must be labeled clearly for export andmust not be sold or offered for sale in the U.S.
Current law permits the export of such products, but only to 21designated countries, the majority of which are industrializedEuropean nations, and only if the manufacturer is actively seekingFDA approval. Experts said the intent of the current statute was toprevent manufacturers from selling defective or dangerous productsto developing nations that lack sophisticated regulatory agencies.
On Wednesday, sponsors of the FDA export reform bill charged thatcurrent laws are forcing companies to locate factories overseas andthus export U.S. jobs. Sen. Orrin Hatch (R-Utah), one of the sponsorsof the 1986 legislation that allowed export to the restricted list of 21countries, said "the FDA cannot continue to be the traffic cop forworld trade in medical goods.
"We have become increasingly concerned, even perplexed, by FDA'spropensity for regulation without commensurate gains in publichealth or safety," said Hatch. "This over-regulation costs industrymoney and it costs the taxpayers money. In a time of deficitconstraints, it makes little sense for the FDA to review whether or notcountries which wish to receive our goods can receive our goods."
But FDA spokesman Jim O'Hara told BioWorld that the FDAcurrently enforces a statute conceived and passed into law byCongress, not the agency. He argued that significant progress hasbeen made in reducing the time needed for export permit approvals,especially for unapproved medical devices. In 1993, it took theagency an average of 65 days to grant a device export permit while in1994 the average dropped to 16 days.
Nonetheless, "the export issue is an issue that we have looked at andthat we continue to look at," he said. O'Hara declined to confirm ordeny reports that the Clinton administration will include a proposal tochange current export laws in its comprehensive plan for FDAreform, due out in the next two weeks.
Although Hatch and others lauded the "bipartisan" team of legislatorsbacking the export reform bill, a list of 34 co-sponsors revealed onlyfour House Democrats. Biotechnology Industry Organization (BIO)President Carl Feldbaum told BioWorld that the dearth of Democratsmight be explained by party unity.
"The Democrats feel some responsibility to wait and see what theadministration wants to do," said Feldbaum. "But we applaud thosewho are willing to get out in front of the curve on this issue."
Feldbaum said his organization has discussed the issue of reformingexport laws with White House officials and that the talks so far havebeen "difficult and contentious." Although a number of thePresident's proposals for change at the FDA can be implemented byissuing new regulations and guideline documents, export laws mustbe changed by legislation.
The Pharmaceutical Research and Manufacturers of America(PhRMA) voiced strong support for the FDA export reform measure.PhRMA President Gerald Mossinghoff said the legislation "properlyrecognizes the sovereignty of the member nations of the World TradeOrganization, the legitimacy of other national regulatory standards,the needs of patients in other countries and the need to preserve U.S.jobs."
The bill was introduced in the House by Rep. Fred Upton (R-Mich.)and in the Senate by Sens. Hatch, and Judd Gregg (R-N.H.) n
-- Lisa Piercey Washington Editor
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