A routine monthly meeting of the Washington, D.C., chapter ofthe Biotechnology Industry Organization (BIO) on Tuesdayturned into a rousing discussion of President Clinton's draftplan for health-care reform and its potential impact on thebiotechnology industry.

When BIO's scheduled speaker for the day, Greg Simon -- vice-president Al Gore's domestic policy adviser and point man forbiotechnology -- canceled fifteen minutes before the meeting,the FDA's acting associate commissioner for legislative affairs,Jerry Mande, served as pinch hitter.

Mande was left to defend the president's draft health-carereform package after following BIO's vice president ofgovernment relations Chuck Ludlam to the podium. Ludlamroundly criticized the plan's drug pricing policies. (The mostrecently leaked draft of the plan includes expanded powers forthe secretary of Health and Human Services (HHS) overprescribing practices, required rebates from companies forMedicare and Medicaid drugs and the establishment of anational health board that could blow the whistle on overpriceddrugs.)

"The tragedy is that (these provisions) focus on breakthroughdrugs," said Ludlam, "which means we have an industrial policythat discourages investments generally, and especially (drugsfor) the elderly."

Ludlam added that there was still time to modify the reformpackage prior to the president's formal announcement of theplan, scheduled for the evening of Sept. 22. Following that,there would be even more opportunities for modification as thepackage winds its way through Congress.

Mande urged the biotech industry to continue working with theadministration. "I think this is a very open process," he said."There is a reservoir of goodwill for your industry."

Mande said support was quite strong for biotechnology inCongress, and that "the first thing they think about is thepotential the industry has for the economy. They don't want tosee it go the way that microelectronics has gone (overseas)."

One problem Mande addressed was that under the currentoutline, Medicare giveth, but Medicare taketh away. Therewould be drug benefits under the program but the secretary ofHHS could blacklist drugs deemed too costly. "There needs to besome way (access to drugs) does not become an open run onthat trust fund," said Mande.

Ludlam circulated a letter to Clinton from BIO president CarlFeldbaum at Tuesday's meeting. The letter requested thatClinton "not single out introductory drug prices for specialreview or regulation."

"These proposals only perpetuate the cloud of uncertainty thathas plagued America's biotechnology industry for months,"Feldbaum wrote. "The ongoing discussion of price controls andjawboning has already had a very serious impact on theavailability of capital for our research. "

-- David C. Holzman Washington Editor

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