Senior Staff Writer

TORONTO - BIO 2002 is an unmatched opportunity for those involved in the sector to mingle, network, press the flesh and generally discuss the topic that brought the masses here: biotechnology. It also is the grandest stage in the industry, and provides instant access to the ears of the most revered names in the business.

Calling the Biotechnology Industry Organization's 2002 International Convention & Exhibition "the largest conference of this type ever in the world," U.S. Department of Health and Human Services Secretary Tommy Thompson used that stage to detail the Bush administration's stand on several hot topics during the opening breakfast plenary session.

Addressing a sizable, early morning crowd, Thompson briefly touched on "some of the largest areas on the horizon for my department" - stem cells, FDA policy, the Prescription Drug User Fee Act (PDUFA), and the modernization of Medicare.

With President Bush's decision to allow research on 72 approved stem cell lines, Thompson said, researchers are "already beginning to realize the tremendous promise of stem cells," especially in the areas of Parkinson's disease, multiple sclerosis and various cancers.

Although a full-time FDA commissioner has not been named, Thompson said he and newly appointed FDA Deputy Commissioner Lester Crawford "share a bold new vision for the FDA." That vision includes structuring a risk-assessment program that "will be integrated into all the FDA centers," he said. (See BioWorld Today, Feb. 28, 2002.)

"You will not recognize the FDA a year from now," Thompson told the crowd.

Also, Thompson said, he is against the mandatory labeling of genetically engineered foods, saying it would be "costly to both the industry and consumers. Mandatory labeling would only alarm consumers. It seems to imply bio-engineered foods are unsafe."

Near the end of May, the House and Senate passed bioterrorism legislation by a combined 593-to-1 vote. That piece of legislation had a new PDUFA tacked on and is scheduled to be signed this week, something Thompson called "good news for everyone in this room." (See BioWorld Today, May 28, 2002.)

"[PDUFA] will be stronger and more effective then ever," he said. "Both consumers and companies like yours will benefit from it."

Additionally, Thompson said that "President Bush is committed to the comprehensive modernization of the Medicare program," adding that the Bush administration is "absolutely committed to providing seniors with affordable drugs." However, "opening up the borders" to cheaper prescription drugs in Canada is "a risk we cannot take."

Thompson instead pointed the finger at pharmaceutical companies, imploring them "to do more to bring down the pricing of drugs."

Just before 11 a.m. Monday, BIO Chairman David Robinson and Canada's Minister of Industry, Allan Rock, officially opened the exhibit hall with a ceremonial red ribbon cutting. The event included band members from the Royal Canadian Mounted Police, who played loudly enough to bite into the auditory fervor of gathered attendees glad-handing and chatting - a constant noise in the busy hallways and thoroughfares of the Metro Toronto Convention Centre.

With the ribbon snipped, the doors were opened to the "almost 14,000 delegates, 45 countries and more than 1,000 booths," that make up this year's exhibition hall, Rock said.

At the plenary luncheon, BIO President Carl Feldbaum stood before a packed house to discuss a biotechnology foreign policy.

"It's time we had one," Feldbaum said, his image blown up and thrown onto five large screens behind him. "We need one now to decently and properly position our industry for the future. One that is cognizant of the miserable choices other industries have made and avoids them."

Feldbaum listed ten "modest, overarching principles." Among other things, he suggested the industry work with government and institutional bodies to better respond to public health crises. He called for an orphan-drug program for diseases of the developing world. And he said leaders should be "seriously considering" agricultural biotechnology as part of nutrition programs in the developing world.

Feldbaum also said biotechnology should be used for treatment and protection against bioterrorism, but never used to develop weapons. The government needs to respect biotechnology-based intellectual property, he said, and international and national regulatory regimes should be clearly based on science.

For those "prospecting" for biotechnology leads around the globe, the cultures and indigenous groups of the areas must be treated fairly and respectfully, Feldbaum said. Also, consumer markets "should be open for safe and effective biotechnology products," and products should not be "hijacked" on the marketplace because "of anti-American sentiments."

Commenting on his outlined principles, Feldbaum said, "there is really little foreign" in them.

"We are all in this great endeavor together," he said. "I believe we are wise enough to learn from other industries and get our international responsibility right this time. I sure as hell hope so."

The convention continues through Wednesday.