WASHINGTON - The Biotechnology Industry Organization proved itself a force in Washington on the opening day of its 10th annual convention when it introduced President George W. Bush as a lunchtime speaker.
And for Bush, the speaking engagement was the perfect opportunity to look for support on a few controversial issues that directly impact the biotechnology industry.
Right after thanking Carl Feldbaum, president of the Biotechnology Industry Organization for inviting him, President Bush asked the biotechnology community to lobby Congress to pass Project BioShield, the administration's initiative designed to speed the development and availability of medical countermeasures in response to current threats. The project was designed to streamline government research, create incentives for companies and give the government the ability to make products widely available in a public emergency. (See BioWorld Today, March 28, 2003, and April 7, 2003.)
Bush told the audience he proposed spending nearly $6 billion over the next 10 years to develop vaccines against nasty illnesses and agents like smallpox and anthrax, botulin toxin, Ebola virus and other possible bioterror weapons. (Project BioShield has made it through committees in both the House and Senate.)
"The biotechnology industry finds itself on the front lines of some of the great challenges of our time. The first challenge is the need to fight terror," Bush said. "All of us know the great possibilities of modern science, when it is guided by good and humane purposes. We understand, as well, the terrible harm that science can do in the hands of evil people."
Indeed, Bush said the country's enemies have ambitions to acquire and use biological, chemical and nuclear weapons. "The most direct way of removing threats to our country is to eliminate them at their source. And that's what the United States of America has done and we will continue to do by waging a focused, relentless effort to hunt down any terrorist that would harm the United States of America and our citizens."
Those statements produced plenty of applause for the president, who also encouraged the audience to stand behind him in his opposition to the European Union's five-year moratorium on approving agriculture biotechnology products. (See BioWorld Today, May 29, 2003, and May 19, 2003.)
"Acting on unfounded, scientific fears, many European governments have blocked the import of all new biotech crops," Bush said. "Because of these artificial obstacles, many nations avoid investing in biotechnology, worried that their products will be shut out of important European markets."
In late May the Bush administration filed a dispute within the World Trade Organization against the EU's moratorium. Both the House and Senate have passed resolutions in support of the administration's move.
Too bad the Medicare and prescription drug issues can't be resolved with supportive resolutions. Raising the issue, Bush said medicine has dramatically advanced over the years, but Medicare hasn't. The current system, he said, was designed at a time when hospital stays were common and drug therapies were rare.
The government has a responsibility to improve and strengthen Medicare by making modern medicines an integral part of the Medicare system, including drugs for seniors, he said.
"This is a goal you have supported for several years," Bush said. "And if we finally put aside partisan politics and focus on what's right for American seniors, I believe we can achieve the goal this year."
FDA To Raise Performance Standards
FDA Commissioner Mark McClellan has his own plan for helping develop innovative products at a reasonable price.
"The bottom line is to reduce the overall time for development and approval of safe and effective drugs," he said.
Taking the podium after Bush, McClellan gave the audience a preview into new guidelines aimed at slashing the overall FDA review time by 10 percent.
Also, he said the agency wants to do its part in reducing the uncertainty associated with the drug and biologics business by working with companies to cut down on application cycles. "We want to get it right the first time," said McClellan, noting that companies often must submit amendments containing new or additional trial data after an original application is filed. Those are the types of hurdles that can stall drug development for years.
McClellan estimates that it costs about $800 million and a decade of work to get a drug to market. But just as important, he said most drugs or biologics never make it to market because they fail in the clinical-trial process.
According to McClellan, last year 12 new biologics made it to market, down from 27 in 1998.
The agency will meet its June 30 deadline for transferring therapeutic product reviews from the biologics center to the drug center. The decision to consolidate was made last summer in a move to speed approvals and streamline certain aspects of government.
Earlier Monday, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, said while it is unfortunate, bioterrorism may end up being the catalyst to important collaborations.
The lifeblood of the biotechnology industry, collaborations bring different ideas to the table, often speeding development.
And in this era of re-emerging and emerging diseases, clearly it has become more important for the industry, academia and the government to work together, he said.
Take SARS, or severe acute respiratory syndrome, for example. As of Friday Fauci said there have been 8,500 cases and 804 deaths worldwide. "Next winter we may find ourselves trying to distinguish between SARS, influenza and other upper respiratory diseases," he said. "We will need the capability to diagnose it quickly."
While that is true for SARS - a disease of nature - it's also true for bioterrorism agents.
But what will clearly be different about bioterrorism is the amount of money the Bush administration is willing to spend to control it. (The administration estimates that BioShield would cost $6 billion in 10 years, but actually it has requested unlimited mandatory funding from Congress.)
Nevertheless, Fauci said that BioShield will result in more than just research. "In five to 10 years we won't say, this is what we've learned - but we'll have something to show for it."
Proposed bioterrorism research funding for 2003 is a shade under $1.5 billion, up from $274.5 million in 2002, Fauci said.