MM: What is BIO's focus in 2002?
Feldbaum: BIO's first order of business is to renegotiate the Prescription Drug User Fee Act, or PDUFA, with FDA and Congress. Enacted in 1992, along with the Food and Drug Modernization Act, it streamlined biologics' review path through FDA. BIO is proposing an increase in user fees so FDA can implement more risk management initiatives, improve communication between companies and the agency during the first cycle of review, enhance performance of the review process, and offer independent consultants to help sponsors design Phase III clinical trials.MM: How does BIO hope to influence the Senate's upcoming vote on anti-cloning legislation?
Feldbaum: Like death and taxes, the cloning debate is inevitable. We are prepared to take on those who want to squelch research in somatic cell nuclear transfer and the use of cloning technologies for therapeutic purposes.
In the meantime, we are holding conversations with religious leaders of various denominations to discuss cloning and stem cell research-and we are prepared for a very long haul. The Vatican decided in 1869 that life begins at conception. So we are working with Catholic bishops to re-examine that decision in light of what we now know about reproductive biology. Those religious leaders will participate in our 2002 annual meeting in Toronto this June, both as plenary speakers and as participants in bioethics seminars.
MM: What is your relationship with PhRMA?
Feldbaum: We work closely with PhRMA to make sure that our individual policies don't collide and that our efforts, to the extent possible, don't conflict on Capitol Hill, because a number of companies are members of both organizations. We construct and execute our own agendas, which are often quite similar, but our priorities tend to be different because BIO is made up largely of small, emerging companies deeply involved in R&D, many of which do not yet have products on the market.
MM: How does BIO attract investors into the sector?
Feldbaum: We take a somewhat unorthodox role for a Washington-based trade association in that we interface between investors and the biotech community. We host meetings around the world that involve partnering between pharmaceutical and biotech companies and, increasingly between biotech and biotech. We also hold investor meetings to highlight new or very promising areas of research, such as regenerative medicine, that may not have received the investor attention they deserve.
The BIO & CEO Investor Conference 2002 in New York was our largest yet. The meeting really got back to basics, focusing on cancer therapeutics, anti-infectives, and monoclonal antibodies-the core technologies of our industry. Last year's meeting was more a "flavor du jour," with genomics, proteomics, and bio-informatics on the agenda.
Since September 11th, there has been strong interest in increasing interaction between the biotech and national security communities. That's a theme you will see develop throughout 2002 and beyond.
MM: Is BIO reaching out to other audiences?
Feldbaum: BIO is now engaging the judiciary branch of the government with its website Biojurist.org, which will launch in May. It will initially focus on helping judges, law clerks, law librarians, and legal academics engaged in biotech-related intellectual property issues. We will expand the website to include other issues, such as genetic privacy, that are percolating through the federal judiciary.