A pathway for new medications
THE LATEST salvo from Congress in the battle over drug prices is legislation introduced by Senator Hillary Clinton and others that would create a legal pathway for approval of "follow-on biologics" -- newer versions of biological products currently on the market.
Insurers, generic drug companies, and others see these products as a way to stimulate competition and reduce costs. The industry sees approval of follow-on biologics, which are more complex than traditional chemical compound pills, as unsafe without clinical trials.
There should be a pathway for follow-on biologics that will bring the benefits of biotech research to patients as soon as possible. But such is the way in Washington that the players involved see everything in political and self-serving terms. The best policy approach would be to allow science and patient care to guide our way forward.
Good patient care demands that manufacturers show that their products are safe and effective before they are allowed on the market. For biologics, including the follow-on type , the only way to demonstrate this is through clinical trials -- though follow-on biologics should be on an expedited track. This should be required by law. Determining the size and extent of the trials required for each new product should be left to the scientific experts at the FDA.
Just as it's important to ensure that new versions of biotech drugs get to the market, it is essential to maintain incentives to innovate. The original Hatch-Waxman bill, which opened the first pathway for lower-cost generic version of drugs,also provided new market protection for the pioneering companies. A similar balance should be struck for biologics.
Although the debate over follow-on biologics has recently become front page news, it has actually been going on for several years. During that time, technological and scientific advances have shown that biological products can be brought to market more efficiently while maintaining the highest standards for safety and effectiveness. A follow-on biologic legal pathway would spur even more of these developments. My own company is already developing a new technology that could reduce manufacturing costs of biologics.
Congress can and should develop a pathway for approval of follow-on biologics. Guided by science and patient care, this program should require manufacturers to perform essential clinical trials , though not the full phase I-II-III trials for new biologics , and to contain appropriate incentives for innovation. It should also encourage development of new ways to bring products to market more cheaply.
Patients don't need politics, they need the health benefits the biotech industry can bring them. The industry should, as it always has in the past, support scientific innovations, including those inherent in developing follow-on biologics. A balanced policy will get us all there.
Dr. James A. Bianco is president and CEO of 
