Lawmakers have proposed 'witch's brew' of biotech bills

Lawmakers in recent months "have stirred up a witch's brew of initiatives that is cause for some concern -- not only for the biotech industry, but for all Americans," James Mullen, president and CEO of Biogen and chair of the Biotechnology Industry Organization, writes in a Wall Street Journal opinion piece.

"What will the next 30 years mean for our industry and the patients we serve?" Mullen writes, adding, "The answer will depend in large measure on what happens in Washington over the next two years."

According to Mullen, legislation that would allow the HHS secretary to negotiate prices directly with pharmaceutical companies under the Medicare prescription drug benefit "would inhibit our efforts to turn new scientific tools and pathways -- such as those emerging from the Human Genome Project, stem cell research, and information technology advances -- into real medicines to help patients in need." In addition, legislation that would implement "tougher drug safety laws and an overhaul of FDA oversight" is unnecessary, Mullen writes, adding that "a very careful balance has existed at the FDA for decades that looks at the benefits and risks of potential treatments to determine if they should be approved." He adds that "Congress should step back and move very thoughtfully on any legislation concerning generic versions of biotech drugs" because "getting this wrong could result in reduced R&D spending, or possibly unsafe drugs being pushed through a scientifically flawed regulatory process."

Mullen writes, "Directly or through our families and friends, we will all face death from cancer or a rare genetic disorder. Or the frustration of Alzheimer's or Parkinson's diseases. Or an MS relapse that may put us in a wheelchair for the first time." He concludes, "What Congress does and does not do over the next two years may well impact the future of biotechnology -- and all of us -- for decades to come" (Mullen, Wall Street Journal , 4/27).