How Healthcare Legislation Can Ensure Patient Safety and Spur Innovation
Next week, the U.S. Senate is expected to take up debate on health care reform. Regardless of what happens in Washington DC, the impact will be felt on virtually every business and individual in Washington State.
Without question, a simple solution to our health care crisis is elusive, and in the coming days and weeks many complicated and important issues will be debated, but from where I stand today, there is one key health care issue with no room for debate.
The issue is the development of a pathway for regulatory approval of biosimilars by the Food and Drug Administration (FDA). Biosimilars, as the name implies, are drugs that are similar to, but not the same as, innovator biologics. Biologics are molecular structures that can be hundreds of times more complex. That’s why copycat versions of biologics aren’t called “generics.” Biotechnology-based therapies that fight diseases such as cancer, diabetes, and Alzheimer’s are made from living cells—a process far more complex than the one used to manufacture chemical-based drugs such as aspirin.
The illustration below helps to put into perspective the differences between small molecule drugs and biologics:
To give a sense of size, same-scale computer models of three drugs—aspirin (a small molecule), somatropin (human growth hormone), and Herceptin (an antibody)—are presented as an example of the relative complexity: The molecules are to scale and the objects are not, but the objects (bike, car, private jet) indicate relative size and complexity of these molecules. Used with Permission. Source: Genentech
Here in Washington State, we are fortunate to have great leadership on this issue from Representative Jay Inslee (D, WA-1). Rep. Inslee is one of the lead sponsors of the Pathway for Biosimilars Act (H.R. 1548), bipartisan legislation that protects patient safety and strikes the appropriate balance between increasing competition and maintaining our nation’s status as the world’s leader in science and innovation.
Rep. Inslee wants to make sure that biosimilar manufacturers are required to provide the FDA with clinical data on the safety and efficacy of their medicines. And his legislation preserves incentives for continued biomedical innovation by providing 12 years of data exclusivity to the developer of the innovator biologic. This period of exclusivity protects the developer’s intellectual property and investment, which allows companies to reinvest in R&D to develop new treatments and breakthrough therapies.
According to a recent study, more than 100 new medicines are currently in development by companies with a presence in Washington state. If they make it to market, many of these drugs will combat the leading causes of death in Washington and the United States, including heart disease, cancer, stroke, lower respiratory diseases, Alzheimer’s, diabetes, influenza, pneumonia, nephritis, septicemia, and liver disease. Others will fight diseases that Seattle’s vibrant global health community is tackling head on, such as HIV/AIDS, tuberculosis, and pneumonia.
Lawmakers also must make sure that the biotech industry continues to receive the financial incentives necessary to support the research and development of new biologics, which require billions of dollars in investment, research, and production. Recent data suggests that it costs nearly $1 billion for a new therapy to make it to market, and only one new drug approved out of the three will recover the cost of research and development. In addition, it can take as many as 16 years for a drug to recoup the investment made to bring it to market. Only one out of three approved drugs eventually make a profit. Unless biotech firms are able to recoup the investments made in adequate sales and receive a return on their investment, financing for biologic research will dry up, biotech firms will fail, jobs will be cut, and future innovation will be stifled. Additional potential casualties are patients that otherwise would have benefited from the promise of a new drug that never makes it to market due to a lack of investment dollars as a result of legislation that does not preserve continued incentive to innovate and develop new therapies.
Such a downturn would hit Washington particularly hard. There are 140 biotech companies currently in Washington; this is a $10.5 billion-a-year business directly employing more than 20,000 residents, while more than 67,000 Washington residents’ livelihood is dependent on the biotechnology industry.
It is vital that we keep biotech innovation alive in Washington State because we are one of the top recipients of National Institute of Health (NIH) funding as well as venture capital investment. These funding sources go largely to investments in human biotechnology, medical therapeutics, and the pharmaceuticals sectors. These sectors would be the hardest hit if irresponsible biosimilars legislation became law.
Another potential “side effect” of biosimilar legislation that does not preserve continued incentive to invest in innovation may be that the federal government may have to become the new “investors” in biologic drug development. In the advent the private sector no longer has incentive to invest in new drugs or biotech companies, and if we hope to advance new biologics into the clinic, and eventually to patients, taxpayers may ultimately have to pay for innovation.
It is my sincere hope that Senators Patty Murray and Maria Cantwell follow Rep. Inslee’s lead and champion his legislation’s principles in the Senate to set appropriate standards for the approval of biosimilars. These standards must protect patient safety while also encouraging research that helps bring new, more advanced treatments—and even cures—to patients in Washington State and around the world.
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