Monday, July 16, 2007

Even those of us who work on behalf of the biotechnology industry were surprised by the results of a new poll conducted on behalf of our organization: The American public has said that finding cures to debilitating diseases like Alzheimer’s, Parkinson’s and cancer is more important than combating terrorism and improving education. Clearly, in sending this message, people are speaking as much with their hearts as with their minds.

Biotechnology innovators have developed and commercialized more than 300 biotechnology drugs and diagnostics that are helping more than 325 million people living with rare and debilitating diseases worldwide. Another 370 biotechnology products are in the pipeline. But even with the dynamic evolution of our industry in recent years, which has given patients, caregivers and ordinary Americans renewed hope and promise, we have our work cut out for us.

Typically, it takes 10-15 years and an average of more than $1.2 billion to develop a new biotechnology therapy from discovery to clinical trials to the Food and Drug Administration (FDA) for review and approval. Because of the overwhelming cost and time involved, it is essential that companies have some assurance that they will be able to recoup their sizable investment, which in turn allows them to develop new therapies. To do anything less would shortchange patients facing illnesses today and those who are diagnosed tomorrow.

Congress is currently considering legislation that could greatly impact our ability to fulfill the promise of biotechnology. These proposals would enable companies to produce follow-on biologics (sometimes erroneously called generic biologics), which are products that seek to imitate pioneering biotechnology drugs and therapies. But Congress should proceed with caution — missteps on the path to developing follow-ons could undermine future innovation and future cures.

Biologics are complex organisms developed from complicated and diverse living cells and organisms. The slightest change in manufacturing processes can impact product efficacy and patient safety. Because of this complexity, a follow-on biologic is a product that is similar to, but not the same as, the innovator drug.

Despite these concerns, the legislation being considered by Congress would allow pharmacists to interchange follow-on products with innovator products without the knowledge of the patient’s physician. Allowing this type of interchangeability ignores the key differences between biologics and traditional, small molecule chemical drugs, interferes with the practice of medicine and undermines physicians’ ability to develop appropriate treatment programs for their patients.

Health and Human Services Secretary Michael Leavitt noted in a recent letter to the Senate Committee on Health, Education, Labor, and Pensions: “In light of the current scientific limitations on the ability to make determinations of interchangeability, and because it is critical to protect patient safety, the Administration believes that patients should not be switched from the innovator biological product to a follow-on biological product (or vice versa) without the express consent and advice of the patient’s physician, and legislation should not allow for determination of interchangeability at this time.”

As Congress considers follow-on biologics, it should ensure that several key principles are part of the formula. Congress must ensure patient safety because no patient should have to accept greater risks or uncertainties when using a follow-on product. It is also critical that Congress recognize and understand that there are scientific differences between chemical-based drugs and biologics, which are made with living organisms. Congress must also work to maintain the physician-patient relationship, preserve incentives for innovation and ensure transparent statutory and regulatory processes. Meanwhile, it is also important that Congress ensure that the workload associated with new applications for follow-ons not harm the FDA’s ability to efficiently review new drugs and biologics.

The introduction of follow-on biologics may indeed eventually provide patients with a more affordable alternative to life-saving medicines, which is a laudable goal. But given the complexity of biologics, Congress and the FDA must be deliberative and careful in setting standards to approve products that seek to replicate proven biologic treatments. With an eye for the future, Congress must protect patient safety and innovation today in order to help future generations.

Jim Greenwood is president and CEO of the Biotechnology Industry Organization.

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