A Message from Kathleen Jaeger: Congress Needs to Act Now to Approve Biogenerics

MAY 01, 2007

Congress is currently considering important legislation that could help countless Americans gain access to the medicines they need, while saving patients and the health care system billions of dollars annually. This legislation, the Access to Life-Saving Medicine Act, would give the FDA the legal authority to create a clear, efficient abbreviated approval pathway for safe and effective biogenerics. The act also would provide the FDA with the flexibility to let sound science drive the approval process to ensure safety and efficacy.

It is critical to bring biogenerics to the market because biopharmaceutical medicines, which are used to treat conditions such as multiple sclerosis, diabetes, and cancer, are extremely expensive. With some prices exceeding $200,000 per patient per year, biopharmaceuticals are inaccessible for many Americans. Health care providers, such as the California Public Employees Retirement System (CalPERS), are concerned about the high costs. In fact, CalPERS found that, on average, its spending for biotech products was at least $55 per day—compared with traditional drugs at only $2 per day. Given those costs, biogenerics could offer patients access to lifesaving treatments at an affordable price. Even a modest reduction of 10% to 25% in costs would amount to billions of dollars in savings to patients and the health care system. According to a study released by the Pharmaceutical Care Management Association, biogenerics would save the Medicare Part B program alone $14 billion over 10 years.

The Access to Life-Saving Medicine Act would bring affordable biogenerics to market, but, most important, it would bring safe and effective biogenerics to patients—biogenerics approved using advanced scientific analytical tools. Specifically, the act would ensure the safety of biogenerics by giving the FDA sole authority to determine what data and tests it needs, on a product-by-product basis, prior to approval. With more than 20 years of experience in reviewing biopharmaceutical products and the benefit of significant scientific and technological advances, the FDA clearly has the tools and know-how to approve biogenerics. In fact, the FDA has said that today's science supports the review and approval of biogenerics with low-tomodest complexity.

Scientists with expertise in biopharmaceuticals agree. Theresa Gerrard, PhD, a former FDA official and former director of development for a brand biotech company, has noted that the FDA currently reviews the data from sophisticated and advanced scientific analytical tools to assess the impact of changes made by the brand companies to their biopharmaceutical products. "These analytical tests have been deemed to be the most sensitive technologies to ensure safety and efficacy of products that are changed by the brands,"Dr. Gerrard said in congressional testimony.

She added, "Using the same scientific principles that were the basis for this current effective process for testing comparability, it is scientifically sound and practical to approve biogenerics based on a clear and efficient abbreviated approval pathway that will ensure safety and efficacy."

Similarly, Bill Schwieterman, MD, a former FDA official and consultant on biopharmaceutical products for brand companies, said, "Despite what others in this debate may have implied, biogenerics can and will be safe for patient use and may be therapeutically interchangeable. I say this because the opposition completely ignores the FDA's scientific and medical prowess in this debate. It is clear to me there is just one agency safety standard. And that standard has been, and will continue to be, applied in the review and approval of each and every biologic—whether it is a brand or generic."

Given today's scientific advances and the potential for significant savings, more than 50 diverse organizations representing tens of millions of Americans are supporting the legislation and calling on Congress to take action. These groups include AARP, the AFL-CIO, and a coalition of large national employers, health plans, pharmacy benefit managers, chain pharmacies, and generic drug manufacturers, all of which are working to promote access to safe and affordable quality health care.

The time is now for Congress to pass the Access to Life-Saving Medicine Act, and lawmakers need to know how important this issue is to patients and the health care system. Please visit www. gphaonline.org and click on the "Contact Congress"tab to urge Congress to pass this important legislation without further delay.

Kathleen Jaeger, GPhA president and chief executive officer