We Must Utilize Caution When Approving Biologics

The rush to open a new regulatory pathway for the Food and Drug Administration (FDA) to approve generic biologics creates a monumental regulatory challenge that should not be a race to cut drug costs alone, but one that also includes a careful effort to protect and promote innovation in the marketplace while still ensuring patient safety.

Biologics are the skyscrapers of the drug world. They are towering monuments to medicine, science and biotechnology that can’t be duplicated without exact blueprints and precision engineering.  Allowing drug makers to duplicate these giants will create an unprecedented regulatory and safety challenge for the FDA.  If Congress grants that authority in haste, the results could be disastrous.

Biologics are protein-based, highly-engineered drugs derived from a complicated process. Biologics in common use today include: Humulin, a replacement insulin for diabetics; Procrit, an anemia treatment for cancer patients; and Avonex, a therapy for persons with Multiple Sclerosis.

Biologics are making it possible for thousands of Americans to live productive lives, while others are changing the way we treat deadly diseases like cancer and infectious diseases.  We need to move diligently and earnestly, but we must not short-circuit safety, leave patients at risk or sacrifice protections that will encourage the drug industry to innovate.

We must take time to fully consider a range of framework options for allowing generic biologics, such as the European model for follow-on, or generic, biologics. The system already adopted in Europe created an abbreviated approval pathway for biologic drugs but also required due consideration of safety, innovation and savings while also leaving decisions about critical scientific issues to scientists.

We cannot link biologics legislation to the package of FDA-related bills currently being prepared by the HELP Committee, including the “Enhancing Drug Safety and Innovation Act,