Congress is considering legislation that would make it easier for the Food & Drug Administration to approve generic versions of expensive biotechnology drugs. It is hoped that this will foster competition and significantly reduce drug spending, just as generic versions of conventional drugs have done. So what exactly are biotechnology drugs, and why aren't there generics for these medications already?
There is a significant difference between a typical prescription drug, like penicillin, and a biotechnology drug. Standard prescription drugs usually work through chemical reactions to achieve the desired result. Biotechnology drugs, on the other hand, are made from actual biological material, like proteins or antibodies, and consist of very large, incredibly complex molecules that are often folded and twisted in unique ways that are difficult to duplicate. Many of these drugs are very expensive because they are so difficult to produce.
Patients and providers are sure to appreciate any effort to reduce the cost of these medications. However, the rules that the FDA has in place governing the manufacture of generic versions of standard prescription drugs are inadequate to ensure that generic biotechnology drugs are safe and function in a way that is bioequivalent to the brand-name drug. Even a small change in the way these drugs are manufactured could cause patients to become seriously ill, or possibly even die.
Scientists must perform more extensive testing to determine whether a generic biotechnology drug can safely be substituted for the brand-name. However, the demand for medication at a lower cost is forcing the government to find a way to push generic biotechnology drugs to market more quickly. This is the dilemma and debate facing our leaders - at what point are we sacrificing patient safety to keep costs down?
