Setting standards for biologics
AS AMERICAN families face the rapidly escalating costs of staying healthy, health care industry experts and politicians each year have brought proposals to the forefront to take pressure off increasing costs. One key milestone for controlling costs was an action taken by Congress in 1984 dramatically changing the generic drug approval process. This legislation, the Hatch-Waxman bill, expanded the number of options for consumers by creating a process to move more generic drugs into America's pharmacies, saving consumers an estimated $8 billion to $10 billion a year.
There is little debate that generic drugs benefit the consumer when the process for approval is strict, closely monitored, and regulated with patient safety in mind. Generic drugs are as safe as brand-name drugs because the 1984 legislation empowered the Federal Drug Administration to ensure that generics use the same active ingredients and are shown to work the same way, producing the same benefits -- and risks -- as their brand-name counterparts. When approving generics, the FDA requires them to have the same quality, strength, purity, and stability as their brand-name counterparts to ensure that they work in exactly the same way.
Unfortunately, there are now efforts in Congress to lower those standards in regard to the emerging field of biotech drugs, or biologics. Produced from living cell cultures rather than synthesized chemically, biologics are the fastest growing component of the drug market, treating cancer, Alzheimer's, heart disease, diabetes, multiple sclerosis, AIDS, and arthritis, among many others.
Massachusetts has a distinct edge in the biotechnology field, with dozens of companies developing products today to treat and possibly cure debilitating and deadly diseases. But without the proper protections in place to ensure that these products meet the highest clinical standards and protect the intellectual property of innovator companies, we could be threatening the future of this dynamic field.
The rush by some in Congress to create a new market for generic drug makers in the field of biologics would actually sacrifice patient safety over the long term. The challenge Congress and regulators face as they seek to create a path for follow-on biologics is that the process of making biopharmaceuticals is much more complex than making chemical drugs and requires greater scrutiny and testing. Effective generic biologics would be extremely difficult to produce safely because these products are developed from complicated and diverse living organisms. The slightest change in process could render the drug useless or even dangerous. Traditional chemical pharmaceuticals simply require generic drug manufacturers to copy a scientific formula to produce the exact same result time after time.
This legislative effort may also be putting in jeopardy the very economic situation that has enabled the biotechnology field to surge in Massachusetts by lowering standards for patient safety and failing to provide proper intellectual property protection.
Companies in the early stages of developing a product rely on financial support to complete the research and development process. By jeopardizing that support, the discovery of innovative medicines could be stifled.
As Congress presses forward, legislators and regulators must take the time to understand that biologics are very different from traditional chemical pharmaceuticals and that, unlike the process for producing generic versions of chemical drugs, current scientific capabilities are not sufficient to produce generic biologics that are exact replicas of the original products.
The introduction of follow-on biologics may indeed eventually provide patients a more affordable alternative to life-saving medicines, which is a laudable goal. But given the highly complex processes involved in creating and manufacturing biologics, Congress and the FDA must be deliberative and careful before allowing generic companies to do their best to replicate proven biologic treatments. Let's move toward more affordable solutions, but do so with an approach that helps to ensure both the safety of patients and the incentives needed to help keep Massachusetts biotechnology companies in the business of creating new cures.
Una S. Ryan is president and chief executive officer of AVANT Immunotherapeutics Inc. 