Regulatory uncertainty mires breakthrough drugs

From The Hill’s Congress Blog, November 24, 2015

by Amanda Conschafter and David Charles, M.D.

Food labels now cater to consumers who are as hungry for data as for, say, potato chips. A quick glance at your snack’s packaging can tell you whether it’s organic, vegan, GMO- or gluten-free, or if it was packaged in a factory that also processes peanut, tree nut or wheat products. Consumers want transparency about what they eat.  It should come as no surprise that physicians and patients want the same with the medications they prescribe.

Yet the issue of transparency in prescription drug labeling, testing and naming has given rise to debate in recent years, specifically related to biological and biosimilar drugs. Biological drugs are the breakthrough medications developed from living cells or tissue that change lives for rheumatoid arthritis, multiple sclerosis, cancer, migraine headache patients and others.  Biosimilars are follow-on biologic medications, which many hope will offer similar results at lower prices.

But there’s a snag…. Read more

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