Over the last month, FDA Matters has covered a wide-range of FDA-related topics: the agency, industry, and Congress, as well as medical innovation, user fee reauthorization legislation, food safety and post-market surveillance. The response has been great: FDA Matters has many new readers and I received a number of interesting questions. Today’s column touches on biosimilars, Hatch-Waxman, user fees and FDA management. Keep the questions coming!

If you are in the business of developing biosimilar products—or thinking about it—then you have to read all three guidance documents published by FDA on February 9, 2012. They provide essential (but not complete) instructions for how to construct and implement a biosimilar development plan. For everyone else, FDA Matters is providing the short version. Why take an interest? Because over the next 5 to 15 years, biosimilars are going to dramatically transform the marketplace for biological products, creating new winners and losers. Also, these new rules are going to lead to new, groundbreaking medicines…and not just less expensive versions of old ones.

There is no one answer to the question: what is the state of FDA-industry relations? FDA Matters hears some say: FDA does what industry asks it to do, the agency is a puppet. Others say that FDA is obstinately blocking industries’ path to new, better and innovative products. Yet others say FDA is misguided at points, but well-intentioned and most often right. The state of FDA-industry relations turns out to be particularly important in 2012. As part of the user fee reauthorization legislation, Congress will be faced with non-user fee amendments affecting every aspect of FDA’s mission, programs and decisions. Industry will be advocating for some; trying to block others, based in part on its relationship with FDA.