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February 27, 2012 Regulatory Affairs

Innovation vs. Safety: Another Definition for the “Chicken or the Egg”

We all know that the FDA’s mission is to promote and protect public health. However, in their effort to protect the public health, it seems that they may be inadvertently harming the industry that develops new drugs and therapies. Despite the adherence to PDUFA-mandated review timing, in recent years, the number of new drug approvals has been flat and the biopharmaceutical industry has laid the blame for this on the FDA. Because of some recent drug safety controversies, the Agency has increased its focus on drug safety and efficacy. The resulting increase in the number of regulatory hurdles has resulted in increased development time, cost and the palpable uncertainty of new drug approval. This has made investment in new drugs riskier. Without investment, the biopharmaceutical industry is slowing down innovation that is essential to finding new and better treatments for patients. Investors and senior management in companies within the biopharmaceutical industry believe the FDA must make changes to allow for more innovation.

So what’s the FDA’s story? Well, on the other side, it is becoming more difficult for the FDA to promote public health. Fewer drugs submitted for approval results in fewer drugs available to patients in need of new treatments. FDA says that their process for drug approval is still faster than in other countries, but the reason the number of new drug approvals has been flat is due to new scientific challenges, specifically in drug safety. All drugs have benefits that must be weighed against the risk of serious adverse reactions. FDA is hoping new research techniques will help make this risk-benefit decision easier. If FDA has a better way to gauge safety and efficacy, then the regulation process will run smoother and faster for everyone involved.

The FDA’s challenge is to have greater drug safety without sacrificing the speed of the review process. If this challenge can be achieved, the growth of innovation would be stimulated. The biopharmaceutical industry believes the FDA’s mission should include promoting the advancement of innovation that supports public health. By doing this, the FDA will have to keep in mind that the decisions they make have far reaching consequences into the biopharmaceutical industry. Even without an expansion in their mission, the FDA is already trying to find new ways to promote innovation and update the regulatory process to accommodate new advances in science and drug therapies.

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