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Shaking Up the FDA

Executive Summary

To improve regulatory predictability, Mark McClellan has plans to reduce multiple-cycle reviews. In addition, he is in the midst of adopting best review practices and developing clearer guidances in therapeutic areas where progress has been slow and in certain emerging areas. While such plans potentially offer good news for the brand-name drug companies--though the benefits will be slow to accrue since the regulatory efficiencies will take years to fully materialize--they won't lower overall system costs since lower development expenses won't necessarily lead to lower average prices. Thus the FDA is focusing on two areas in which it has direct influence on drug costs and reimbursement: speeding the approval of generics and forcing OTC switches. McClellan's desire to impose a cost-benefit mindset on the agency attempts to balance the needs of the drug industry with the needs of reimbursers, particularly the Federal government as it prepares to shoulder the new burden of Medicare outpatient drug costs.

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Making His Mark on CMS: McClellan & Cost-Effectiveness

As the new leader of the Centers for Medicare and Medicaid Services (CMS), Mark McClellan, MD, PhD, faces two immediate priorities in implementing the new Medicare Prescription Drug Act. First, he needs to rollout the temporary drug discount card program. Second, he will oversee the promulgation of regulations to further clarify the law's meaning. But this isn't all that's on McClellan's mind. He's thinking more broadly about his opportunity to run CMS.

Making His Mark on CMS: McClellan & Cost-Effectiveness

As the new leader of the Centers for Medicare and Medicaid Services (CMS), Mark McClellan, MD, PhD, faces two immediate priorities in implementing the new Medicare Prescription Drug Act. First, he needs to rollout the temporary drug discount card program. Second, he will oversee the promulgation of regulations to further clarify the law's meaning. But this isn't all that's on McClellan's mind. He's thinking more broadly about his opportunity to run CMS.

McClellan's Balancing Act: Yes to Generics, No to Imports & Price Controls

It's hard to fault the FDA commissioner for his even-handed treatment of the two drug industries--branded vs. generic--and the competing social imperatives they stand for: new drug research and affordability. In recent speeches, Mark McClellan, MD, PhD, has been making the branded industry's case both for higher drug reimbursement from Europe and against parallel imports from Canada. And he's also been pushing for making it easier for branded generic drugs to hit the market. The only problem with this balancing act: he has far more power to quickly advance the generic agenda than the branded one.

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