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What We're Reading: Should the FDA Change How Drugs Are Approved in the US?


What we're reading, June 30, 2016: one doctor makes the case for the FDA moving away from a simple approval/no approval system; Massachusetts and Gilead come to an agreement over hepatitis C drug rebates; and Georgia considers Medicaid expansion.

In a commentary for The Wall Street Journal, cardiologist John Sotos, MD, makes the case for changing how the FDA approves drugs in the United States. He argues that the FDA should stop making decisions that are only approval or no approval and instead rate the drug’s safety, efficacy, and the degree of evidence supporting those 2 aspects. Taking such an approach would provide physicians and patients with a starting point when making decisions and it would allow drugs to reach the market faster, which could be life-changing and life-saving for patients with life-threatening diseases and no options.

Massachusetts and Gilead Sciences have come to an agreement over hepatitis C treatments. The state was threatening to sue the company over the cost of the drugs, but have reached a deal for the state to receive rebates fo most residents with the disease, reported STAT. The state is expected to save a significant amount of money under the deal where Gilead's Harvoni will be the exclusive therapy for 80% of the state's Medicaid program.

Georgia could following in Louisiana’s footsteps regarding Medicaid expansion. According to Kaiser Health News, after years of anti-expansion sentiment, Georgia is re-examining the possibility of expansion, possibly through a waiver plan. However, with 5 rural hospitals closing in Georgia since the beginning of 2013, access to care will remain an issue even if the state expands Medicaid coverage.

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