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Senator Marco Rubio’s essay criticizing the FDA for failing to approve eteplirsen, an investigational drug for Duchenne muscular dystrophy made by Sarepta Therapeutics, highlights a glaring misunderstanding of the drug approval process. Public appeals like Rubio’s and those made by Duchenne families are perfectly appropriate and make for interesting public theater. But they have essentially zero effect on the FDA’s decision-making cascade. As a former FDA medical officer and senior medical analyst, as well as a former investigational medicine research scientist at Pfizer, I don’t always agree with the regulatory decisions the FDA makes. However, I do support the time-tested process for approving new drugs. (David Gortler, 6/2)

The U.S. healthcare system isn't sustainable in its current form with increasing prices, and the disparate approaches to care across states, hospitals, doctors, insurance companies, and income. Americans receive relatively poor care for their billions of dollars spent, as judged by several metrics comparing our nation with others. The high cost of health care is such a threat to the future economy that it has united our three radically different candidates for president. Donald Trump, Hillary Clinton and Bernie Sanders all agree on one strategy to help fix it: they want to allow the government — specifically the Centers for Medicare & Medicaid — to directly negotiate drug prices with pharmaceutical companies. (Stephen Brozak, 6/6)

Move over, Big Pharma. Big Biotech is coming for you. As drug developers and investors from around the world gather in San Francisco this week for the annual BIO International Convention, a new look at the biotech industry shows the biggest players are starting to behave more and more like pharmaceutical giants. There are 17 biotech companies in the US that generate more than $500 million per year in revenue. And they’re increasingly focused on buying innovative new products through mergers and acquisitions, rather than developing them in house, according to a report from EY (formerly Ernst & Young) released Monday. (Mehana Keshavan, 6/6)

Seen as a narrative of soulless profiteers versus innocent, needful patients, the crisis of high pharmaceutical prices has produced a convenient gallery of villains: the board of Gilead Sciences, for instance, which priced its hepatitis cure at what it thought the market would bear (nearly $100,000); Martin Shkreli, for another, whose Turing Pharmaceuticals bought the rights to an existing drug used by HIV patients and jacked up its price 5,000%. (Michael Hiltzik, 6/1)