The FDA is flexing its muscles

Prognosis

Biotechnology companies often have both devoted fans and detractors. But there's one constituency they'd be wise not to anger: U.S. regulators.

In the past few weeks, the Food and Drug Administration has dropped the hammer on pharmaceutical giants and biotech upstarts alike. The agency slammed Novartis for manipulating data and rejected what would've been Sarepta Therapeutics's second drug for a rare form of muscular dystrophy. A company that makes a fish-oil pill caught investors by surprise when it said the agency wanted a closer look at its data. Another had a jet-lag drug rejected after the FDA said its clinical merits weren't clear.

While the details vary, the lesson is clear: Don't mess with the FDA.

The FDA has powerful sway over the pharmaceutical industry for a good reason—regulators must make sure drugs are safe and effective. Their job isn't easy. They have to balance the needs of desperate patients who want drugs now with ensuring that the science is sound. Billions of dollars invested in research ride on the decision to approve a drug.

Drugmakers have been given a lot of leeway. Last year, the FDA approved more new treatments than ever—and came under fire from skeptics who said some therapies were cleared too quickly on too little good evidence.

The agency's recent pushback shows that companies shouldn't confuse its willingness to engage with the industry for a free-for-all. There are limits. And biotech would be wise not to push them.—Rebecca Spalding

Here's what else we're watching:

The Zolgensma effect. Novartis's $2.1 million gene therapy for a harrowing disease in young children is bringing out the best and the worst in America's health-care system. Here's how parents are fighting to get it.

Animal spirits. Elanco sewed up a deal to buy the animal-health business of German drug giant Bayer, which has been bolstering its reserves as it fights claims that the weed killer Roundup causes cancer.

Pain pact. Endo International agreed to pay an $11 million settlement to end two closely watched opioid lawsuits brought by stricken towns in Ohio. The deal may foreshadow more such accords in a larger legal fight.

Gene machine. Pfizer said it will expand a gene-therapy manufacturing facility in North Carolina, as the drugmaker ramps up efforts to develop more of the revolutionary but pricey treatments. It will add 300 jobs.

Listen up. Season two of our podcast explored what happens when we hand over our health data to companies and governments. Download it here on Apple devices, and here on Android.

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We want to hear from you. If you have feedback, questions or potential story ideas, reach out to me at rspalding@bloomberg.net

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