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But now, the Food and Drug Administration is considering whether bombarding consumers with every last potential side effect might be overkill. The agency, which approves prescription drugs and oversees how they’re marketed, is proposing a new study to look at whether patients are being “over-warned” to the point that they stop paying attention...The United States and New Zealand are the only two countries to allow direct-to-consumer ads on TV. It’s big business: Drug companies spend about $5 billion a year on advertising, and a huge chunk of that is on TV. But federal officials strictly scrutinize those ads to make sure they strike a “fair balance” between the benefits of the drug and the side effects. (Thielking, 6/28)

Nolan and Jack Willis, twins from upstate New York, and just 10 other boys took part in a clinical trial that led to the approval last fall of the very first drug to treat their rare, deadly muscle disease. Now the Willis boys are again test cases as a different type of medical question comes to the fore: whether insurers will cover the controversial drug, Exondys 51, which can cost more than $1 million a year even though it’s still unclear if it works. (Thomas, 6/22)

President Trump spent the last several weeks blasting Democrats for refusing to work with Republicans on health care. Now, two of the Democrats who have shown the most willingness to work with him on one specific health issue ― drug pricing ― are blasting him back. Reps. Peter Welch of Vermont and Elijah Cummings of Maryland made headlines when they agreed to meet Trump at the White House in March to discuss efforts to bring down drug prices, even as many of their colleagues worked to distance themselves from the president. The pair came away from that meeting optimistic about Trump’s willingness to press for relatively liberal changes, like allowing the importation of drugs from Canada or letting Medicare negotiate drug prices. (Mershon, 6/23)

Several items in a draft version of a White House executive order on drug pricing are causing consternation, but some Democratic lawmakers are especially upset the Trump administration seeks to weaken a program that offers discounts on medicines to hospitals. The 340B Drug Discount Program, as it is known, requires drug makers to offer discounts of up to 50 percent on all outpatient drugs — for everything from AIDS to diabetes — to hospitals and clinics that serve indigent populations. (Silverman, 6/23)

High drug prices are a constant consumer complaint about health care. Judy Woodruff sits down with Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, at the Spotlight Health Conference at the Aspen Institute to discuss the Senate Republican health care bill, the prospects for lowering drug prices and the connection between the opioid crisis and the industry. (6/23)

The FDA just took a step that could increase competition and prevent price gouging on drugs that seemingly jump in price overnight. In May, Food and Drug Administration commissioner Dr. Scott Gottlieb said he wanted to make it more difficult for drugs that are off patent to jack up the price of the medication because they don't face any competition. The biggest example of this was Daraprim, a decades-old drug that then-Turing CEO Martin Shkreli increased in price from $13.50 to $750 a pill. To keep that from happening in the future, the FDA on Tuesday published a list of more than 200 drugs that have fallen off patent where the FDA hasn't received any applications for a generic drug version of that drug. (Ramsey, 6/27)

Ayear ago, a widower caused a stir by writing in an opinion piece that advertising for a Bristol-Myers Squibb cancer drug was “misleading and exploitive.” His wife had recently passed away from lung cancer after being treated with the company’s Opdivo medicine, and he argued that Opdivo ads overstated the chances of living longer. Concerns about drug advertising are hardly new, but his op-ed, which appeared in The New York Times, triggered a fresh round of debate. Why? Opdivo is one of the new so-called immunotherapies, which harness the body’s own immune system to attack tumors. And they are transforming cancer care, raising expectations among investors, doctors and, especially, patients. (Silverman, 6/23)

Among many things the Senate bill would do is roll back a tax increase agreed to by the pharmaceutical industry at the time Obamacare was approved with the understanding that health-care coverage, and thus expenditures for drugs, would increase. The Congressional Budget Office, in estimating the financial impact of the latest bill, said the resulting tax break for pharmaceuticals over a decade would be $25.7 billion. (Johnson, 6/27)

From 2010 to mid-2015, drug stocks soared to record heights on the back of massive mergers and seemingly boundless optimism. Then, throughout the 2016 election campaign, worries about political pressure to lower drug prices put biotech stocks in a prolonged slump. (Nisen, 6/22)

If you’ve been following all things biotech, you know this has been a very good week for the industry. Stocks are up sharply across the board. Indeed, the sector is enjoying its best run of the year. In the past week, six of the 10 top performers in the S&P Healthcare Index were large-cap biotech stocks. Shares of Celgene (up 10 percent), Regeneron Pharmaceuticals (up 11 percent) and Vertex (up 8 percent) have all reached new highs. Biogen is up 9 percent, too. (Feurstein, 6/22)

Martin Shkreli is infamous. That’s making it tough to find a jury of 12 for his criminal fraud trial in Brooklyn, where he’s even being blamed for other pharma executives’ bad behavior, such as raising the price of the life-saving EpiPen. The first potential juror interviewed Monday, a young woman in her 30s, called Shkreli “an evil man.” Another woman said she knew he’d been labeled “the most hated man in America,” while a third woman declared, “I looked right at him and, in my head, I said ‘that’s a snake.”’ They were among at least a dozen people dismissed from jury service because of their strong opinions about Shkreli and at least three potential jurors blamed him for a spike in the price of the EpiPen. (Hurtado and Egkolfopoulou, 6/26)

Martin Shkreli got his first taste of Wall Street as an intern for a hedge fund firm started by CNBC personality Jim Cramer. After striking out on his own, he developed a reputation for aggressive tactics, including betting a company’s stock price would fall and then berating its executives on social media. His battles earned him a spot on Forbes list of “30 under 30” after, the magazine said, Shkreli torpedoed a health care industry merger and “antagonized” pharmaceutical giant Pfizer into removing its former chief executive from the company’s board of directors. Shkreli, now 34, is a “boy genius,” his attorney has said. (Merle, 6/27)

Danish pharmaceutical company Novo Nordisk A/S is betting that wider uptake of its products in China will offset price reductions required by the Chinese government. Chinese regulators will soon decide whether to include two of Novo Nordisk’s newer medications — Victoza, used to treat Type 2 diabetes, and NovoSeven, a hemophilia treatment — on the country’s reimbursement drug list. The state-funded program reimburses Chinese patients part or all of the drug’s price, depending on its classification. (Trentmann, 6/27)

Ahalf dozen U.S. senators want the U.S. Army to hold a public hearing to explore the controversy over the pricing of a Zika virus vaccine that Sanofi is developing with taxpayer dollars. In a letter sent on Monday to Acting U.S. Secretary of the Army Robert Speer, the lawmakers expressed concerns that a vaccine would not be “accessible and affordable” for many Americans, since the company may win an exclusive license to develop the technology and have “monopolistic” rights through 2036. (Silverman, 6/26)

The first ever EU antitrust probe into excessive drug pricing is taking the European pharmaceuticals industry into uncharted territory, unnerving some companies and lawyers worried about the reach of market intervention. It comes as drugmakers face global pressure over the high cost of prescription medicines, with particular anger focused on makers of older generic products who exploit limited competition to force through big price rises. (Chee and Hirschler, 6/26)

The festivities are over here at BIO 2017, but it’s been a busy week at the the drug industry’s big annual networking conference. It’s been telling, too, of what biotech leaders see as their industry’s biggest opportunities, priorities, and problems. Here are our takeaways from four days of talking and listening to executives here. (Robbins and Garde, 6/23)