Capsule: Drug Ads, Beefing Up Privacy, Ditching Regulations

From Pharma & Life Sciences News on Bloomberg Law

October 19, 2018

By Jacquie Lee

Welcome to Capsule—your weekly dose of health-care news, where we give you a recap of this week’s highs and lows for key players in the health-care industry. You can expect us every Friday morning as a bookend for your week.

This week has been steeped in international controversy as authorities continue to unravel how journalist Jamal Khashoggi died. He was last seen entering a Saudi consulate in Istanbul Oct. 2. The story is pretty chilling, and the latest from Bloomberg News is here. Let’s catch you up on any health-care news you may have missed in the meantime because it’s been a busy week.

Here’s who was left smiling this week:

First Amendment Lawyers
  • The stage is set for a legal clash of the Titans between the federal government and the country’s biggest drug group. The most influential names in the drug industry promised Oct. 15 to use their TV ads to direct consumers to drug pricing information. Alex Azar, head of the HHS, said it wasn’t good enough.
  • That same day, the federal Medicare agency proposed a rule to force certain drugmakers to put the list price of their products directly on their ads, Jeannie Baumann writes. Drugmakers are pushing back, saying the list price isn’t what most patients pay and it’s a useless and deceptive number to include in advertisements.
  • First Amendment lawyers will have plenty of work and potential billable hours the next few weeks as they answer questions on whether this oversteps constitutional bounds. A few lawyers tell Dana Elfin they think the government may be overstepping its authority this time.
  • PhRMA—the biggest drug lobbying group in the country—has insinuated it will take the issue to court. But no one can sue over a rule until it’s been finalized, meaning there’s still time for this issue to stew.
Privacy Enforcement
  • Anthem’s $16 million data-breach settlement may signal that the federal government is about to pick up the pace on privacy and security enforcement, James Swann reports. The settlement is the largest one negotiated by the HHS Office for Civil Rights and comes after a 2015 data breach impacting 79 million people.
  • The White House is also considering a rule that would give a percentage of penalties or settlements paid by health-care organizations responsible for data breaches to those who had their records compromised, Alex Ruoff writes. It could prompt hospitals and doctor’s offices to spend more money beefing up their security systems.
  • The changes are coming amidst mounting concerns over the security of wearable medical devices, like the Apple Watch, which have unique sets of security concerns, according to Swann.
Democrats’ PR Push
  • Democrats are making health-care reform a core principle of their campaign platforms this year—and this story from Alex Ruoff and Madi Alexander shows they’re doing a pretty good job getting their message out there.
  • Democrats have run almost three times as many ads mentioning health care as Republicans have this year. Only 28 percent of pro-Republican ads that ran this year focused on health care.
  • This reverses the trend from previous years, where Republicans were the ones talking about health-care coverage, primarily the Affordable Care Act. Democrats are also benefiting from a controversial lawsuit to undo the ACA’s protection of insurance for pre-existing health conditions. Republican leader Mitch McConnell (Ky.) is defending the case, even though it’s become a problem for Republican candidates, Bloomberg News’ Steven Dennis and Sahil Kapur report.

This week was not as kind to others. Here’s whose Thursday ended on a less positive note:

Regulations
  • The day the season’s regulatory agenda comes out is almost like a festival for policy wonks. So I’m sure regulation-lovers were a little disappointed if they noticed almost 20 of the rules mapped out in the Health and Human Service’s fall 2018 agenda were meant to scrap existing rules.
  • Part of President Trump’s campaign platform was to do away with burdensome rules. He vowed to ditch two existing regulations for every new rule he put in place.
  • One noticeable rule that’s been withdrawn would have required clinical study sponsors to immediately inform the FDA if they suspected data was being falsified in a study, Jeannie Baumann reports. The agency says the rule “is no longer needed given other existing requirements around the integrity of clinical trial data,” an FDA spokesperson told Baumann.
Four Guys in Florida (and Texas)
  • Four people and the seven pharmacies in Florida and Texas they operated were caught defrauding private insurance companies of nearly $1 billion through a fraudulent telemedicine scheme, Matt Phifer writes.
  • The Department of Justice says the plan revolved around huge markups of invalidly prescribed drugs. The indictments show the Justice Department is serious about cracking down on individuals—in addition to corporations—involved in health-care fraud, according to Phifer.
  • Allegedly the plan took place between June 2015 and April 2018. The four fraudsters could face up to a combined 33 years in prison each for their involvement in the conspiracy as well as fines of up to $250,000.
Abortion Law
  • Indiana is asking the U.S. Supreme Court to review a case that could lead to a substantial rollback of abortion law, Mary Anne Pazanowski reports.
  • The case surrounds a court decision about whether a woman can selectively terminate a fetus based on sex, race, or disability.
  • This may be the most consequential abortion case to come before the Supreme Court this term, Pazanowski writes. It directly challenges the concept that a woman may terminate a fetus before it is able to survive outside the womb, regardless of her reason for doing so.

Thanks for joining us this week and have a great weekend. I’m all ears when it comes to your two cents, tips, critiques, or coordinating exclusive interviews. Send them my way at jlee1@bloomberglaw.com.


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