Democrats Announce Three-Pronged Plan To Tackle High Drug Prices

Politico: Democrats' 'Better Deal' Would Penalize Drug Price Hikes
Democrats are going straight at one of the top concerns of voters, using the rising cost of drugs to strike a more populist tone and counter President Donald Trump, who campaigned hard against the power of the drug industry, but took a friendlier stance after taking office. Congressional Democrats [on Monday] laid out a three-pronged approach to lower the cost of prescription drugs in the United States that aims to stop large price increases and give the federal government more power to influence what Medicare pays for medicines. (Karlin-Smith, 7/24)

CNBC: Democrats Take Aim At Big Business, Drug Prices, In Economic Campaign
Democrats are proposing an independent agency to tackle the high cost of prescription drugs. The director would be appointed by the president and confirmed by the Senate, charged with investigating drug manufacturers and able to slap fines on companies with exorbitant rate hikes. Pharmaceutical companies would also be required to notify the government of substantial price increases. (Mui, 7/23)

Stat: How Pricey Is Your Drug? These 10 Sold The Most In The U.S. Last Year
Awhopping $450 billion was spent in the United States on prescription drugs last year. Topping the list, perhaps unsurprisingly, are medications whose patents were still in force or had recently expired. When a patent expires, generic versions — or biosimilar versions of biologic drugs — can become available, driving down costs that in turn make them accessible to more patients. (Blau, 7/25)

Stat: FDA May Publicly Shame Drug Makers For Thwarting Generic Rivals
The idea is to break a logjam caused by an FDA program that is designed to boost safety. Typically such a program, known as a Risk Evaluation and Mitigation Strategy, requires drug makers to develop a plan to educate doctors and monitor distribution. But generic companies claim they have been denied samples of brand-name drugs needed to conduct product testing in order to win FDA approval. Brand-name companies argue that REMS programs do not permit such sharing. (Silverman, 7/19)

FierceHealthcare: Democrats Revive Calls For Medicare To Negotiate Drug Prices
As part of their newly unveiled “Better Deal” agenda, congressional Democrats are pledging to tackle one of healthcare’s thorniest issues—the high cost of prescription drugs. “Right now, there’s nothing to stop vulture capitalists from egregiously raising the price of life-saving drugs without any justification,” Senate Minority Leader Chuck Schumer, D-N.Y., said during a press conference Monday. (Small, 7/25)

Stat: Ohio Places Drug Pricing Measure On Its November Ballot
In a blow to the pharmaceutical industry, Ohio state officials have approved a controversial initiative designed to lower drug prices for the November ballot. Known as the Ohio Drug Price Relief Act, the ballot measure would require state agencies to pay no more for medicines than the Department of Veterans Affairs. The agency currently gets a 24 percent federally mandated discount off average manufacturer prices. (Silverman, 7/21)

The Blade: Television Ads Clash Over Ohio Drug Price Relief Act
The conflicting claims in the prescription drug issue that will be on the Ohio ballot in November are enough to cause a headache. Or even something requiring a prescription. The most recent flurry of ads last week on broadcast television attacked the previous flurry of TV ads, each accusing the other of deceptive tactics to manipulate Ohio voters. What to believe? (Troy, 7/24)

The Associated Press: ‘Pharma Bro’ Won’t Stop Talking, Except To Jury In Trial
“Pharma Bro” Martin Shkreli has kept up his trademark trolling on social media during his securities fraud trial — calling the case “bogus” — but the jury won’t hear him defend himself in court. The government’s last witness testified on Tuesday, a day after a lawyer for the former biotech CEO told the court that his client had chosen not to take the witness stand. Closing arguments are expected later this week. (Hays, 7/26)

Stat: Proposed Rule To Bolster Safety Data On Generic Drug Labels May Be Dead
Once again, a controversial rule for updating generic drug labeling is being postponed, but this time, its chances of being implemented appear slimmer than ever, according to consumer advocates. The rule was proposed four years ago by the Food and Drug Administration in an effort to bolster patient safety. Specifically, the rule would allow generic drug makers to independently update safety warnings, something only brand-name drug makers can currently do before receiving FDA permission. (Silverman, 7/24)

Marketplace: Drug Prices: How Generics Changed The Game
For a time, high drug prices made headlines, and it looked like the issue could be tackled by the Trump administration. But as we all know, efforts to repeal Obamacare have consumed Republicans much of this year. The drug problem hasn’t gone away; it’s just lingering in the background. Even the cost of some generic drugs are rising. (Gornstein, 7/25)

CQ Roll Call: FDA Notice Buys Senate More Time On User Fee Bill
The Food and Drug Administration will delay issuing furlough notices to employees whose salaries depend on congressional action renewing the agency’s fee-collection authority, FDA Commissioner Scott Gottlieb announced Monday in an email obtained by CQ. Gottlieb’s announcement effectively gives Congress until Sept. 30 to pass a bill that would provide the agency with about $1.4 billion in annual funding through fiscal 2022 from the prescription drug and medical device industries. That money mostly goes to the salaries of employees who review medical product applications. Lawmakers previously believed the agency would begin issuing furlough notices 60 days before funding lapsed on Sept. 30, and were aiming to finish work on the bill by late July. (Siddons, 7/24)

Bloomberg: Trump's FDA Commissioner On Drug Prices, Regulations, Science
U.S. Food and Drug Administration Commissioner Scott Gottlieb spoke with Bloomberg News about drug pricing, new medicine and regulations. This transcript of the interview has been edited for clarity and length. (Edney and Mattingly, 7/24)

Stat: How Do You Measure Value In A Drug — Or Anything Else In Medicine?
At a swanky hotel in the Theatre District, about a dozen health policy experts and drug development academics gathered Wednesday to talk drug pricing. Speakers on the Manhattan Institute-curated panel see a future where the amount of money people pay for pharmaceuticals has something to do with how much “value” they provide — but seemed to have more questions than answers about what that actually means. (Swetlitz, 7/19)

The New York Times: Celgene To Pay $280 Million To Settle Fraud Suit Over Cancer Drugs
The pharmaceutical company Celgene has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid and Revlimid for unapproved uses, the company said on Tuesday. Under the terms of the settlement, which resulted from a lawsuit filed by a whistle-blower — a former sales representative at Celgene — the company will pay $259.3 million to the United States and $20.7 million to 28 states and the District of Columbia. (Thomas, 7/25)

Stat: A New HIV Drug's Strong Results Give A Big Boost To Gilead Sciences
An experimental HIV pill from Gilead Sciences suppressed the virus in newly diagnosed patients at a rate statistically equivalent to that of a similar, rival drug from GlaxoSmithKline, according to results from a late-stage clinical trial presented Monday. The positive data supporting Gilead’s new HIV pill, a second-generation integrase inhibitor called bictegravir, are vitally important to the Foster City, Calif.-based biotech company. Sales of Gilead’s hepatitis C drugs are falling and its oncology pipeline has largely disappointed, so the company is once again reliant on its HIV business for the majority of its profits. (Feuerstein, 7/24)

Stat: AbbVie Must Pay $150 Million For Misleading AndroGel Marketing
In a split decision, a federal jury in Chicago ordered AbbVie to pay $150 million in punitive damages for fraudulently misrepresenting the risks of its AndroGel testosterone replacement drug. But at the same time, the jury decided the drug maker was not liable for a heart attack that the plaintiff, Jesse Mitchell, suffered after taking the medication. The trial was the first in an estimated 6,000 lawsuits that the drug maker faces over its controversial marketing, which warned that low testosterone can interfere with sex drive, moods, and energy levels. However, the increased usage was accompanied by dueling medical studies — and subsequent debate — over the extent to which AndroGel and other such drugs could increase cardiovascular risks. (Silverman, 7/24)

Boston Globe: Vertex Reports Strong Findings From Cystic Fibrosis Drug Trials
Vertex Pharmaceuticals Inc. on Tuesday released clinical findings showing its new approach to combating cystic fibrosis substantially improved lung function in patients, lifting hopes for a treatment that could be used by about 68,000 people worldwide — including 24,000 who don’t respond to any existing medicines. The results prompted Boston-based Vertex to say it plans to launch one or two late-stage clinical trials of the biotech’s three-drug combination in the first half of next year. (Weisman, 7/18)

Stat: Merck: Keytruda Trial Comes Up Short In Head And Neck Cancer, But FDA Approval Stays
Merck’s checkpoint inhibitor Keytruda doesn’t help patients with advanced head and neck cancer live longer, but the failed phase 3 clinical trial, announced Monday night, won’t compel the FDA to rescind the drug’s conditional approval, the company said. And with that, the pile of evidence pointing towards FDA’s extreme flexibility when it comes to easy drug approvals grows even larger. (Feuerstein, 7/24)