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Latest Morning Briefing Stories

Generic Drugmakers Get Year-End Gift As FDA Backs Off Product-Liability Rule Proposal

KHN Morning Briefing

At issue was proposed regulation that would have allowed generic drug companies to update their product labeling when new information about a medicine’s safety is revealed, a move that could open drugmakers up to lawsuits. Commissioner Scott Gottlieb and the FDA’s drug-center director Janet Woodcock said in a statement, “We heard from manufacturers that they believed this change would have imposed on them significant new burdens and liabilities.”

Gottlieb’s Idea To Help Lower Insulin Prices By Encouraging Competition Doesn’t Impress Industry Experts

KHN Morning Briefing

“The starting point is very different for insulin,” said Andrew Mulcahy, a policy researcher. “Will more competitors help bring down prices further? Yes, but it’s starting off from a place where there is already some of that price competition.” Meanwhile, lawmakers in Minnesota, where some diabetics say they are rationing insulin, consider price controls due to the high costs.

Grocery Store Launches Membership Program Where Patients Pay Annual Fee To Get Discounts On Prescription Drugs

KHN Morning Briefing

The Kroger Rx Savings Club will be available in more than 2,000 pharmacies. The initiative comes as experts and patients are beginning to pay more attention to the savings that can sometimes accrue by paying cash for a medication instead of a high copay. In other pharmaceutical news: drug prices in television ads; insider trading; off-label use; and direct reimbursements; and more.

For Those Who Have Had Dramatic Overdose Videos And Photos Aired To Public, Life Will Never Be The Same

KHN Morning Briefing

One trend that’s emerged in the opioid epidemic is both the public and police departments releasing footage or photos of people who are experiencing some of the bleakest moments in their lives. The views on such videos can total in the millions, and some argue it’s beneficial, but for those in the videos it can change their lives forever–not necessarily for the better. Meanwhile, experts wonder if fentanyl could become a weapon of mass destruction to be used against the United States, and the maker of an anti-overdose drug overs a generic of a fraction of the price.

How An Antitrust Lawsuit Exploded Into A Massive Investigation Of Generic Drug Companies’ Alleged Price-Fixing

KHN Morning Briefing

The unfolding case is rattling an industry that has been portrayed as a savior to the high drug pricing problem. “This is most likely the largest cartel in the history of the United States,” said Joseph Nielsen, an assistant attorney general and antitrust investigator in Connecticut who has been a leader in the probe. He cited the volume of companies and drugs involved in the schemes. In other pharmaceutical news: shingles vaccine shortage, overcharging Medicaid for drugs, and a new CEO at Gilead.

Small Drug Companies Closely Watching Supreme Court Case On Patents

KHN Morning Briefing

A Swiss drugmaker is challenging a 2011 change to the law that no longer allows a company to patent an invention if it was for sale for more than a year before filing a patent application. Meanwhile, Congress also plans to focus on the issue of pharmaceutical patents and lawmakers continue to question the industry’s pricing decisions. And as Capitol Hill gears up for potential action on drug costs, there may be some lessons to be learned from China.

Drugmaker Actelion Agrees To Pay $360M To Settle Kickback Investigation

KHN Morning Briefing

The Justice Department alleged that Actelion Pharmaceuticals violated federal law by using a foundation fund to funnel kickback payments aimed at inducing patients to buy its drugs. Actelion was bought by Johnson & Johnson in 2017, after the alleged actions took place, and admits no wrongdoing as part of the settlement.

Brewing Battle Over Fetal Tissue Research Could Undermine Testing Of HIV Treatments

KHN Morning Briefing

Over the past few months, the Trump administration has been quietly auditing all federal funding involving fetal tissue research. The University of California at San Francisco’s research laboratory, which has been instrumental in testing virtually all HIV therapies subsequently approved by the FDA since the 1990s, has been sucked into the controversy.

Powerful Democrat, Republican Find Common Ground With Bill To Force Drug Companies To Play By Medicaid’s Rules

KHN Morning Briefing

Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) will be the top Republican and Democrat on the influential Senate Finance Committee next year. Their bipartisan bill would give HHS more power to recoup the full amount lost if companies misclassify their drugs under the Medicaid program. Experts watching Congress have predicted that drug prices might be a problem where the parties will work together.

Justice Department Wants Whistleblower Case Against Gilead To Be Tossed By Supreme Court

KHN Morning Briefing

The long-running suit involves allegations that Gilead misled regulators about contaminated ingredients used in various HIV medicines and falsified data to win marketing approval for the drugs. In its brief, the Justice Department argued the case may burden the FDA, but otherwise did not explain how it would not be in the public’s interest for the Supreme Court were to take up the case. Other pharmaceutical news looks at gift giving and gene therapy.

‘It’s In Many Ways All Theater’: China Vows To Stem Flood Of Fentanyl Into U.S., But It Promised That Under Obama Too

KHN Morning Briefing

Although the Trump administration is touting the promises, experts say there’s nothing new to get excited about. “There are economic incentives for the Chinese to let opioid production flourish and fewer incentives to restrict their economy to cooperate with foreign law enforcement. We will have to wait and see how much the Chinese government cracks down on fentanyl producers,” said Jeffrey Higgins, a retired special supervisory agent with the DEA.