Senators Ask Leadership To Reverse Trump’s Decision To Slash Funding For Drug Discount Program
The group of lawmakers looking to save the 340B program is made up of both Democrats and Republicans. In other pharmaceutical news: an analysis shows that many drugmakers are behind on required post-marketing studies; the Supreme Court shows interest in taking up the product liability issue; Sage announces positive results from its depression drug trial; and more.
The Hill:
Bipartisan Group Of Senators Seek To Block Trump Cuts To Drug Discount Program
Six senators, including three Republicans, are asking GOP leadership to block a Trump administration rule that slashes funding for a federal drug discount program. The program, called 340B, requires drug companies give discounts to health-care organizations that serve high volumes of low-income . (Hellmann, 12/7)
Stat:
Drug Makers Continue To Owe FDA Numerous Clinical Trials
Under various circumstances, the Food and Drug Administration may require a drug maker to run a post-marketing study, but a large percentage of these studies are still pending, according to the latest agency analysis. As of the end of fiscal year 2016, 86 percent of required studies were still pending, which meant they were not yet under way. An average of 261 post-marketing requirements were made each year since fiscal year 2010, and most that were established several years ago were since fulfilled or released. Of the required studies pending as of September 30, 2016, 83 percent were created within the past three years, according to the FDA analysis. (Silverman, 12/7)
Stat:
Merck Urges The Supreme Court To Revamp Product Liability For Pharma
In a move that should hearten the pharmaceutical industry, the U.S. Supreme Court appears interested in revisiting a contentious legal issue which has the potential to affect lawsuits filed by consumers. Earlier this week, the court asked the U.S. solicitor general to offer an opinion on a case involving Merck (MRK), which is hoping to dispense hundreds of lawsuits filed more than seven years ago by women who claim they suffered bone fractures after taking Fosamax, a drug used to combat osteoporosis. (Silverman, 12/7)
Stat:
Sage's New Depression Drug Hits Mark In Clinical Trial, Though Effects Fade Over Time
Fresh off a big clinical trial victory in postpartum depression, Sage Therapeutics (SAGE) announced yet more good news Thursday: Positive results from a mid-stage clinical trial for a pill to treat people with major depressive disorder. The drug appears to work quickly, though its effects diminish over time. If Thursday’s results are confirmed in later phase 3 clinical trials, the Sage pill, known as SAGE-217, could become one of the first medicines in years with a new mechanism of action to be approved for the treatment of depression. (Feuerstein, 12/7)
Kaiser Health News:
Cities, Counties And Schools Sidestep FDA Canadian Drug Crackdown, Saving Millions
Schenectady County, N.Y., is on track to pay 20 percent less on prescription drugs for its employees this year than in 2003. Flagler County, Fla., expects to save nearly $200,000 in 2017 on brand-name medicines for its 800 workers, its total drug costs having fallen by 10 percent since last year. Kokomo, Ind., has found a way to save so much money buying drugs that it offers employees a 90-day supply of dozens of popular brand-name medicines for free. (Galewitz, 12/8)
Stat:
Isaly Steps Down From Hedge Fund Giant OrbiMed After Harassment Claims
Sam Isaly, founder of biotech’s largest and most powerful biotech hedge fund, is stepping down from his leadership role at OrbiMed Advisors following a barrage of sexual harassment allegations published by STAT. OrbiMed put out a statement on Thursday night asserting that Isaly is retiring “pursuant to years-long succession planning discussions.” However as recently as Monday, when STAT interviewed Isaly about the allegations against him, he said there was “no planned date” for his retirement. (Garde, 12/7)
