Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Lags On Rule To Strengthen Protections For Patients Using Generics
Los Angeles Times: New Warning Rule For Users Of Generic Drugs Is Left In Limbo
Five years after the Supreme Court blocked most personal-injury lawsuits against makers of generic drugs, a rule designed to strengthen patient protections [has] stalled, leaving what consumer groups warn is a safety gap for millions of users. After several delays, the Food and Drug Administration said last year it would ... issue a new rule by the end of this month to require generic drug makers to update their warning labels in response to newly revealed risks. But the agency quietly said recently it had put off a final decision until early next year. (Savage, 7/21)
Stat: How Tinkering With A Mellow Messenger In The Brain Could Yield New Drugs
It’s a well-known messenger in the brain: a neurotransmitter dubbed GABA that mellows us out. Drug developers have been tinkering with it for decades, and they’ve scored some big hits, notably Xanax and Valium. Now, they’re reaching for even bigger targets. A flurry of startups are working to target the GABA pathway with more precision than ever before, hoping to come up with medications that can treat a range of neurological disorders and mental illnesses. (Keshavan, 7/22)
And in other pharmaceutical news —
Stat: Pfizer Spars With The Taxman Again, Seeks $8 Million In Overdue Interest
If nothing else, Pfizer is extremely diligent about anything involving taxes. The big drug maker, which raised a national ruckus by pursuing acquisitions designed to lower its tax rate, has engaged in another showdown of sorts with the US Department of Treasury. The latest dispute however, involves decidedly lower stakes — nearly $8.3 million in interest that Pfizer claims it’s owed on a $500 million overpayment that was noted on its 2008 tax return. (Silverman, 7/21)
The Wall Street Journal: Amgen And Allergan Study Finds Biosimilar Comparable To Herceptin
Amgen Inc. and Allergan PLC on Thursday said a late-stage trial of their treatment being developed as a biosimilar to Roche Holding AG’s breast cancer drug Herceptin met its primary endpoint, another step in bringing cheaper versions of some of biotechnology’s best-known cancer drugs to the market. The study, evaluating the effectiveness and safety of ABP 980 compared with trastuzumab, the clinical name for Herceptin—a multibillion-dollar medicine that in the past two decades has transformed treatment for about 25% of breast-cancer patients—ruled out inferiority but couldn't rule out superiority. (Steele, 7/21)
