After New Year’s, expect more drug pricing fireworks in 2019

March 28, 2019 Already since the midterms, Democratic lawmakers have floated a bill directing the Department of Health and Human Services (DHHS) Secretary to break patents and allow generic competition when U.S. branded drug prices come in above their median price in Canada, the U.K., Germany, France and Japan. Additionally, Sen. Elizabeth Warren and Rep. … Read more

‘Bad drug’ lawsuit ads hurt doc-patient relationships and need regulation, says industry coalition

March 26, 2019 Sound familiar?  Trial lawyer “bad drug” ads have proliferated for years; however, one newly formed organization is pushing back.  The Partnership to Protect Patient Health is a coalition of national physician and patient advocacy groups that believe the lawsuit advertising needs to be addressed as a healthcare issue that can disrupt physician-patient relationships. … Read more

The Apple Watch’s ECG features are live

March 21, 2019 The watch can now also track a person’s pulse in the background and send the wearer a notification if it detects what could be atrial fibrillation, the most common form of irregular heart rhythm.  The notification feature will also work with heartbeat sensors on earlier versions of the Apple Watch, alerting the … Read more

National Cancer Institute’s Sharpless to Serve as Acting FDA Commissioner

March 19, 2019 Sharpless, who has served as NCI director since October 2017, previously served as Director of the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center, a position he held since January 2014.  He earned his medical degree from the UNC School of Medicine, completed his internal medicine residency at the Massachusetts General … Read more

Trump’s budget plan puts squeeze on NIH, boosts FDA

March 14, 2019 The plan is allocating $35.4 billion for the NIH — estimated to be somewhere between $4.5 and $6 billion less than in the current financial year — and is accompanied by other cuts including a $1 billion reduction for the National Science Foundation (NSF).  Among the biggest losers within the NIH are … Read more

FDA Chief Scott Gottlieb steps down, leaving pet projects behind

March 07, 2019 Gottlieb won Senate confirmation as FDA Commissioner back in May 2017, an uncertain time for the drug industry.  During the selection process, his name had been favored by a majority of biopharma executives polled by an analyst.  At the time, one anonymous executive said he is the “least likely to rail for the … Read more

Gottlieb Testifies on Status of FDA Operations After Government Shutdown

March 05, 2019 Members of the Subcommittee on Agriculture, Rural Development, FDA and related agencies questioned Gottlieb on the status of the Agency’s operations, particularly regarding efforts to mitigate the impact of the government shutdown. T hey pointed to FDA’s inspectional work of medical product manufacturing facilities and reserve of industry user fees as areas … Read more

Careful, reps: Doctors are watching, FDA promo police’s latest rebuke shows

March 01, 2019 What’s different about the FDA’s latest untitled letter?  It involves words spoken by a sales rep.  It marks only the 14th time a Warning or Untitled Letter has involved an oral statement, said Mark Senak, a Public Relations professional and Eye on FDA blogger.  The last time a sales rep was involved … Read more