News & Information
Adulterated Diet Supplements: Should FDA Do More?
Written by Editor   
Tuesday, October 16, 2018 01:29 PM

Even after FDA warnings are issued, many adulterated dietary supplements remain available for purchase, according to a quality-improvement study.  Of dietary supplements available for sale in the U.S. from 2007 to 2016, the FDA identified 776 that were adulterated with active pharmaceuticals.

Calling this an “important public health concern," these researchers said that nearly 68% of these supplements had new unapproved ingredients that were reported in the second or third warning by the FDA, "consistent with the assumption that the FDA found the product to be adulterated more than once."

The products identified in the study appeared in the agency's Tainted Supplements database, and most often were marketed for sexual enhancement (46%), weight loss (41%), or muscle building (12%).

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CMS to Require Drugmakers to List Prices in Ads
Written by Editor   
Tuesday, October 16, 2018 01:18 PM

The CMS plans to require prescription drug manufacturers to their list prices in direct-to-consumer television advertisements.  Under the proposed rule, drugmakers will have to post the price of a typical course of treatment for acute medications like antibiotics or for a 30-day supply of medications for chronic conditions. Consumer ads will have to have a readable, text statement at the end to comply with the mandate.

"This historic proposal is an important way to create new incentives for drug companies to start lowering their list prices, rather than raising them," HHS Secretary Alex Azar said in a statement. "President Trump's drug-pricing blueprint called for HHS to consider how to accomplish this goal, and now we are following through on this measure to better inform patients, help them lower their drug costs, and reduce unreasonable spending in Medicare and Medicaid."

Drugs with list prices under $35 per month will be exempt from the requirement. The CMS requested comments on whether the regulation should apply to radio, web, print or social networking advertising as well.

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Anthem to pay $16M in record data breach settlement
Written by Editor   
Tuesday, October 16, 2018 12:45 PM

Anthem has agreed to pay the federal government $16 million in a settlement over its 2015 data breach that hit nearly 79 million people. The agreement is by far the largest settlement reached by HHS' Office for Civil Rights for a Health Insurance Portability and Accountability Act (HIPAA) breach. Hackers stole the names, birth dates, Social Security numbers, home addresses and other personal information in the 2015 cyberattack.

The largest health data breach in U.S. history fully merits the largest HIPAA settlement in history.  ”Unfortunately, Anthem failed to implement appropriate measures for detecting hackers who had gained access to their system to harvest passwords and steal people's private information."

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$1B Telemedicine Fraud Scheme Alleged
Written by Editor   
Tuesday, October 16, 2018 12:35 PM

Telemedicine is a growing area of medical fraud concern.  Federal prosecutors have announced that seven companies and four men are facing charges, accused of roles in a $1 billion telemedicine fraud scheme that deceived tens of thousands of patients and more than 100 doctors. 

Six Florida companies, a Houston firm and four Florida men are named in a 32-count indictment charging them with conspiracy to commit health care fraud, introducing misbranded drugs into interstate commerce and mail fraud.

According to prosecutors, this group created an “elaborate” scheme in which telemedicine firm HealthRight LLC fraudulently solicited insurance information and prescriptions from customers nationwide for pain creams and similar products.

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Over 30 Retractions of Cardiac Stem Cell Research
Written by Editor   
Tuesday, October 16, 2018 12:24 PM

Harvard Medical School and Brigham and Women’s Hospital have recommended that 31 papers from a former lab director who studied cardiac stem cells be retracted from medical journals.  The data “included falsified and/or fabricated data,” according to a statement to Retraction Watch and STAT from the two institutions.

This doctor “practically invented the field of cardiac stem cell therapy when he first reported that cardiac cells were capable of regeneration,” it has been reported.  He  published at least 55 papers that listed Harvard as an affiliation. He has received several commendations, including a research achievement award from the American Heart Association, which in 2004 also named him a “distinguished scientist.”

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