Health Care

Comments to FDA on Labeling for Biosimilar Products

May 31, 2016  

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852.  

Re: Docket No. FDA-2016-D-0643
“Labeling for Biosimilar Products; Draft Guidance for Industry”  

Background

VA Sec. McDonald Is Living in a Fantasy Land

For Immediate Release Contact: Curtis Kalin 202-467-5318
May 23, 2016  

CAGW Outraged by HHS OIG’s Latest Improper Payment Review

Citizens Against Government Waste (CAGW) was outraged, if not surprised, at the report from the Department of Health and Human Services (HHS) Office of Inspector General (OIG) showing the ongoing failure of HHS executives to accurately report and prevent improper payments.  With the government-wide improper payment total at a staggering $137 billion in fiscal year (FY) 2015 (and rising), the OIG outlines some of the steps that agency has taken to stem the tide of red ink, but finds significant operational failures, in both its reporting of improper payments and implementing corrective action plans. 

CAGW Releases May 2016 WasteWatcher

For Immediate Release Contact: Curtis Kalin 202-467-5318
May 12, 2016  

(Washington, D.C.) – Today Citizens Against Government Waste (CAGW) released its May WasteWatcher, a monthly dispatch to members of the news media, highlighting some of the most prominent fiscal issues affecting American taxpayers.  The stories from its May edition of WasteWatcher are listed in part as follows:

State Tobacco Settlement Funds Go Up In Smoke

In 1998, 46 states and five U.S. territories signed onto the Master Settlement Agreement (MSA) in order to recover taxpayer dollars lost to the treatment of tobacco-related health issues, which would then be used to fund anti-smoking campaigns and public health programs.  As part of the settlement, the states and territories will receive an estimated total of $246 billion over the first 25 years.

A New Cause du Jour: Beating Up “Big Pharma”

Beating up pharmaceutical companies is the new “cause du jour.”  Even though pharmaceuticals are only 10 percent of all healthcare costs, they tend to make easy targets because it is difficult to understand why such a small pill should cost so much money.

Got Some Splainin To Do

Yesterday, May 10, 2016, the House and Energy Commerce Committee released a report, which demonstrates the Centers for Medicare and Medicaid Services (CMS) Acting Administrator Andrew Slavitt provided false testimony in a House Energy and Commerce Subcommittee on Oversight and Investigations hearing, “An Overdue Checkup Part II: Examining the ACA's [Affordable Care Act] State Insurance Marketplaces.”  The hearing was held December 8, 2015.

UnitedHealthcare Cries Uncle

On Tuesday, April 19, UnitedHealthcare CEO Stephen Hemsley announced that the company would be pulling out of most of the Affordable Care Act’s (ACA), or Obamacare, marketplace exchanges.  This announcement did not come as a surprise.  On November 19, 2015, The Hill reported, “At a shareholder meeting Thursday, UnitedHealthcare cast doubt on its ability to carry plans on the healthcare law’s exchanges beyond 2016, offering a more grim financial outlook than it had previously expected.  ‘In recent weeks, growth expectations for individual exchange participation have tempered industrywide,’ said Stephen Hemsley, the company's CEO.  ‘Co-operatives have failed, and market data has signaled higher risks and more difficulties while our own claims experience has deteriorated, so we are taking this proactive step.’"

CAGW Releases April 2016 WasteWatcher

For Immediate Release Contact: Curtis Kalin 202-467-5318
April 19, 2016  

(Washington, D.C.) – Today Citizens Against Government Waste (CAGW) released its April WasteWatcher, a monthly dispatch to members of the news media, highlighting some of the most prominent fiscal issues affecting American taxpayers.  The stories from its April edition of WasteWatcher are listed in part as follows:

Lawyering Up Over Labels

On November 13, 2013, the Food and Drug Administration (FDA) released a proposed rule that would allow generic pharmaceutical firms to provide new safety information and update a drug’s label without first getting FDA approval, even though doing so would make it different from the reference drug’s (the original brand-name) label.  If the proposed rule should go in effect, it is conceivable that several versions of labels for the same medication could exist, creating uncertainty for physicians, pharmacists, and patients.

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CAGW Names Rep. Elijah Cummings November 2017 Porker of the Month

Rep. Cummings is CAGW's November Porker of the Month for attempting to place price controls on prescription drugs.