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FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties

November 28, 2014 Comments off

FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties
Source: U.S. Food and Drug Administration

The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistentwith the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.

Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected. The tablet is difficult to crush, break or dissolve. It also forms a viscous hydrogel (thick gel) and cannot be easily prepared for injection. The FDA has determined that the physical and chemical properties of Hysingla ER are expected to make abuse by these routes difficult. However, abuse of Hysingla ER by these routes is still possible. It is important to note that taking too much Hysingla ER, whether by intentional abuse or by accident, can cause an overdose that may result in death.

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11 No-Fly Zones in the United States

November 26, 2014 Comments off

11 No-Fly Zones in the United States
Source: AllGov.com

For every sensible decision the government makes, there are others that cause plenty of head scratching.

Look at the number—and selections—of no-fly zones in place around the United States. Eleven of them discussed at the website Mental Floss represent a mix of locations, some of which make complete sense.

Planes flying over Washington, D.C., are limited to certain commercial and other pre-approved flights up to an altitude of 18,000 feet. These restrictions came after the 9/11 attacks in the run-up to the Iraq war and are aimed at protecting federal government installations.

The same logic can be applied to the Pantex nuclear facility outside Amarillo, Texas. The Cold War-era facility handles all kinds of nuclear warheads, so it requires special protection from above. Likewise, the Naval Submarine Base in Kings Bay, Georgia that serves as the home port of the U.S. Atlantic fleet of Trident nuclear subs has a no-fly zone above it.

Other government installations covered by overflight restrictions are the Kennedy Space Center and the famed Area 51 in Nevada, which has long been a classified government facility for, well, no one truly knows what.

The sky over Camp David is also off-limits to aircraft. Again, makes sense considering it is a popular getaway and meeting place for the president and special guests, including foreign leaders. Another presidential-related area that has been declared off limits to air traffic below 1,000 feet is the Bush family compound near Kennebunkport, Maine.

But then there’s restricted airspace over Disneyland and Disney World. The restrictions below 3,000 feet were slipped into a 2003 spending bill. Disney has fought off previous attempts to remove them because it doesn’t want banner planes flying over its parks.

Fleecing Uncle Sam; A growing number of corporations spend more on executive compensation than federal income taxes

November 26, 2014 Comments off

Fleecing Uncle Sam; A growing number of corporations spend more on executive compensation than federal income taxes
Source: Institute for Policy Studies

This report reveals stark indicators of the extent to which large corporations are avoiding their fair share of taxes.

Of America’s 30 largest corporations, seven (23 percent) paid their CEOs more than they paid in federal income taxes last year.

  • All seven of these firms were highly profitable, collectively reporting more than $74 billion in U.S. pre-tax profits. However, they received a combined total of $1.9 billion in refunds from the IRS.
  • The seven CEOs leading these tax-dodging corporations were paid $17.3 million on average in 2013. Boeing and Ford Motors both paid their CEOs more than $23 million last year while receiving large tax refunds.

Of America’s 100 highest-paid CEOs, 29 received more in pay last year than their company paid in federal income taxes—up from 25 out of the top 100 in our 2010 and 2011 surveys.

  • These 29 CEOs made $32 million on average last year. Their corporations reported $24 billion in U.S. pre-tax profits and yet, as a group, claimed $238 million in tax refunds.
  • Combined, the 29 companies operate 237 subsidiaries in tax havens. The company with the most subsidiaries in tax havens was Abbott Laboratories, with 79. The pharmaceutical firm’s CEO paycheck was $4 million larger than its IRS bill in 2013.

For corporations to reward one individual, no matter how talented, more than they are contributing to the cost of all the public services needed for business success reflects the deep flaws in our corporate tax system. Rather than more tax breaks, Congress should focus on addressing these deep flaws by cracking down on the use of tax havens, eliminating wasteful corporate subsidies, and closing loopholes that encourage excessive executive compensation.

The Internal Revenue Service Advisory Council (IRSAC) Releases 2014 Annual Report

November 25, 2014 Comments off

The Internal Revenue Service Advisory Council (IRSAC) Releases 2014 Annual Report
Source: Internal Revenue Service

The Internal Revenue Service Advisory Council held its annual public meeting today and released its annual report, which includes recommendations on a wide range of tax administration issues.

IRSAC is an advisory group to the entire agency. IRSAC’s primary purpose is to provide an organized public forum of relevant tax administration issues for the Commissioner, senior IRS executives and representatives of the public to discuss relevant tax issues.

IRSAC members convey the public’s perception of professional standards and best practices for tax professionals and IRS activities; offer constructive observations regarding current or proposed IRS policies, programs, and procedures; and suggest improvements to IRS operations.

Based on its findings and discussions, IRSAC made several recommendations on a broad range of issues and concerns including IRS funding, as well as topics identified by subgroups covering the Office of Professional Responsibility and Large Business and International, Small Business/Self-Employed and Wage and Investment operating divisions.

IRSAC is administered by the National Public Liaison Office. IRSAC draws its members from the tax professional community and members of academia.

U.S. Senate Permanent Subcommittee on Investigations — Subcommittee finds Wall Street commodities actions add risk to economy, businesses, consumers

November 25, 2014 Comments off

Subcommittee finds Wall Street commodities actions add risk to economy, businesses, consumers
Source: U.S. Senate Permanent Subcommittee on Investigations

Wall Street banks have become heavily involved with physical commodities markets, increasing risks to financial stability, industry, consumers and markets, a two-year investigation by the Senate Permanent Subcommittee on Investigations has found.

The investigation’s findings, contained in a 396-page bipartisan report, add important new details to the public debate about the breakdown of the traditional barrier between commercial activities and banking. Included are previously unknown details about activities by Morgan Stanley, JPMorgan Chase and Goldman Sachs, including Goldman Sachs’ controversial management of warehouses storing most of the warranted aluminum in the United States. The new details raise new questions about whether such activities harm businesses and consumers and allow for possible manipulation of the markets.

See also:
Wall Street Bank Involvement With Physical Commodities (Day One)
Wall Street Bank Involvement With Physical Commodities (Day Two)

New From the GAO

November 25, 2014 Comments off

New GAO Reports
Source: Government Accountability Office
1. Group Purchasing Organizations: Funding Structure Has Potential Implications for Medicare Costs. GAO-15-13, October 24.
http://www.gao.gov/products/GAO-15-13
Highlights – http://www.gao.gov/assets/670/666643.pdf

2. Medicare Program Integrity: CMS Pursues Many Practices to Address Prescription Drug Fraud, Waste, and Abuse. GAO-15-66, October 24.
http://www.gao.gov/products/GAO-15-66
Highlights – http://www.gao.gov/assets/670/666648.pdf

New From the GAO

November 24, 2014 Comments off

New GAO Reports
Source: Government Accountability Office
1. Group Purchasing Organizations: Funding Structure Has Potential Implications for Medicare Costs. GAO-15-13, October 24.
http://www.gao.gov/products/GAO-15-13
Highlights – http://www.gao.gov/assets/670/666643.pdf

2. Medicare Program Integrity: CMS Pursues Many Practices to Address Prescription Drug Fraud, Waste, and Abuse. GAO-15-66, October 24.
http://www.gao.gov/products/GAO-15-66
Highlights – http://www.gao.gov/assets/670/666648.pdf

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