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November 3, 2011
by Julie Baker
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Drug Shortages and the FDA

The news is filled with horror stories of drug shortages: cancer patients waiting for chemo medication; important drug trials delayed; death rates increasing from treatable diseases; price gouging; and more.  The FDA has been under fire for their failure to respond to the increasing prevalence of drug shortages. The White House responded by calling on the agency to develop a plan of action to prevent these shortages and the astronomical markups for drugs in demand. The FDA today released its report, A Review of FDA’s Approach to Medical Product Shortages.

Here is a summary of the problem as outlined in the 44-page document:

  • The FDA does not have legal authority to require companies to continue manufacturing medications that are in shortage. However, manufacturers of certain drugs are required to provide advance notification to FDA of production discontinuance.
  • The FDA helped to prevent 38 drug shortages in 2010 and 99 to date in 2011. Despite this fact, the number of drug shortages annually tripled from 61 in 2005 to 178 in 2010.
  • Of the 127 studied drug shortages in 2010‐11, sterile injectables accounted for the majority (80%). The major therapeutic classes of drugs in shortage included oncology drugs (28%), antibiotics (13%), and electrolyte/nutrition drugs (11%).
  • The leading primary reasons for the shortages reported to FDA were problems at the manufacturing facility (43%), delays in manufacturing or shipping (15%), and active pharmaceutical ingredient shortages (10%).
  • Manufacturing quality problems that have resulted in shortages can be serious, including findings of glass shards, metal filings, and fungal or other contamination in products meant for injection into patients.

The FDA’s proposed recommendations include:

  • Expedite review of new manufacturing sites, new suppliers, specification changes, and regulatory submissions.
  • Exercise regulatory flexibility and discretion.
  • Continue reaching out to other firms to increase production.
  • Work with manufacturers to identify means to mitigate the dangers of products with quality issues.

The complete report is available at the link provided above. What do you think? Are you satisfied with the FDA report? Are there other steps the FDA or the pharmaceutical industry could take to mitigate this problem?

November 2, 2011
by Julie Baker
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The Sensible Accounting to Value Energy (SAVE) Act

A bill now making its way through Congress, the Sensible Accounting to Value Energy (SAVE) Act, is garnering a groundswell of support from those within the real estate appraisal industry.

Under the SAVE Act, federal loan agencies would assess a borrower’s expected energy costs when financing a house. The U.S. Department of Housing and Urban Development would issue updated underwriting and appraisal guidelines for any loan issued, insured, or purchased by the Federal Housing Administration (FHA) or any other federal mortgage loan insurance agency.

The bill establishes two methods for determining expected annual energy costs: average utility costs, derived from the Department of Energy’s Residential Energy Consumption Survey database and adjusted for the square footage of the home, or if available, a qualified, independent energy report of the subject property.

The SAVE Act would help protect taxpayers from another foreclosure crisis; lower utility bills for U.S. households; drive business and job growth in the construction and manufacturing

sectors; expand the accessibility and affordability of energy-efficient homes; and reduce U.S. energy dependence.

For more information about the SAVE Act, visit the Institute for Market Transformation, a non-profit organization dedicated to the promotion of energy efficiency, green building, and environmental protection in the United States and abroad.

Present Value LLC is a worldwide international appraisal and advisory company that provides a range of professional services such as Certified Machinery and Equipment Appraisals, Inventory Appraisals, Asset Verification Services, Business Valuations, and Real Estate Appraisals. Contact us today!

By: Present Value

Additional Reading:

Appraisers Seeking Resources to Determine the Value of Green Buildings

Appraisal Institute Acknowledges It’s Not Easy Appraising Green

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November 1, 2011
by Julie Baker
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How to Safely Ship Equipment

Shipping a large, fragile piece of equipment is never an easy task. The last thing you want to do is be unprepared for the move and end up having your equipment lose significant value due to damage or late arrival. To help you with this difficult undertaking, I asked EquipNet’s resident experts who specialize in complicated shipping projects for their top tips.

Our experts’ suggestions boiled down to these top five pointers:

1. Communication is key for each step of the shipping process.

The number one reason a shipment has problems is that there was a breakdown in communication somewhere along the line. People should strive to over communicate throughout the process. Key communication details are the dimensions, weight, container type and special requirement needed for problem-free shipping.

2. Be sure you have the correct dimensions and weight for the equipment.

One of the most common mistakes people make when shipping equipment is incorrectly communicating the size and weight of the shipment. This can lead to an agency not having the necessary equipment to transport and unload your shipment. In order to avoid delays and added costs, precisely communicate the width, height, depth, weight, and any precautions that need to be taken when shipping the equipment.

3. Factor in extra time if the shipment is crossing an international border.

It’s important to consider the locations the equipment is being shipped from and to. When crossing borders, you must have a customs agent and you’ll need to factor in additional time for paperwork and taxes.

Continue Reading →

October 31, 2011
by Julie Baker
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Happy Halloween!

Dividing up your loot and trading candy after trick-or-treating is one of the best parts of Halloween. Much to the dismay of my dentist, gummy candies were one of my absolute favorites. Check out this video about how gummy candy is made:

The EquipNet MarketPlace has a wide array of confectionary processing and packaging equipment for sale. And don\’t forget: If you need a particular piece of equipment you don\’t see listed on our site, contact a member of the EquipNet sales team and they will search for you: (781) 821-3482 or sales@equipnet.com

October 27, 2011
by Julie Baker
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Survey Finds Most U.S. CPAs Support Giving U.S. Public Companies Option to Adopt IFRS

A recent survey by the American Institute of Certified Public Accountants (AICPA) found that the majority of certified public accounts (CPAs) support optional adoption of the International Financial Reporting Standards (IFRS), the emerging set of globally accepted accounting rules.

The survey showed that many CPAs still think a wait-and-see approach is best in regard to the IFRS. While support for IFRS remains high among AICPA members, the survey found that, in the absence of a clear regulatory timetable, U.S. firms and organizations continue to delay planning and preparation for the global standards.

“It’s clear the profession is looking for more guidance from the Securities and Exchange Commission,” said Susan Coffey, AICPA senior vice president, public practice and global alliances. “But whether or not the SEC decides to incorporate IFRS into the U.S. financial reporting system through an endorsement approach, CPAs support giving U.S. issuers an option to adopt IFRS as issued by the International Accounting Standards Board.”

IFRS requires that a company’s balance sheet recognize all allowable assets and liabilities under IFRS reporting standards, re-classify items that were previously classified under GAAP, and apply IFRS standards when measuring the value of all assets, which

requires a certified appraisal.

Because Present Value LLC has performed machinery and equipment appraisals worldwide, we are very knowledgeable about IFRS accounting principles, and we aim to be at the forefront of the appraisal industry to better serve our clients and partners as they navigate these changes.

Present Value LLC is a worldwide international appraisal and advisory company that provides a range of professional services such as Certified Machinery and Equipment Appraisals, Inventory Appraisals, Asset Verification Services, Business Valuations, and Real Estate Appraisals. Contact us today!

By: Present Value

Additional Reading:

GAAP and IFRS

IFRS Debate Continues: Centre for the Study of Financial Innovation Holds Roundtable on IFRS

SEC Releases Staff Paper on a Possible Incorporation of IFRS into U.S. GAAP

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