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News from CustomVault

for the Pharmaceutical Industry 

Fourth Quarter, 2013 


Hydrocodone Combination Reschedule

Finally Moves Forward




In January of this year, an FDA advisory panel voted to strengthen restrictions on hydrocodone combination drugs, recommending that the FDA make the drugs more difficult to prescribe. A shift from Schedule III to Schedule II seemed imminent. But in March, the FDA warned lawmakers that reclassification could be delayed.


Perhaps in part due to legislative push-back, the process of reclassification is indeed back on track. A statement from Janet Woodcock, ND, Director of the FDA's Center for Drug Evaluation and Research was posted on the FDA website on October 24th that read as follows:   "By early December, FDA plans to submit our formal recommendation package to HHS (US Department of Health and Human Services) to reclassify hydrocodone combination products into Schedule II. We anticipate that the National Institute on Drug Abuse (NIDA) will concur with our recommendation. This will begin a process that will lead to a final decision by the DEA on the appropriate scheduling of these products."  Media coverage at press time, however, was focused on Capitol Hill outrage over the FDA's approval of Zohydro ER from Zogenix; an extended release single entity (pure) hydrocodone product.  Much more to come in 2014.



A Trend to Watch:
The Impact of the Affordable
Care Act on Pharma


Price Waterhouse Cooper recently released an evaluation of the state of the pharmaceutical business and projections for 2020.  Due to anticipated population growth, an aging America, and the preponderance of risk factors like obesity, they forecasted pharmaceutical sales to reach $425 billion by the end of the decade despite a wave of anticipated patent expirations.


However, GlobalData of London asserts that the Affordable Care Act will provide an additional boost to pharmaceutical balance sheets, increasing revenue by a full third by the end of the decade as millions of uninsured Americans secure coverage. Despite expiring patents on blockbuster drugs and a wave of new regulation from the Affordable Care Act that will cost drug makers, their analysis shows that the pharmaceutical industry will reap between "$10 billion and $35 billion in additional profits over the next decade." They therefore project that the U.S. pharmaceutical industry's market value will in fact reach $476 billion in 2020 from $359 billion last year.

Read more.

CustomVault provides an expert, consultative approach to the design, manufacture, delivery and assembly of modular vault systems.

Offering a full line-up of complementary security products including cages, mantraps, bullet resistant equipment, video surveillance, intrusion alarm systems and access control, allows us to offer our clients complete security solutions. Learn more about us by visiting our Website . 

Happy Holidays, 

Rebecca Cicarelli
Marketing Director, CustomVault


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Security Insight:  

 IP vs. Analog Cameras




What is the difference, and is it worth making an upgrade? This is a question that CustomVault hears often. Analog technology is the traditional method of transmitting a relatively low-resolution image over coaxial cable. The two most significant benefits of this technology are the low cost of the product and the cameras' ability to deal with difficult lighting situations. IP Megapixel technology is the digital alternative often associated with television and cell phone cameras. It ultimately facilitates the reduction of overall camera count because IP images are much higher resolution and cover a significantly wider field of view.  Read more. 

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The Word On...
Washington and the Pharmaceutical Supply Chain
Pharmaceutical supply chain security breaches have triggered a renewed focus on this issue in our nation's capitol.  Congress continues to craft a set of national requirements that would protect both patients and manufacturers, allowing for the assignment of problem accountability via a more streamlined and cost efficient approach. 
As they weigh options, House and Senate policymakers are considering  definitions; pedigrees; track-and-trace technologies; serialization; lot- and unit-level requirements; authentication; interoperable data collection and systems; data confidentiality and access; requirements for transaction reporting and notification regarding suspect deliveries; implementation timing; licensure, registration, and accreditation
standards for entities in the supply chain; accountability; cost; and the relationship between federal and state laws.  2014 will certainly be a year of activity with regard to this issue.


CustomVault | (866) 431-7646 | marketing@customvault.com | 4 Research Drive
Bethel, CT 06801

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