What Expiration? Your Drugs May Last A Long Time - from Pharmalot

What Expiration? Your Drugs May Last A Long Time

from Pharmalot by Ed Silverman

Next time you decide to toss that prescription medicine because it appears to have expired, you may want to think twice. Why? A new analysis indicates that some prescription drugs retain their potency long after the expiration date, and the finding also suggests that the healthcare system could save untold oodles of money if expiration dates were sufficiently extended.
To wit, a team of researchers analyzed 14 different medications and found that 12, or 86 percent, tested at concentrations that were at least 90 percent of the amount on the labeling. Three actually had concentrations that exceeded the labeling; just two medications had less than 90 percent of the labeled concentration, according to a research letter published in the Archives of Internal Medicine (read here).

Bill includes reauthorization of PDUFA, which adds fees for generic and biosimilar developers.

from Genetic Engineering & Biotechnology News

Insight & Intelligence™ : May 23, 2012

FDA Reform Legislation Emerges as Exception to Washington Gridlock

The fifth five-year authorization of the Prescription Drug User Fee Act (PDUFA V) is shaping up as a welcome exception to the rule that in a presidential election year, Congress cannot get much of anything done until after the votes are counted in November. Well before Election Day, the Senate and House of Representatives are expected to hammer out and pass a single FDA reform bill that includes PDUFA V.

“We need to enact this user fee bill by the end of June. We are on track to accomplish this goal,” Rep. Fred Upton (R-MI), chairman of the House Energy and Commerce (E&C) Committee, said. He has called for sending a bill to President Barack Obama before July 4. The Senate moved its bill onto its calendar for floor action; the House is expected to do likewise.

The Senate and House have produced two very similar versions in recent weeks. “I would say it’s pretty surprising how significantly they lined up,” Nancy Bradish Myers, president/founder of Catalyst Healthcare Consulting, told GEN. “The politicians realized that each one of these user fee agreements had good agreement between the agency and industry. They realized that with an election year, if they wanted to go home and claim to have done something significant on the healthcare front that actually helps people get the medicines they need, that a bipartisan agreement needed to be done carefully and quickly.”

for complete article, please visit http://www.genengnews.com/keywordsandtools/print/3/27255/

US Spending on Prescription Drugs Increased Moderately in 2011

US spending on prescription drugs increased moderately in 2011 reflecting increased generic-drug incursion and lower spending on prescription drugs. Pfizer retained its number one position of the top company of US prescription drug sales, and the generic-drug company Teva Pharmaceutical moved into the top-five companies of US prescription drug sales.

Total healthcare system spending on medicines in the US reached $320 billion in 2011, up 3.7% in nominal terms or 0.5% on a real-per-capita basis, according to a recent report by the IMS Institute for Healthcare Informatics. Branded medicines spending grew 2.2% on a nominal basis and reflected the impact of $14.9 billion lower spending on products that lost their patent exclusivity. In 2011, spending for brands launched within the past two years was $12.2 billion, compared with $8.5 billion in the year-earlier period. Spending on generic drugs, which now account for 80% percent of dispensed prescriptions, increased $5.6 billion in 2011, according to IMS. Overall spending on medicines continued to be concentrated on traditional small- molecule oral pills dispensed through retail pharmacies, even as specialty drugs and biologics experienced higher growth.

http://www.pharmtech.com/pharmtech/News/US-Spending-on-Prescription-Drugs-Increased-Modera/ArticleStandard/Article/detail/768291?contextCategoryId=35097&ref=25