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FDA Further Restricts Antibiotics for Livestock
The FDA has announced that farmers and ranchers must restrict their use of a critical class of antibiotics in cattle, pigs, chickens, and turkeys because they feel that such practices may have contributed to the growing threat in people of bacterial infections that are resistant to treatment. The drugs in questions are the cephalosporins and include brands like Cefzil and Keflex, which are among the most common antibiotics prescribed to treat pneumonia, strep throat, and skin and urinary tract infections. Ten years ago, the FDA banned indiscriminate agricultural uses of the fluoroquinolones (Cipro). The FDA has not made a final decision on a guideline proposed in 2010 that would edge the agency closer to banning uses of penicillin and tetracycline in feed and water for the sole purpose of promoting the growth of animals or preventing illness that results from unsanitary living conditions. This issue has generated intense controversy among farmers and ranchers who contend that public health officials have exaggerated the danger of agricultural uses of antibiotics to humans.
http://www.nytimes.com/2012/01/05/health/policy/fda-restricts-use-of-antibiotics-in-livestock.html?_r=1&ref=health
India Curbs Price Increases on Imported Drugs
India has announced to foreign pharmaceutical companies that they will no longer be able to increase the prices of their imported products simply by stating that their production costs have increased. In the future, these requests must be justified, stated the National Pharmaceutical Pricing Authority (NPPA) which sets maximum retail prices for drugs imported into India if their manufacture involves any of the 74 bulk drugs whose prices are controlled by the authority. The pricing structure includes a margin of 50% over the drugs production costs if no Indian-manufactured generic equivalent is available, plus a 35% margin if one domestically-produced version is available.
http://www.pharmatimes.com/Article/12-014/India_curbs_price_moves_on_imported_drugs.aspx
Medication Shortages Hit 267 Drugs in 2011, for 5th Straight Yearly Increase
Prescription drug shortages in 2011 increased to 267, well above the prior record and about four times the number of medication shortages in the middle of the last decade. As a comparison, there were only 58 drug shortages reported in 2004. The FDA claims it has prevented more than 100 new shortages in 2011. Recently, there have been new shortages of sedatives widely used in surgery, including Valium, Versed, and lorazepam. Another big problem is the recent shortage of the opioid painkiller fentanyl.
Most shortages involve sterile injectables and are normally inexpensive because they've long been available as generics. The FDA states that the main reason for the shortages is manufacturing deficiencies leading to production shutdowns; other reasons include companies ending production of some drugs with narrow profit margins, consolidation in the generic drug industry and limited supplies of some ingredients.
http://www.washingtonpost.com/business/university-new-medication-shortages-hit-267-drugs-in-2011-for-5th-straight-yearly-increase/2012/01/03/gIQA5vUuYP_story.html
(Editor's Note: This is a great opportunity for compounding pharmacists; formulas for many of these drug shortages are being published in IJPC.)
FDA Approves "Germ-killing" Keyboard
A new self-sanitizing keyboard produced by Viogard retracts into a compartment that uses ultraviolet light to kill germs. The FDA has cleared the Vioguard self-sanitizing computer keyboard for use in hospitals and clinics.
Vioguard LLC is owned by two Microsoft Hardware alums, and their business partners sees its device as an alternative to manual cleaning. After use, the keyboard automatically retracts into an enclosed monitor stand to be bathed in ultraviolet light.
http://www.bizjournals.com/seattle/news/2012/01/03/sharing-a-computer-fda-approves.html
Attention Deficit Drugs in Short Supply: DEA Faulted
ADHD drugs are in such short supply that hundreds of patients complain daily to the FDA that they are unable to find a pharmacy with sufficient drug to fill their prescriptions. The shortages are a result of a troubled partnership between drug manufacturers and the DEA. The DEA establishes manufacturing quotas that are designed to control supplies and minimize abuse. Annually, the DEA accepts applications from manufacturers, analyzes how much was sold the previous year, and then allots portions of the expected demand to various companies.
Officials at the FDA say the shortages are a result of overly strict quotas set by the DEA, which, for its part, questions whether there really are shortages or whether manufacturers have decided to manufacture the more expensive product rather than the generics, creating supply and demand imbalances. The situation has made for a rare open disagreement between two federal agencies.
http://www.nytimes.com/2012/01/01/health/policy/fda-is-finding-attention-drugs-in-short-supply.html?_r=2&pagewanted=1&ref=us
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