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K-V Pharma Protests Hologic Bid for Makena
K-V Pharmaceutical is protesting Hologic Inc.'s "brazen" attempt to circumvent bankruptcy law to get its hands on the rights to Makena. K-V Pharmaceutical filed for bankruptcy last month and stated that Hologic is trying to derail its restructuring efforts in order to reacquire the worldwide rights to Makena. The premature birth drug is crucial to K-V's business and reorganization efforts and without Makena the success in restructuring is questioned.
Hologic developed Makena and sold the rights to K-V Pharmaceutical four years ago. However, Hologic says K-V's missteps and mismanagement are rapidly depleting the drug's value and it wants to reacquire its rights to the drugs. However, K-V said Hologic's allegations of mismanagement are "just plain wrong" and that the company's recent negotiation strategies with state Medicaid agencies and targeted litigation with the FDA are growing Makena's market share and increasing revenue.
http://www.nasdaq.com/article/k-v-pharma-protests-hologic-bid-to-reacquire-drug-20120921-00516
Patients to Report Medical Mistakes?
The Obama administration wants consumers to report medical mistakes and unsafe practices by doctors, hospitals, pharmacists and others who provide treatment. In a flier drafted for the project, the government asks: "Have you recently experienced a medical mistake? Do you have concerns about the safety of your health care?" A draft questionnaire asks patients to "tell us the name and address of the doctor, nurse or other health care provider involved in the mistake." And it asks patients for permission to share the reports with health care providers "so they can learn about what went wrong and improve safety."
In the reporting system envisioned by the administration, patients and their relatives would report medical errors and near misses through a Web site (including Kiosks in health care offices/facilities) and in telephone interviews. For each incident, the government wants to know "What happened?" (See the link to see the questions asked of the patient).
http://www.nytimes.com/2012/09/23/health/new-system-for-patients-to-report-medical-mistakes.html?_r=0&adxnnl=1&adxnnlx=1348765684-C/Sz/461PGMUHTD7h8CZVg
Drug Shortage Easing
To date, there are about 100 drug shortages this year, down from about 180 at the same time last year. In 2011, the FDA tracked 251 shortages, and 181 in 2010. The drop in shortages is attributed to drug manufacturers improving quality, reducing the need for FDA action and recalls. The number of shortages became problematic in the past couple of years when some companies either got in trouble with the FDA or shut plants down entirely to correct quality issues. Even though we have fewer new shortages, some of the firms with problems are still having problems.
http://www.medpagetoday.com/Washington-Watch/FDAGeneral/34935
New Term for Splittable Tablets Coming
How does one define the term functional score and use it to designate only tablets that reliably split into equal portions? This is a question the FDA and the United States Pharmacopeia (USP) are tackling.
Many tablets have an indentation that facilitates breakage into portions but there are no standards or regulatory requirements that specifically address tablet scoring. There will be a new USP "general chapter" on functional scoring in the USP-NF with a planned chapter number less than 1000 so the FDA can declare an approved drug product misbranded or adulterated if it does not satisfy the standards. The USP plans to publish its draft of the chapter in the first half of 2013 for comment.
http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=3789
Drug Companies Face �12 Billion Black Hole as Governments Don't Pay Up
European finances has punched a �12 billion black hole in pharmaceutical firms' balance sheets as cash-strapped governments refuse to pay up for drugs. Greece, Ireland, Portugal, Italy and Spain together have already been propped up to the tune of �5.5bn through price cuts and discounts during 2010 and 2011.
Drug companies have previously complained that they are forced to provide beleaguered nations, arguing they are morally obliged to keep supplying medicines to struggling economies such as Greece despite billions of pounds worth of unpaid bills.
And the wider squeeze on healthcare spending is also threatening to drive down margins in stronger economies. Even relatively buoyant countries such as Germany are forcing pharmaceuticals companies to share the pain of austerity.
http://www.thisismoney.co.uk/money/markets/article-2209254/Drug-giants-face-12billion-black-hole-Governments-dont-pay-up.html
PHARMA Companies Paid $6.6 Billion This Year to Settle Fraud Claims
GSK, J&J and other pharmaceutical companies have paid $6.6 billion this year to settle claims of defrauding U.S. health programs, more than double the amount of 2011, advocacy group Public Citizen said. Common frauds include overcharging government programs such as Medicare and pushing doctors to prescribe drugs for unapproved uses.
http://www.nj.com/business/index.ssf/2012/09/johnson_johnson_other_drugmake.html
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