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K-V Pharmaceutical Files for Bankruptcy
K-V Pharmaceutical has filed for bankruptcy protection, blaming federal actions that kept it from getting "full value" of a drug aimed at preventing premature births. The company, founded in 1942, lists debts of $728.3 million and assets of $236.6 million in a filing in bankruptcy court in New York.
The company blamed the bankruptcy on its "inability to realize the full value of Makena" because of the FDA's refusal to enforce orphan drug marketing exclusivity for it; the company also said it was hurt by restrictions on reimbursements imposed by state Medicaid agencies. In addition, they blamed restrictions on manufacturing and marketing of its other products that were imposed as a part of a 2009 consent decree with the Justice Department after a recall of products, including some tablets that may have been oversized. In 2010, KV's Ethex unit pled guilty for failing to alert the FDA about manufacturing problems and agreed to pay a criminal fine of $23.4 million. Further, the former CEO Mark Hermelin pled guilty to violating drug labeling laws.
http://www.reuters.com/article/2012/08/04/kvpharmaceutical-bankruptcy-idUSL2E8J42DW20120804
Researchers Say Drug Pipeline 'Crisis' a Ploy
Two researchers have charged that if development of innovative new drugs is lagging, it's largely because the pharmaceutical industry would rather spend its money on protecting the franchises built around existing products.
Financially, the two researchers state that the resources that drug companies devote to discovering new products pale in comparison to their spending on marketing, and on research aimed at tweaking their current drugs, argued Donald W. Light, PhD, of the University of Medicine and Dentistry of New Jersey in Cherry Hill, New Jersey, and Joel R. Lexchin, MD, of York University in Toronto.
Drug firms have long argued that the cost of bringing new drugs to market has become extraordinarily expensive, now averaging an estimated $1.3 billion per new chemical entity (NCE) approved. However, the researchers contend that these arguments are mostly bogus, founded on phony statistics. They have calculated that, far from spending $1.3 billion to develop each successful NCE, drug companies often shell out less than $100 million.
Of the $1.3 billion average figure, "half...comes from estimating how much profit would have been made if the money had been invested in an index fund of pharmaceutical companies that increased in value 11% a year, compounded over 15 years," (J Health Econ 2003; 22: 151-185). Half of the remainder is actually paid by taxpayers in the form of deductions and credits. They state that such companies' actual average expenditure is only about $330 million.
http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/34103
Patients Often Don't Know they May Be Using Drugs 'Off-Label'
Many patients who are being treated with "off-label" drug use are unaware that the medications have not been approved for their specific indications. The off-label drug use situation is explained in a report published online August 6 in the Mayo Clinic Proceedings.
Because doctors are not required to disclose the off-label use of a drug, and are also not liable for off-label drug use, patients are commonly not told that they are taking a drug in a way that is not FDA-approved, the researchers pointed out. However, drug makers are not allowed to promote off-label uses of their drugs. However, they are allowed to respond to questions from healthcare providers and distribute peer-reviewed publications about off-label drug use. The high costs and lengthy process of obtaining FDA approval may deter drug companies from seeking approval for a new drug indication, the researchers suggested.
http://consumer.healthday.com/Article.asp?AID=667431
Micron-Scale Swimming Robots Could Deliver Drugs and Carry Cargo Using Simple Motion
A team of researchers at the Georgia Institute of Technology has used complex computational models to design swimming micro-robots that could overcome challenges to carry cargo and navigate in response to stimuli such as light. These simple micro-swimmers could rely on volume changes in unique hydrogels to move tiny flaps that will propel the robots. The micro-devices could be used in drug delivery, lab-on-a-chip microfluidic systems-and even as micro-construction robots working in swarms. These simple micro-robots were described July 23 in the online advance edition of the journal Soft Matter, published by the Royal Society of Chemistry in the United Kingdom.
http://www.fiercedrugdelivery.com/press-releases/micron-scale-swimming-robots-could-deliver-drugs-carry-cargo-using-simple-m?utm_medium=nl&utm_source=internal
Incorrect Reconstitution Results in Overpayment
Herceptin (trastuzumab) is a Medicare-covered biological drug used to treat breast cancer that has spread to other parts of the body. It is supplied as a multidose vial containing 440 milligrams. A vial of Herceptin reconstituted with bacteriostatic water is stable for 28 days when stored properly. An entire multiuse vial of Herceptin represents 44 units for billing Medicare. However, for multiuse vials, Medicare pays only for the amount administered to a beneficiary and does not pay for any discarded amounts of the drug. Therefore, a payment for an entire multiuse vial is likely to be incorrect.
The providers attributed the incorrect payments to chargemaster errors, clerical errors, and billing systems that could not prevent or detect the incorrect billing of units of service. In some cases, providers could not store unused doses for later use because their pharmacies incorrectly reconstituted the Herceptin using sterile water instead of bacteriostatic water. When this occurred, the providers billed Medicare for the entire vial, including waste.
http://oig.hhs.gov/oas/reports/region3/31100014.pdf
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