On Nov. 30, 2011, the patent for Lipitor, the cholesterol-lowering drug that defined the term “blockbuster,” expired. Over its lifetime, it is estimated that Lipitor generated over $100 billion in sales for its parent company, Pfizer, since its introduction in 1997. Read more »

Drug shortages are an acute problem that keeps getting worse. Last year, about 211 drugs were in short supply, which was a new record. This year, the number of new drug shortages already has reached 213, according to the University of Utah Drug Information Service. As a result, many patients now have limited access to crucial drugs, such as cancer therapies and medicines for potentially lethal infections. And a Congressional committee is now investigating what appears to be an insult added to this injury. Read more »

In 2008, a shortage of pig intestines, used in the manufacture of the blood anticoagulant heparin, was associated with the drug product’s contamination in China and led to many deaths around the globe. This event demonstrated the significance of a shortage of supplies needed to manufacture a particular drug and its effect on public health. Read more »

KV-Pharma’s ill-advised pricing of its FDA-approved synthetic progesterone has caused Congress to scrutinize the pricing of other newly-approved versions of old drugs. In an effort to bring such legacy medications into compliance with modern requirements for drug safety and efficacy, FDA offers incentives in the form of patent protection to companies that run older drugs through the appropriate clinical trials and seek FDA approval. URL Pharma markets an FDA-approved gout medication called Colcrys, the active ingredient of which is colchicine, a medication so old that it predated the FDA’s drug safety laws. URL Pharma won approval for their drug in July 2009 and set the price at almost $5 a pill compared with pennies a pill for unapproved versions of colchicine, which FDA ordered be removed from the market once the approved drug became available. URL Pharma vigorously defended their patent after approval and also defended their pricing, saying that it was in line with other approved gout medications and that running the clinical trials provided important safety and dosage information.

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This blog post was written by Amy Ritter.

Drug maker KV Pharmaceuticals has been in the news concerning pricing of its newly approved drug, Makena.  Makena, while newly approved, is a version of a very old drug, synthetic progesterone, which had previously been available to consumers for as little $10-$15 a treatment through specialty pharmacies that compounded the drug on site.   Read more »

After rejecting two obesity-drug candidates in recent months, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended two weeks ago that the agency approve a third drug, Contrave (naltrexone sustained release [SR]/bupropion SR) by Orexigen Therapeutics (San Diego). Members of the expert panel voted 13–7 to approve the drug, but recommended that additional studies be conducted to investigate potential heart risks. Read more »

McNeil Consumer Healthcare, a business unit of Johnson & Johnson (New Brunswick, NJ), failed to ensure the quality of over-the-counter consumer products, according to the Form 483 report released by the US Food and Drug Administration on Wednesday. Read more »

China said it will work to crack down on counterfeit products such as software, music, organic corn, and pharmaceuticals, according to an article from the Associated Press. The government will launch a six-month campaign focused on eradicating sales of illegally copied and fake goods, said Jiang Zengwei, a deputy commerce minister, at a news conference earlier this week. Read more »

The wait for the release of a new weight-loss drug got longer recently as regulatory decisions were not in favor of fat-fighting treatments. The US Food and Drug Administration decided in October not to approve two anti-obesity treatments, sending complete response letters (CRLs) to the drugs’ sponsors.  Read more »

A new report, Phony Drugs, Real Solutions: Practical Anti-counterfeiting Considerations, by technology product design and development firm Cambridge Consultants, gives an update of the problem of counterfeiting and diversion of pharmaceuticals and offers solutions to manufacturers for protecting their brands and consumers. The report’s authors conducted in-depth interviews with leaders from pharmaceutical and biotech sectors, as well as technology developers and industry bodies. Read more »