Regulatory Focus™ > News Articles > Regulatory Reconnaissance (3 December 2012)

Regulatory Reconnaissance (3 December 2012)

Posted 03 December 2012 | By Alexander Gaffney, RAC

Regulatory Reconnaissance is your daily news recap for the regulatory news and intelligence space. Top stories today include a host of legal developments in the US, a new update to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), India's diagnostic industry calls for regulation and Google's new changes to the way search results show drug information.

United States

(NY Times) The Supreme Court of the US will soon hear a case filed by Myriad Genetics regarding whether human genes may be patented. The company contends the ability to patent genes-which it referred to as "isolated molecules" not found in nature-are necessary to protect innovation, while the plaintiffs-The Association of Molecular Pathology, which is being supported by a host of other groups and organizations-argue the company cannot own patents on the use of DNA. (Reuters) (Pharmalot) (Patent Docs)

(Bloomberg) Pharmaceutical painkiller manufacturer Endo Health has sued FDA in a bid to declare the original-and soon to be generic-version of its Opana extended release painkiller to be dangerous. The drug has since been reformulated to be crush-resistant (Opana ER CRF), and Endo's lawyers contend the non-crush resistant version would be harmful to the broader public health. (FDA Law Blog)

(Pharmalot) Can personal injury lawsuits proceed against manufacturers of generic medications? The Supreme Court will soon hear an appeal by Mutual Pharmaceutical regarding a $21 million judgment it was ordered to pay after a user of one of its products developed Stevens-Johnson Syndrome. The court's decision could have huge implications for manufacturers of all generic pharmaceutical products, reports Pharmalot. (WSJ) (Reuters)

(Med Page Today) One of the most famous manuals of psychiatric disorders, the Diagnostic and Statistical Manual of Mental Disorders (DSM), is now approved in its fifth edition. Changes are in some cases subtle-dimensional assessments to gauge the severity of symptoms-and in others profound. Asperger's Syndrome, for example, will no longer be a separate condition, but will instead fall under a broader categorization of the autism spectrum. Other changes include the addition of binge eating and hoarding as new disorders and the removal of an exemption for diagnosing with depression patients who have just lost a spouse. (WSJ) (MedScape)

(Reuters) The New England Compounding Center (NECC), the facility at the center of an outbreak of fungal meningitis spread through tainted steroid injections, is now under grand jury investigation regarding whether to press criminal charges against the company's executives, reports Reuters.

(Modern Healthcare) (Free Subscription) Just how bad are drug shortages in the US right now? Here's an anecdote by way of Modern Healthcare: "The ongoing national drug shortage has reached such a critical state that the Federal Trade Commission (FTC) has given a city-owned ambulance service permission to buy discounted pharmaceuticals from a local hospital as an 'emergency humanitarian gesture,' even though such sales might potentially violate antitrust laws."

(FDA) FDA is preparing to hold a public meeting regarding nicotine replacement therapies, including the development and regulation of the products. The products are used to combat dependence on tobacco products.

(The Incidental Economist) Drug prices are up-way up, particularly when compared to the price of generic pharmaceutical products. Other experts contend this is the result of changing models in pharmaceutical product development, which have focused more on expensive niche products than on broad-based blockbuster products.

(Med Page Today) "Generic slow-release drugs for seizure disorders appear equivalent to branded versions, researchers said, unlike earlier findings with immediate-release formulations," reports Med Page Today.

(Modern Healthcare) A group of Republican representatives is out with a new bill, the Patient Access to Drugs in Shortage Act, which they say will reduce drug shortages by allowing manufacturers of sterile injectable drugs to increase the price of their products more than is currently allowed. Critics contend price fixing is behind at least some of the current drug shortages, as manufacturers cannot raise prices to deal with manufacturing problems or make costly upgrades until it is too late.


(EMA) The European Medicines Agency is out with a new draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration, including biological data, clinical trials, manufacturing process changes and required patient follow-up

(PharmaBiz) India's diagnostics industry is clamoring for the government to regulate testing labs and the diagnostic industry itself, apparently concerned about the lack of regulation in the sector and its effect on trust in the industry.

(EurekAlert) The University of Manchester (UK), six pharmaceutical companies and a host of other entities are joining together in the pursuit of a project they hope can develop sustainable versions of finite materials used in the development of pharmaceutical products.

(WSJ) Drugmakers are heating up in their pursuit of vitamin and supplement manufacturers, eyeing their growing profits and similar processes as an easy target for growth. "The lines are blurring in the vitamins sector between pharmaceuticals and consumer companies," the article explains. As yet unanswered: What will the trend mean for good manufacturing practices in the supplement sector?

Essential Reading

(Pharma Marketing Blog) Google is out with new non-branded search results for pharmaceutical products. John Mack explains their potential impact on the pharmaceutical sector and, potentially, FDA itself.

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