Regulatory Focus™ > News Articles > Regulatory Reconnaissance (3 January 2013)

Regulatory Reconnaissance (3 January 2013)

Posted 03 January 2013 | By Alexander Gaffney, RAC

Regulatory Reconnaissance is your daily news recap for the regulatory news and intelligence space. This edition recaps a combination of today's top regulatory stories, as well as many from late last week when many readers-and Regulatory Focus-were on holiday.

United States

(FDA) Regulators have released the initial, tentative schedule of all advisory committee meetings scheduled for 2013.

(Qmed) The device industry was betting big that a part of the fiscal cliff deal would include a measure to repeal the impending 2.3% medical device excise tax. That didn't happen, and now the industry is regrouping to figure out what comes next.

(FDA) Regulators have released an updated abbreviated new drug application (ANDA) filing checklist for submissions using the common technical document (CTD) or electronic CTD (eCTD) format.

(FDA) FDA is out with a new batch of warning letters, this one with a bunch of warnings for promotional and advertising violations.

(FDA) The Tissue Reference Group (TRG) of the FDA has updated its annual reports page detailing what recommendations it has made during the past year. Several new types of tissue products are recommended by the TRG as falling under FDA's 21CFR 1271.1-2 authority.

(The Pink Sheet) Drug shortage notifications currently apply to pharmaceuticals but not-as Derrick Gingery points out-to biologics. And that discrepancy is causing FDA to consider whether it wants to extend the requirement.

(Fierce Pharma) Manufacturer Mylan's attempts to snatch the 180-day exclusivity for Lipitor away from generics manufacturer Ranbaxy Laboratories has failed, with a court saying FDA acted properly when it approved Ranbaxy's generic products.

(NYTimes) Innovative manufacturers of painkillers are working to prevent generic versions of their older, less abuse-resistant drugs from reaching the market as generics. The effort has raised a number of questions, most whether or not the existing versions of the drug are truly safe.

(FDA) Regulators are preparing to hold a meeting on Minimal Residual Disease (MRD) detection and how it could be used as a biomarker to evaluate new drugs to treat chronic lymphocytic leukemia.

(MMM News) Transparency Life Sciences has won approval for an IND that it says was partially "crowd-sourced"-reportedly the first time a clinical trial protocol using the method has won approval.

(FDA) A form 483 sent to RTI Biologics, a Florida-based manufacturer, notes a laundry list of sterility concerns found at the company's manufacturing facility, including hundreds of colony-forming units (CFUs) of fungus and bacteria in addition to unsterile water used for manufacturing.

(Dept. of Justice) Victory Pharma will pay the US Department of Justice $11.4 million to resolve kickback allegations, DOJ has announced. The move is connected to allegations that the company illegally promoted its drug products using kickbacks to prescribing physicians.

(AP) Pharmaceutical companies are profiting-big time-off a drug that should be selling nearly as much as it is. The drug, human growth hormone, or HGH, is regularly abused or misused by those looking to delay the effects of aging, reports the AP.

(Fierce Medical Devices) A high-profile patent dispute over "patient monitoring equipment" could set a big precedent, observes Fierce Medical Device's Mark Hollmer. At issue: can someone patent the concept of collecting data from a device that patients wear?

(NPR) Congress convenes its 113th session on 3 January 2013, and for the first time in forty years, Rep. Pete Stark (D-CA) will not be involved in crafting healthcare legislation-or any legislation, for that matter.


(The Hindu) India's CDSCO has been slammed yet again-a regular occurrence in 2012-for failing to crack down on uncontrolled clinical trials, part of a long-running investigation into the conduct of trials in the country.

(Reuters) France may curb the use of certain oral contraceptives manufactured by Bayer-the same products frequently the focus of concerns in the US.

(MedIndia/The Guardian) India is also denying reports that its companies have been sending counterfeit medicines to Africa, saying that "no fake medicines have been sent from India to the continent of Africa."

(Pharmalot) EMA's efforts to become more transparent are paying off in a big way, reports Ed Silverman. The agency has, according to a research letter, released more than 1.6 million pages of documents relating to the conduct of clinical trials.

(PharmaBiz) Iran will begin to import many of its essential drug products from India in a big to ease severe shortages resulting from international sanctions, reports PharmaBiz.

(Health Canada) Canadian regulators have released an overview regarding good manufacturing practice inspections conducted during the last five years.

(MHRA) It's been one year since the PIP breast implant scandal broke across the EU. MHRA breaks down the numbers on what's happened since then and what it means for patients and industry alike.

(Eye for Pharma) England's National Health Service is preparing to go after "the unnecessary prescription of branded drugs" in an effort to save money, reports Eye for Pharma.

(Securing Pharma) Pakistan-which just recently formed its own drug regulatory authority-is in the midst of a rather considerable crisis. Dozens of people have died as the result of tainted cough syrup, and Pakistani courts have ordered a ban on the sale of the product.

Essential Reading

(FDA Law Blog) Could a dog be considered a medical device? Very possibly, writes Jennifer Newberger and Jeffery Gibbs in the FDA Law Blog.

(Reuters) Generic drug products that have a different color than the products they reference are less likely to be taken, particularly when a consumer has switched from the branded to the generic, says a new study.

(Forbes) How does a $300,000 per-year drug come to cost that much? Forbes' Matthew Herper takes us inside some of the pharmacoeconomic considerations companies are working with when they price drugs for orphan and ultra-rare populations.

(Reuters) The strategy of marketing ultra-rare and ultra-expensive products seems to be paying off for companies, some of which are earning billions each year despite the small pool of patients. Is this is an unsustainable trend, or will we soon see $1 million per-year medicine on the market?

(WSJ) Another byproduct of higher drug costs: more counterfeiting. The Wall Street Journal's Jeanne Whalen and Benoit Faucon explore how the growing threat of counterfeit cancer drugs is affecting the industry and patients.

(Fierce Health IT) A new computer model promises to be able to predict the side effects of hundreds of drugs, reports Fierce Health IT.

(Fierce Pharma) A new study in the New England Journal of Medicine notes that drug shortages have harmed patients by reducing the likelihood that they will be cancer-free two years after being rid of high-risk Hodgkin lymphoma, reports Fierce Pharma.

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