Regulatory Focus™ > News Articles > Regulatory Reconnaissance (26 November 2012)

Regulatory Reconnaissance (26 November 2012)

Posted 26 November 2012 | By Alexander Gaffney, RAC

Regulatory Reconnaissance is your daily news recap for the regulatory news and intelligence space. Top stories today include a new look into the drug's industry's funding of clinical trials results in the Washington Post, new estimates regarding the effect of the sequester on US Food and Drug Administration (FDA), new insights into the possibilities for the breakthrough products designation pathway, the approval of Tonio Borg as the new head of the EU's Health Commission, and new information on the European Medicines Agency's (EMA) plans for clinical transparency.

United States

(NY Times) FDA and the Consumer Product Safety Commission are coming under fire for their regulation-or lack thereof-of bed rails, a number of which have been associated with hundreds of patient fatalities. The biggest question perhaps remains unanswered: Is the product, which is used to assist patients in pulling themselves into and out of bed, a medical device or a regular product?

(Congress) The House of Representatives and the Senate have both passed the Taking Essential Steps for Testing Act of 2012. The bill would amend the Public Health Service Act (PHSA) to revise testing requirements under the Clinical Laboratory Improvements Act (CLIA)and allow health officials to place labs on probation.

(Washington Post) The saga of the GlaxoSmithKline drug Avandia will likely go down in history as one of the greatest examples of what happens when clinical trials data is improperly withheld from doctors, regulators and patients. But, as the Washington Post reports, industry influence in the publication of data in medical journals is still rife with potential conflicts of interest, and doctors are increasingly wary of company-funded trials results.

(PhRMA) Drug industry group PhRMA's CEO John Castellani wrote an unusually lengthy response to the above Washington Post article, calling it "one-sided," "unfortunate" and "unwarranted."

(SCOTUS Blog) The Supreme Court of the US is back in session, and immediately ruled that a challenge to the 2010 healthcare law's individual mandate could be resurrected and re-heard. The crux of the issue: Is the mandate an unconstitional affront to religious liberty?

(Research! America) (PDF) FDA stands to lose $319 million dollars in 2013 if the budget sequestration process goes into effect , reports a new white paper published by research funding advocacy group Research! America.

(Washington Post) Can a house be a medical device? US regulators may be asking themselves that same question, as so-called "GrannyPods" are becoming an option to care for the elderly.

(Reuters) DHHS Secretary Kathleen Sebelius made headlines last year when she reversed an FDA decision allowing the over-the-counter sale of Plan B, an emergency contraceptive pill. Now the American Academy of Pediatrics is seeking to get around that reversal by encouraging physicians to both support the reversal of the ban and to prescribe the pills to adolescent females in advance.

(Mass Device) An FDA inspection report detailing St. Jude Medical's Sylmar, CA plant has sent the company's shares tumbling after the 483 raised a number of troubling problems first hinted at in an earnings report in October.

(The Pink Sheet) While the breakthrough therapies designation may help some products rocket through the development process, a myriad of other factors may still told up approvals, including chemistry, manufacturing and control issues.

(Fierce Pharma) Indian generic drug manufacturer Ranbaxy has been in the news a lot as of late, and not always for flattering reasons. The latest reason is a recall of its generic version of the blockbuster Lipitor, which is only started selling this year, over concerns that certain lots were contaminated with small glass particles.

(Pharmalot) Yet another pharmaceutical compounding facility has been cited by FDA for reported quality problems. Pharmalot reports an inspection of Alaunus Pharmaceuticals found improper testing and batch documentation at the company's Framingham, MA facility.

(The Pink Sheet) FDA has been busy as of late, and The Pink Sheet notes the agency has been slammed with patent lawsuits as firms jostle for market share. The agency has been hit with no fewer than nine complaints since March 2012, with most legal claims involving market exclusivity contentions.


(EC) (EU) The European Commission has approved the appointment of Tonio Borg as the Commissioner for Health and Consumer Protection. Legislators approved his appointment 386-281, with 28 abstentions.

(EMA) (EU) EMA's clinical trials transparency workshop wrapped up on Friday, 23 November. Next up: EMA will be establishing policies in five different areas-patient data protection, data formats, rules of transparency, good analysis practice and legal aspects of transparency. Initial recommendations are expected by April 2013.

(EFPIA) (EU) In a position paper on EMA's transparency measures, industry trade group EFPIA seemed to favor less transparency, arguing that existing measures were largely sufficient.

(Pharmalot) (UK) Is the UK's National Health Service too slow to approve new medicines for use? Novartis CFO Jon Hymonds thinks so, and is calling on officials to act more quickly and with greater consistency, reports Pharmalot.

(Reuters) (EU) Swiss manufacturing giant Roche is seeking to disarm a growing public relations brouhaha over the non-publication of its clinical trials data for Tamiflu, stockpiles of which have been purchased by many governments to guard against an outbreak of pandemic influenza. The problem: critics, including the British medical journal, contend it isn't very effective. Roche's proposed solution, reports Reuters, is to set up a multi-party advisory board to review Tamiflu's efficacy data.

(Fierce Medical Devices) Chinese regulators continue to grapple with issues related to regulatory capacity-the ability of regulators to review new products and manage the safety of existing ones. Part of that problem is related to training, as regulatory systems take time to become established. Chinese medical device regulators are about to receive training from an unusual source: a company they will soon regulate.

(PharmaBiz) India's Drug Controller General will meet with officials from across the country to assess a regulatory mechanism intended to oversee a vaccine manufacturing program, reports PharmaBiz.

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