Regulatory Focus™ > News Articles > Regulatory Reconnaissance (5 November 2012)

Regulatory Reconnaissance (5 November 2012)

Posted 05 November 2012 | By Alexander Gaffney, RAC

Regulatory Reconnaissance is your daily news recap for the regulatory news and intelligence space. Top stories today include new regulations for Massachusetts pharmaceutical compounders, serendipity for an NIH program to repurpose existing pharmaceutical compounds, the first-ever gene therapy product gains approval in the EU, trade problems in Greece and some political races worth watching tomorrow if you're a medical device professional.

United States

(Boston Globe) The Massachusetts Board of Registration for Pharmacy has unveiled new regulations for compounding pharmacies in the wake of a meningitis outbreak. The new rules would allow state regulators to penalize companies failing to meet quality standards and quarantine potentially unsafe products.

(FDA) FDA has submitted its proposed collection sheet for information under the Generic Drug User Fee Act. It now goes to OMB for approval.

(Reuters) Ameridose, the sister firm of the New England Compounding Pharmacy (NECC), has extended its shutdown by another two weeks while regulators continue an inspection of the facility. FDA is already facilitating a voluntary recall of all products manufactured by the facility after a preliminary inspection found sterility problems-the same basic violation that caused the shutdown of NECC.

(FDA) US regulators have approved an expanded label for Xarelto for treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE). The drug had already been approved for a similar, but narrower, indications.

(FDA) FDA sent out a drug safety communication on 2 November stating that the blood thinner Pradaxa did not lead to an increased risk of potentially fatal bleeding events, leading it to make no change to its existing approval.

(FTC) Walgreens probably thought it had a solid moneymaker back in 2008 after selling a generic version of Airborne, a supplement claiming to be able to prevent cold and flu symptoms and germs. Unfortunately, Airborne settled with FTC later that year for deceptive marketing, and Walgreens settled similar charges in 2010. Now FTC is telling consumers they may be due a refund if they purchased the product.

(The Pink Sheet) The National Institutes of Health (NIH) is trying something new: Getting drug sponsors together to repurpose drug compounds for use in new therapeutic areas. The unexpected response, writes The Pink Sheet, is that a bunch of these companies are looking at the same compounds, but for different reasons. To put a number to the serendipity: Out of 160 applications, 16 compounds received at least five applications each.

(The Pink Sheet) Reporting from the RAPS conference, The Pink Sheet finds that FDA's first attempt at an adaptive clinical trial design didn't actually save any time or money.

(Bloomberg) Medical device spinal implant manufacturer Orthofix will settle a kickback lawsuit with a $30 payment to federal officials. Bloomberg reports the company was accused of paying surgeons with schemes including phony consulting work, royalty agreements, travel and prostitutes.

(FDA) Margaret Hamburg explains in this op-ed that her agency is looking to stem the impact of potential drug shortages stemming from the shutdown of pharmaceutical compounder Ameridose.

(Alliance for a Stronger FDA) Steven Grossman of the Alliance explains how an 8.2% cut in FDA's budget-the cut that will take place if the budget sequester gets passed into law in January-will affect the agency's ability to operate.


(Reuters) The European Commission has approved a Dutch biotechnology company's gene therapy drug, the first such therapy in Europe and possible the world, reports Reuters.

(MHRA) UK regulators are calling for comments on the European Commission's new proposal for a clinical trials regulation. The proposal is set to replace the existing Clinical Trials Directive 2001/20/EC.

(BBC) The European Parliament is blasting the European Commission for not moving fast enough to reign in faulty medical devices-and in particular implants-by overhauling the current regulatory system. Of particularly concern is the role of notified bodies, which have come under fire by some publications by not being rigorous enough and acting more as pay-for-approval rubber stamps.

(Reuters) German pharmaceutical manufacturer Merck has announced it will no longer supply Greek hospitals with supplied of its cancer drug Erbitux after it says reimbursement levels were too low and unpaid bills too high.

(Reuters) The pharmaceutical trade organization Efpia has meanwhile stated that its members would agree to cap the total amount paid for future medications if Greek officials agree to pay its outstanding debts to companies-a possible endgame around the problems experienced by Merck (See: above item).

(NY Times) The US' economic sanctions against Iran are reportedly working well-too well, in fact, for many patients who say they are unable to maintain access to some life-saving medications intended to be exempted from export restrictions. As many as six million patients may be affected, according to some estimates.

(Pharma Biz) India's pharmaceutical industry wants the Drug Controller General of India to extend of length of time Certificate of Pharmaceutical Products (CoPP) are valid from two years to three.

(EMA) How do you fill out application forms for certificates of medicinal products? The European Medicines Agency (EMA) has you covered with this guide.

(Pharma Biz) There are healthcare regulations, and then there are environmental ones. Indian pollution regulators are set to crack down on the latter after receiving regular complaints about illegal dumping of effluents in select industrial areas.

(Pharma Biz) Indian generic drug exporters can breathe a sigh of relief, reports Pharma Biz: New regulations banning approval of branded generics will not apply to products intended solely for export.

(PM Live) Yervoy and Zelboraf has gained approval from the UK's National Institute for Health and Clinical Excellence (NICE) after discounting their prices.

(AHWP) The Asian Harmonization Working Party (AHWP) is having their meeting this week. Wondering what they're talking about? Wonder no longer.

Essential Reading

(Forbes) Matthew Herper asks, why don't presidents do more to shape the FDA? Shorter Herper: The public largely doesn't care unless there's a big crisis.

(Bloomberg) Cass Sunstein, former regulations czar for the Obama administration, pens an op-ed in which he touts his former boss's approach to regulatory policy. One of his top points: Obama has looked to harmonize regulations across international borders.

(NYTimes) The blood thinner Pradaxa was the subject of a New York Times article this weekend by reporter Katie Thomas, who looked at whether the drug-a replacement for warfarin-should have been approved given its risks. The problem: Some patients have bled out, and unlike warfarin, there are no antidotes to reverse the blood-thinner's effects.

(JAMA News) A new report assessing the efficacy of 11 rapid flu tests finds varying degrees of accuracy, and cautioned that clinicians must use the tests properly or risk missing the presence of the virus entirely.

(MDDI Online) What are the big political races to watch tomorrow for medical device professionals? MDDI wraps up some of the highest-profile races.

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