Regulatory Reconnaissance (27 November 2012)

Posted 27 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 planned meeting to address the regulatory framework for pharmaceutical compounding, the delay of two USP standards, a new FDA compliance guide for grouped generic supplements, a new EU plan to address drug shortages, a new report from French regulators regarding medical device regulations, and a promising power source for future medical devices.

United States

(FDA) Regulators have announced a planned meeting to address gaps in the regulatory framework for pharmaceutical compounding after an outbreak of fungal meningitis has left hundreds injured and dozens dead.

(FDA) A briefing document for FDA's Blood Products Advisory Committee meeting for 5 December 2012 has now been posted. The document primarily addresses the evaluation of blood, organs and tissue donors for infectious diseases, and whether new technologies may be applied to the screening process.

(FDA) A new FDA Manual of Policy and Procedures from the Center for Drug Evaluation and research regards the processing of requests for the review of grouped supplements by the Office of Generic Drugs.

(Philadelphia Enquirer) In response to a January 2011 FDA directive, Abbott will reduce the amount of acetaminophen found in its prescription pain medicine Vicodin, which is a combination of hydrocodone and acetaminophen. The change will likely spur generic companies to do the same to maintain bioequivalency.

(Law 360) Lost in the news during the Thanksgiving holiday last week was a reversal of a Massachusetts policy that had banned medical practitioners in the state from receiving gifts of food or alcohol from the pharmaceutical or device industries. The ban had earned the ire of the restaurant industry, which lobbied to reverse the ban. On 21 November, the MA Public Health Council put the finishing touches on the new policy, which allows the gifts.

(NY Times) A news analysis by the Times finds that St. Jude Medical, a medical device manufacturer well known-perhaps infamously so-for its Durata heart defibrillator leads, may have irreparably harmed its reputation by seeking to bury some unflattering information regarding Durata.

(In Pharma Technologist) Two US Pharmacopeia standards--<232> elemental purities limits and <233> elemental impurities procedures-have been delayed because of appeals filed by a number of industry groups, including the Generic Pharmaceutical Association.

(Fierce Pharma Manufacturing) Avastin made headlines earlier this year when FDA officials found counterfeit copies of the drug circulating throughout the US. New information now points to some of those "counterfeit" copies actually being legitimate, manufactured by Roche but not at an FDA-approved manufacturing facility.

(Coalition for Healthcare Communication) If you read FDA's untitled letters last week, you were probably in for something of a surprise. That's because FDA issued two letters in as many weeks regarding press materials-a highly unusual occurrence, noted CHC.

(FDA Law Blog) The Federal Trade Commission (FTC) has filed an amicus curiae brief in support of a suit against Mylan Pharmaceuticals, which a complaintant argues has purposefully made product reformulations for the sole purpose of constraining competition. Those actions, FTC argues, are anti-competitive, and thus illegal.

(GAO) The Government Accountability Office says the US Customs and Border Protection agency, the department in charge of making sure counterfeit or dangerous products-including pharmaceuticals and medical devices-do not enter the US illegally, is in need of some changes. Specifically, the agency's risk-based monitoring approach, known as the Automated Targeting System (ATS), is in need of validation and refinement.

(WSJ) FDA regulators generally feel that Johnson & Johnson's tuberculosis drug Bedaquiline is safe and well-tolerated, reports the Wall Street Journal.

(NY Times) The US Preventative Services Task Force (USPSTF), an advisory committee famous for its influential and controversial decisions, will not recommend all baby boomers be tested for Hepatitis C, a blow for a number of companies who now have promising Hep C products in their pipelines.


(EMA) (EU) The European Medicines Agency has released a plan to address drug shortages resulting from manufacturing disruptions, the likes of which have already caused massive shortages of some crucial drugs in the US. The plan, detailed in a reflection paper, details fourteen options for EMA to take, sorted into short- and long-term actions.

(EMA) (EU) Regulators have released two draft concept papers regarding, respectively, the possible revision of Annexes 17 and 15 of the Good Manufacturing Practices (GMP) guide. EMA said both need to be changed to "reflect changes in regulatory and manufacturing environments."

(In Pharma Technologist) Switzerland may be home to some of the EU's largest companies, but for onow its exempt from one of its newest rules. Gareth MacDonald reports that active pharmaceutical ingredients manufactured in the country will be exempt from written confirmation requirements intended to assure the quality of APIs in adherence to good manufacturing practice regulations.

(ANSM) (France) French regulators have submitted a report to the legislature regarding the safety of medical devices in the country. Regulators have been reeling from the effects of a scandal involving counterfeit breast implant products manufactured by the now-defunct company Poly Implant Prothese. The report (PDF, in French) includes regulatory recommendations and suggestions for improvements.

(CDSCO) (India) Indian regulators are out with a final guideline on its recall and rapid alert system, just weeks after releasing the draft version of the guideline for public comment. For an explanation of the system, see Regulatory Focus' earlier story on the guideline.

(Outsourcing Pharma) India's government is planning to register ethics committees, clinical investigators and contract research organizations (CROs) after a series of scandals have rocked the pharmaceutical industry in recent years. Legislators recently granted regulators the authority to require registration, and they plan to act soon, reports Natalie Morrison.

(SFDA) (China) China's FDA announced the release of a summary of all illegal drug, medical device and health food advertisements released during the third quarter of 2012. Regulators noted 6,102 instances of illegal advertising.

(BBC) (UK) A UK legislator has suggested that in the future, from patients should be forced to pay for their own drugs if their ailment is the result of a "lifestyle" problem-e.g. Diabetes. Like many regions and countries, the UK is grappling with increasing costs associated with the treatment of chronic and costly conditions.

(EMA) (EU) Marvel LifeSciences Ltd has withdrawn marketing authrorization application for three of its biosimilar human insulin products after the company said it neeed time to repeat and resubmit bioequivalence, pharmacokinetic and pharmacodynamics data using a planned new insulin guideline.

(Pharma Africa) (Ghana, Kenya) Germany will fund a UN project aimed at supporting the production of generic medicines by local companies in Ghana and Kenya starting in January 2013, reports Pharma Africa.

Essential Reading

(Securing Industry) Why were some non-governmental organizations and healthcare researchers with a particular interest in stopping counterfeit pharmaceutical products stopped from attending a summit of World Health Organization researchers? Some advocates are blaming Indian government officials, reports Securing Industry's Nick Taylor in a piece from last week.

(Eurek Alert) A new study of direct-to-consumer advertising finds that the advertising has generally assisted consumer health. No information was available from the press release regarding methods or sample size.

(WSJ) The next big thing to power your medical device? You. The JournaI reports that heat, sound and movement energy could be the future power sources for devices, saving patients from costly and dangerous surgeries to replace deficient or run-down batteries.

[Editor's note: It's the budgeting and planning season here at RAPS, so I'm in meetings all morning. Rather than leave you with an article or two, I leave you instead with this. Enjoy.]

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles