Regulatory Focus™ > News Articles > Regulatory Reconnaissance (30 November 2012)

Regulatory Reconnaissance (30 November 2012)

Posted 30 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 international regulatory cooperation for medical device inspections, a new report on FDA's medical device performance over the last two years, EMA's budget gets recommended for discharge by EU legislators, Australia's regulatory calendar for 2013, and some reasons why pharmaceutical theft has decreased so much as of late.

United States

(FDA) US Regulators recently signed landmark agreements with Brazil, Canada and Australia to put into place enhanced regulatory cooperation measures. The first agreement between FDA and Brazil's Anvisa just covers cooperation and communication. A second agreement between all four countries starts to put into place the structure for a Medical Device Single Audit Program (MDSAP) which would see the agencies relying on one another to inspect domestic facilities. (FDA-Anvisa Agreement) (FDA-TGA-Anvisa-Health Canada Agreement) (TGA Statement)

(FDA) A new report out from FDA on its medical device review unit finds that premarket review times for medical devices have begun to speed up for the first time in a decade. Other improvements found by FDA investigators include a smaller backlog of 510(k) applications, an approximately 33% drop in the time it takes to reach a decision on PMAs, and a higher percentage of approved devices relative to total submissions.

(FDA) A new letter from FDA to medical device companies indicates that the agency has launched its new internet-based system for submitting and processing export documents requests, known as the CDRH Export Certification and Tracking System (CECATS). The system will enter Phase II of its implementation scheme in the coming year. (Summary of CECATS)

(FDA) FDA has approved Exelexis's Cometriq (cabozantinib), a drug formulated to treat metastasizing medullary thyroid cancer. The drug was approved through the agency's 6-month priority review program and will be marketed by AstaZeneca.

(Mass Device) Medical device manufacturer Neusoft Medical Systems has received FDA clearance for its NeuViz 64 multi-slice CT scanner, a device marketed as being more cost-effective than its rivals.

(FDLI) A new white paper on the naming convention for biosimilar medicines sponsored by the Alliance for Safe Biologic Medicines, a trade group of mostly branded biopharmaceutical companies, urges FDA to mandate distinct names be given to biosimilar medicines. FDA Law Blog's Kurt Karst explains more here.

(CBO) The Congressional Budget Office answers the long-standing question: just how much money would drug adherence save taxpayers? The answer: a whole lot of money. For every 1% increase in prescriptions filled, total prescription costs would fall 20%.

(Partnership for Public Service) Is there an FDA employee who you think has gone above and beyond the call of duty to protect the public health? The Samuel J. Heyman Service to America Medals-colloquially known as the Sammies-is now open for nominations.

(RPM Report) (Subscription) Michael McCaughan digs into Rep. Tim Murphy (R-PA), the new chair of the House Energy and Commerce Committee's Oversight Subcommittee, to assess how the legislator might act on the implementation of the Generic Drug User Fee Act. FDA might have reason to worry about Murphy's appointment-in a testy exchange with Commissioner Margaret Hamburg, Murphy all but called for her resignation in response to the pharmaceutical compounding scandal.

(Securing Pharma) Fake drugs are getting less fake, and that's posing a problem for both patients and government inspector, reports Nick Taylor. A new government report by the US Department of Commerce finds that "more and more counterfeit pharmaceuticals are using real active pharmaceutical ingredients to trick patients."

(PharmPro) Janssen's investigational TB treatment drug bedaquiline won the split support of FDA's Anti-Infective Drugs Advisory Committee. Though its efficacy was unanimously supported (18-0), its safety profile narrowly won support on an 11-7 vote.

(Washington Post/AP) Consumer advocacy group Public Citizen is calling on FDA to re-inspect several pharmaceutical compounding facilities with existing records of violations. The move comes just weeks after serious violations were found at several Massachusetts-based compounding facilities that also had lengthy histories of repeat violations.

(Pharma Manufacturing) The FDA pharmaceutical compounding saga raises an interesting question for regulators: with the agency already doing so much and taking on new duties, how would it be able to start inspecting the compounding industry without its inspection resources becoming too thin?

(FDA) Regulate any meat-based food products? FDA is out new a new rule regarding the irradiation of food using a 4.5 kilogray (kGy) maximum absorbed dose of ionizing radiation.

(FDA Matters) Are punishments in the US for pharmaceutical-based crimes too lax? Steven Grossman of the Alliance for a Stronger FDA takes a look at the punishment philosophy of China versus that of the US and finds the US lagging in at least one area of understanding.

(FDA) FDA wants to survey veterinary professionals on the drug resistance of some parasites in the hopes of better understanding how such drug resistance is understood, detected, monitored and managed. Also at issue: labeling and marketing considerations for antiparasitic drugs.

(E&C Committee) The House Energy and Commerce Committee has a bunch of new members on it, including five new Republicans introduced by Chairman Fred Upton (R-MI) in a statement on 29 November. It is not yet clear if any of the committee members would sit on the Subcommittee on Health or the Subcommittee on Oversight, both of which have some jurisdiction over FDA's programs.

(NY Times) Ranbaxy has suspended production of its generic version of the drug Lipitor (atorvastatin calcium) after finding small shards of glass in certain lots of the product, and will recall the product. The recall comes just months after a massive settlement was reached between the company and FDA, which put the company under a fairly restrictive consent decree after several of its facilities were flagged by FDA as having quality manufacturing deficiencies. Those facilities in question were not responsible for manufacturing the glass-contaminated generic Lipitor.


(Outsourcing Pharma) Are sponsors negligent in their oversight of clinical research organizations (CROs)? To read a report by industry watcher Access to Medicine Foundation, yes. Gareth MacDonald reports that the group criticized industry for not doing enough to see that their outsourced clinical trials meet the ethical standards established by international treaties.

(EMA) Merck Sharp and Dohme has withdrawn its marketing authorization for Jenzyl (ridaforolimus), an orphan biologic medicine. The withdrawal is the second for a biologic-based medicine this week. On 27 November Marvel LifeSciences Ltd withdrew its marketing authorization for Solumarv, Isomarv and Combimarv, all biosimilar versions of human insulin. Both sponsors said new EMA guidance made it clear to them that they did not yet have sufficient information to support approval.

(EMA) EMA is out with the highlights from its 26-29 November 2012 Pharmacovigilance Risk Assessment Committee (PRAC). It started referral procedures on four products: Almitrine, Diacerein, Hydroxyethyl starch-containing solutions and short-acting beta-agonists. (Pharmalot explains the HES starch background)

(TGA) (Australia) What's Australia's Therapeutic Goods Administration (TGA) up to next year? Wonder no longer. The agency is out with a fairly comprehensive list of both goals and background information.

(TGA) (Australia) TGA is reminding stakeholders that its Mutual Recognition Agreement with the EU regarding conformity assessments for medical devices comes into effect on 1 January 2013.

(PharmaBiz) (India) India's Union health ministry is struggling to collect data regarding serious adverse events occurring in clinical trials despite a directive by the Indian Supreme Court to collect the information to provide it with such information, reports PharmaBiz.

(ENVI) The European Parliament has looked favorably upon EMA's 2011 budget spending just one year after a lengthy fight held up its 2010 budget for months. In a draft opinion issues on 29 November, the Committee on Budgetary Control and the Committee on the Environment, Public Health and Food Safety (ENVI) said EMA's 2011 budget was both cost-effective and devoid of any fraud or irregularities, and recommended its discharge.

(AIFA) (Italy) Italian regulatory officials have signed an agreement with Japan's Pharmaceuticals and Medical Devices Authority (PMDA) to exchange information more freely between the two countries.

(MedTechEurope) In a case last week (22 November 2012), the European Court of Justice carved out an exemption to the Medical Device Directive (MDD) by saying that only products intended by their manufacturer to be medical device are covered by the MDD. Opinions on the impact of the case vary, and Med Tech Europe summarizes some of those opinions here.

Essential Reading

(Eye For Transport) Thefts of pharmaceutical products have plunged both in number and value in recent years. How? A concentrated and wide-ranging effort by companies, detailed in this Eye for Transport piece.

Editor's note: I'm in meetings all morning again. Same deal as always-rather than leave you with an article or two, please enjoy everything that I might otherwise have written about.

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