Regulatory Focus™ > News Articles > Regulatory Reconnaissance (25 October)

Regulatory Reconnaissance (25 October)

Posted 25 October 2012 | By Alexander Gaffney, RAC

Regulatory Reconnaissance is your daily news recap for the regulatory news and intelligence space. Top stories today include more guidance for sponsors of generic drug applications, a damning new report from the Senate Finance Committee, a discussion draft of national track and trace legislation, a string against EU notified bodies leads to calls for reform, and questions about who might lead the US' health regulators under a Mitt Romney administration.

United States

(Regulatory Focus) The Senate's HELP Committee has released a discussion draft of a proposed piece of legislation intended to establish a national track and trace plan for pharmaceutical products. The original plan, slated for inclusion in the FDA Safety and Innovation Act, was scrapped at the last minute due to disagreement over three key principles.

(FDA) Regulators released the fee schedule for generic drug product applications-both new and existing-yesterday. Today, the agency released a new question-and-answer document detailing some of the more common questions not answered in the guidance.

(Regulatory Focus) Medtronic today found itself under fire from the Senate Finance Committee after legislators released a report indicating that the company, which manufacturers medical devices, had worked with authors of ghost-written studies to minimize potentially concerning adverse event data. The company said it vigorously denied the claims.

(The Pink Sheet Daily) Those generic user fees are lower than expected thanks to a higher expected volume of applications, reports The Pink Sheet Daily.

(NEJM) Why do doctors who know a patient is likely-almost certain-to abuse an opioid medication prescribe it to a patient anyways, asks The New England Journal of Medicine. A few reasons: a pain-centric ethos, reimbursement models and lack of training, opines one group of researchers.

(Friends of Cancer Research)  Along with the Brookings Institute, the Friends of Cancer Research is preparing to conduct a conference on clinical cancer research featuring FDA Commissioner Margaret Hamburg, CDER Director Janet Woodcock, and Clinical Science Deputy Director Bob Temple. Free.

(FDA) FDA's weekly enforcement report for 24 October 2012 is now online. Notable: Class I recall initiated for Ethicon Endo-Surgery medical device.

(Med City News) Ariad Pharmaceuticals' leukemia drug ponatinib has received priority review status from FDA regulators, the company said on Wednesday.

(NY Times) The FDA doesn't regulate the expiration date used by cosmetic manufacturers on their products. They probably should, says a new piece in the New York Times.

(PharmExec) Drug products approved via FDA's 505(b)(2) pathway have exploded in recent years, outpacing 505(b)(1) applications every single year since 2006.

(Mass Device) True to its earlier prediction, St. Jude Medical has received an as-yet-unpublished warning letter from FDA regarding one of its manufacturing facilities located in California. The letter evidently lists 11 observations-not an insignificant amount.

(Pharmalot) Generic drug maker Amneal has petitioned FDA to deny a citizen petition from Reckitt Benckiser, which is trying to deny the generic drug maker's attempts to manufacture a lower-cost suboxone tablet.

(FDA) A supplement manufacturer has entered into a consent decree with FDA after being found guilty of "repeated violations and current good manufacturing practice" by FDA.

(Pharmalot) Anti-HIV advocates want license to manufacture Norvir, an HIV medication manufactured by Abbott Labs, due to its expensive price. The drug has increased four-fold in price since 2003, reports Ed Silverman, and critics are furious at the company.

(Regulatory Focus) Government officials recently restricted the ability of regulators to travel in a bid to save hundreds of millions of dollars each year in travel costs. But could the cutbacks have a higher cost for FDA's regulatory capacity?

(Regulatory Focus) NIH is getting ready to publish a new list of medicines to be considered under a law aimed at reforming the way the government promotes pediatric research on pharmaceutical products.

(Regulatory Focus) The compounding crisis continues, with 24 dead from fungal meningitis spread through tainted compounded medicine and investigations being launched and called for from every corner of the political universe.


(Regulatory Focus) The Asian Harmonization Working Party (AHWP) has released a new 8-year plan it says will help expand the harmonization body's reach, influence and ability to assist emerging regulatory agencies around the world. (Asia)

(The Telegraph) A joint undercover investigation by The Telegraph and the British Medical Journal found several officials working for notified bodies agreeing to hide the true original of their made-up device. The investigation has prompted an outcry from safety advocates and calls for reform. (Europe)

(MHRA) British regulatory officials responded to The Telegraph's article, saying it was supportive of reforms to the notified body system and noted that proposals to do so are already in the works. (UK)

(PMLive) Tonio Borg is the likely successor to recently ousted EC Health Commissioner John Dalli, according to reports of conversations had between EC president John Barroso and Borg. Borg currently serves as deputy prime minister of Malta. (Europe)

(EMA) The European Medicines Agency's 2010 budget has finally received approval by the European Parliament. It had been held up over concerns that it did not have sufficient conflict of interest safeguards in place, concerns about which have plagued the agency for years. (Europe)

(PMLive) The UK is looking into changing the law to allow pharmaceutical companies to conduct trials in the country using medicinal products patented by other companies without the risk of being sued, reports PMLiVE. (UK)

(MHRA) UK regulators now have new power to regulate the activities of wholesalers thanks to a recently-decided court case, said MHRA. What it means: Wholesalers can no longer purchase products from unlicensed pharmacies. (UK)

(Cosmetics Design Europe) The US may be in the midst of a crackdown on marketing claims made by cosmetics companies, but who says they get to have all the fun? The UK has jumped into the fray, censuring Dior for an advertisement featuring Natalie Portman. The problem: Too much digital re-touching, which obscured the true effect of the mascara product.

(EMA) A new concept paper out from EMA calls for the revision of the guideline of testing and evaluating the efficacy of antiparasitic substances for keeping ticks and fleas off of cats and dogs. (Europe)

(Reuters) Pfizer's new lung cancer drug, Xalkori (crizotinib), has received conditional approval in the EU, just months after receiving similar approval in the US. (Europe)

(Economic Times) India's drug reimbursement officials are struggling with how to implement a new pricing mechanism for essential drugs, and have called for the Supreme Court to weight in before it makes any changes. (India)

Essential Reading

(Nature) Increasing amounts of research indicate that some drugs-endocrine disruptors, in particular--are highly toxic, even at low doses. Are regulators blind to the risk, or are the studies tilting at windmills? Nature reports.

(CNN) Whistleblowers are an increasingly important part of the government's strategy against fraud, waste and abuse. But as CNN Radio reports, it's far from easy, even when you have a solid case.

(California Healthline) Dan Diamond asks, who might take over the US Department of Health and Human Services in a Mitt Romney administration? One former FDA official, Scott Gottlieb, seems a likely candidate, says Diamond.

(Reuters) One of the standards of care for cancer patients is treatment with chemotherapy. But are patients' expectations for the treatment too unrealistic? Reuters reports on a new study showing they likely are.

(Modern Healthcare) Generic drugs saved consumers a considerable amount of money during the recent economic downturn, a new study finds.

(Outsourcing Pharma) A new studies suggests that there is a genetic basis for patients who respond to the placebo effect-a positive response due to stimuli that ought not to cause any effect. The findings could have implications for the design of clinical trials, reports Outsourcing Pharma.

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