Regulatory Focus™ > News Articles > Regulatory Reconnaissance (13 November)

Regulatory Reconnaissance (13 November)

Posted 13 November 2012 | By Alexander Gaffney, RAC

Regulatory Reconnaissance is your daily news recap for the regulatory news and intelligence space. Top stories today include an impending legislative hearing on the meningitis outbreak crisis, FDA criticism of the supplement industry, EU legislators panning Tonio Borg in a hearing, a Croatian crackdown on a pharmaceutical company, and the ethics of using leftover blood for medical testing.

United States

(House) US legislators will spend the better part of tomorrow grilling FDA's Margaret Hamburg and the owner of the New England Compounding Center regarding an outbreak of fungal meningitis. The hearing will be streaming online on the House's website starting at 10:00 AM.

(House) A report out from House committee members indicates long-standing problems with the New England Compounding Center (NECC) and its owners, which the report claims stymied FDA regulators time and again in their attempts to inspect its facilities.

(House) Michael Burgess's (D-TX) AIR Act, which would allow the sale of Primatene CFC-based inahlers, will now come to a vote after Thanksgiving. It was tentatively scheduled for the week of the 13-16th.

(FDA) Ever wonder what FDA's User Fee Collection System is or what information it collects? FDA's Federal Register posting today provides a quick overview, along with how that data is used in compliance with the Privacy Act.

(CDISC) CDISC: "FDA representatives in Baltimore this year announced that … FDA will begin requiring standardized electronic submissions for evaluation of new therapies/products by 2017."

(PharmaFile) Hospira is on track to end shortages of Propofol, an anesthetic infamous for its use in executions and the accidental death of pop star Michael Jackson. Hospira has been experiencing problems at three of its manufacturing facilities, leading to recalls and supply problems, reports PharmaFile.

(LA Times) California legislators are looking to require coroners to report all deaths caused by prescription drug abuse reported to the state medical board after a report indicated some doctors are behind many overdose fatalities.

(NY Times) In response to public pressure, Sanofi has cut the price for one of its cancer medications, Zaltrap, in half. The drug is used as a second-line cancer medication, but some doctors have questioned both its high price and minimally effective. The NY Times editorial board expressed its support in this article.

(Natural Products Insider) FDA's top supplement regular, Daniel Fabricant, still thinks the industry needs to get on board with good manufacturing practice (GMP) compliance and appropriate marketing claims, among other issues.

(Advamed) Trade industry group AdvaMed has a lot-a LOT-of recommendations for FDA's unique device identification (UDI) rule.

(Reuters) Pfizer will pay nearly $70 million to settle an investor lawsuit that it under-stated the risks of its antidepressant Pristiq.

(Med City News) A small study of medical device makers finds most are dissatisfied with FDA, though the statistical significance of the study leaves much to be desired. The reasons for their dissatisfaction mostly relate to problems with communication, reports Med City News.

(Mass Device) Could DHHS Secretary Kathleen Sebelius stay for a second term? Mass Device reports the decision to stay another four years would be unusual. The unanswered question: Does Sebelius want to see health care reform through to its implementation stage?


(EMA) Need help translating a document? EMA has a new guidance out on who you should contact depending on which state your medication must be marketed in and what type of product it is.

(Reuters) EU legislations may think Commissioner-designate Tonio Borg is capable, but that doesn't mean they favor his politics. Borg, a citizen of Malta, is a devout Catholic and has reportedly made contemptuous statements about homosexuals and abortion rights. Reuters notes that if the legislators vote not to confirm Borg, while non-binding, would prove to be an embarrassment to the European Commission, still reeling from the resignation of John Dalli.

(Reuters) Croatian officials have reportedly arrested the management of an as-yet-unnamed pharmaceutical company for suspected bribery. Hundreds of officials and doctors could eventually become ensnared in the probe, sources told Reuters.

(WHO) The World Health Organization is out with its November Pharmaceuticals Newsletter, which details a number of safety issues made known to regulatory authorities across the globe.

(WHO) Another World Health Organization report details the safety monitoring of medicinal products, including the reporting of adverse drug reactions (ADRs) and the use of national reporting systems.

(Biosimilar News) The Association of the British Pharmaceutical Industry (ABPI) has released a new position paper making a number of recommendations for the regulation of biosimilar products, including treatment change rights for patients, substitution guidelines and that biosimilar undergo a full health technology assessment process.

(Pharmalot) Roche is feeling increasing amounts of public disapproval over its decision not to publish its clinical trials data on Tamiflu, with much of that heat coming from the British Medical Journal, who has also called for a boycott of the manufacturer.

(Outsourcing Pharma) Natalie Morrison asks, is risk-based monitoring of clinical trials a good idea, or is it simply too much to ask of regulators?

(TGA) Australia is out with new standards for sunscreen. Regulators run down the basic for consumers on this page. (For industry) (The guidelines)

Essential Reading

(Bloomberg) Insider trading has become an increasing problem for healthcare companies in recent years. This Bloomberg article takes a look at some of the most infamous cases, including the case of an FDA chemist and a clinical trials specialist.

(EurekaAlert) Nearly all children born in the US each year are subject to screening using a small sample of blood. The screening tests for diseases, but doesn't always use the entire amount of blood collected. Researchers say that this should be used for research purposes in biomedical studies, but its use has been bogged down under litigation and ethical concerns over privacy. What should be done?

(WSJ) AEDs are life-saving devices if put into the rights hands at the right time. The problem: One the devices are deployed, they are often neglected or forgotten about until someone needs to obtain one. One solution being floated by Philadelphia researchers is a crowd-sourced map of AEDs that can be deployed on a smartphone application.

(Nutra-Ingredients USA) As big pharma discovers the profit associated with the supplement industry, they are likely to bring with them a focus on quality, reports Nutra-Ingredients USA.

(Scientific American) Can devices be used to track outbreaks within a hospital? Yes-and surprisingly easily, explains Scientific American.

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