Regulatory Focus™ > News Articles > Regulatory Reconnaissance (10 January 2013)

Regulatory Reconnaissance (10 January 2013)

Posted 10 January 2013 | By Alexander Gaffney, RAC

United States

(Huffington Post)  United Airlines will no longer transport monkeys for use in human testing, further complicating efforts to conduct late-stage pre-clinical research in the US. The move was prompted by pressure from animal rights organization PETA, which has already found success in pressuring a number of other airlines to do the same.

(The Manhattan Institute) The FDA needs to create a "Safe harbor" for off-label drug usage in the wake of the US v. Caronia decision, argue Paul Howard and James Copland. Why? Because medications are already widely prescribed off label, and FDA could stand to rein in "overly broad and unnecessarily opaque regulations," they say.

(Think Progress) - Advocates have long said that medical data, including that from clinical trials, would benefit from being made available "in the cloud"-a term referring to information hosted on remote servers that is available to authorized persons no matter where they are. Federal officials, however, are sounding the alarm about potential security and data privacy issues that might complicate the effort to move to cloud-based storage.

(IOM) - How often should children receive vaccines? Biologics manufacturers should keep a keen eye on the 16 January 2013 release of a report, entitled The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence and Future Studies.

(TogoRun) - What does the new freshman Congress look like for the healthcare sector? This new report digs into each member, including their professional backgrounds.

(MDDI) - Companies need to invest more money into developing FDA-compliant labeling, argues a piece in MDDI. Why?

(Pharmalot) - Patient advocacy group Public Citizen is-as always-criticizing government regulators over perceived failings. Its attention is now turned to the US Department of Health and Human Services, which oversees clinical trials conducted by the National Institutes of Health. The group alleges that some pediatric trials should never have been allowed to proceed in light of its risks and lack of proper oversight.

(The Pink Sheet) - How could legislators cut costs? One rare disease advocacy group is saying it expects them to start looking at the sky-high prices of some orphan therapies, which are largely paid for by government groups such as Medicaid and Medicare.


(The Guardian) - Could the UK be thinking about leaving the EU? US officials seem to at least be entertaining the possibility that their English-speaking counterparts might do so, and are warning them not to, saying the consequences could be dire. At issue for regulators: The UK is an integral part of the European Medicines Agency (EMA), which is headquartered in London. A withdrawal from the EU might lead to a split from EMA, among other consequences.

(PharmaBiz) - In India, healthcare product regulations aren't the only ones that might keep your product from getting to market. In this case, at least 25 companies, including some pharmaceutical ones, will see their manufacturing operations shut down in response to allegations that they were operating illegally and polluting kilometers of water.

(Eye on Pharma) Drug giant Merck took an unusual step recently, reporting  to the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee that a long-term study of one of its products, Tredaptive, was less safe and no more effective than existing statin therapies.

(PharmaBiz) - India has launched a new biological vigilance program dubbed the Biovigilance Programme of India (BvPI) in conjunction with the Indian Pharmacopoeia Commission.

Essential Reading

(PWC) - A new research piece by PriceWaterhouseCooper says that the presence of regulatory guidance is among the top three most influential factors in formulary decisions by private insurers. No, not FDA or EMA guidance-health economics guidance issued by organizations like the National Institutes for Health and Clinical Excellence (NICE).

(PharmPro) - Canadian researchers have found that a significant number of drug trials published in medical journals-even prestigious ones-are guilty of spinning and bias. Their study looked at 164 breast cancer trials, and found that studies that didn't find a significant benefit tended to dig into results and focus on minor, potentially insignificant findings.

(Cutting Edge Info) - Regulatory outsourcing in the pharmaceutical sector increased 5% since 2010 and now makes up an average of 10% of top companies' overall regulatory budgets, a new report says.

(NBC) - New technology being tested by TruTag Technologies promises to be able to allow drugs to be tracked on a per-pill basis, benefiting from a special silica dust coating that could be scanned. The company says its technology could facilitate product recalls and enhance patient safety.

(The Hill) - Countries are ill-prepared to deal with the rise of antibiotic-resistant superbugs which are threatening to outpace the development of new therapies, the World Economic Forum charges in a new report. That finding could eventually lead to new global action on ways to both slow the rising tide of drug-resistant bacteria and speed the development of new antibiotics.

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