Regulatory Focus™ > News Articles > Regulatory Reconnaissance (16 November)

Regulatory Reconnaissance (16 November)

Posted 16 November 2012 | By Alexander Gaffney, RAC

Regulatory Reconnaissance is your daily news recap for the regulatory news and intelligence space. Top stories today include: The US Food and Drug Administration's (FDA) Margaret Hamburg appears before a Senate health committee to explain her agency's role in the meningitis outbreak, a new drug-eluting stent gains approval from FDA, new IVD regulations in the works in India, an important upcoming clinical trials data transparency workshop in the EU, and new regulatory oversight in Australia.

United States

(Reuters) Pharmaceutical giants J&J, Merck and Eli Lilly are reportedly joining forces to create a single database to streamline their clinical trials paperwork and administration. The move, reports Reuters, would involve as many as 100,000 investigators around the world.

(Senate) FDA Commissioner Margaret Hamburg testified before the Senate Health, Education, Labor and Pensions (HELP) Committee yesterday-the second day of testimony in a row for Hamburg. She endured several rounds of testy exchange with the Senators, who, like House legislators, demanded answers about the definition of compounders versus traditional manufacturers. Hamburg rebuffed their calls, saying she had been advised not to give a definition in light of an ongoing criminal investigation into the New England Compounding Center. Hamburg's testimony is here. (The Guardian)

(Reuters) Reuters reports legislators promised to change the way compounding pharmacies are regulated. At least one senator, Sen. Alexander (R-TN), suggested a model under which FDA would oversee state regulators, which would be charged with inspecting the compounding facilities.

(Boston Herald) The compounding industry's top lobbying official says his industry is not in favor of new regulations, arguing that sufficient regulation already exists-it just wasn't used in this particular case.

(FDA) Regulators have approved the US' first drug-eluting stent to treat peripheral arterial disease (PAD), a buildup of plaque in the arteries that can cause the hardening or narrowing of arteries. The drug, Zilver PTX Stent, is manufactured by Cook Inc.

(House) Rep. Ed Markey (D-MA) and other Democratic lawmakers have called on the Government Accountability Office (GAO) to investigate the link between group purchasing organizations (GPOs) and drug shortages. Market et al contend that GPOs exert too much market influence, bullying some products out of the market entirely and exacerbating shortages, therefore leading to riskier purchases (such as compounding).

(House) The Energy and Commerce Committee remains annoyed that FDA and Hamburg have not yet passed along documents they requested nearly two months ago. Some members of the committee suggested during Wednesday's hearing that they are considering issuing a subpoena to FDA for documentation regarding the meningitis outbreak and FDA's response to it.

(Expert Recall) What trends did FDA exhibit in conducting recalls in the third quarter of 2012? Expert Recall has its quarterly run-down of the numbers, and they show pharmaceutical recalls to be up sharply.

(Pink Sheet Daily) GlaxoSmithKline's Q-Pan H5N1 vaccine won support in an FDA advisory committee panel this week. Martin Berman-Gorvine reports that had a lot to do with the Biological Products Advisory Committee's concern about the possibility of a bird flu pandemic.

(Pharma Times) The Biological Products Advisory Committee didn't lend as much support to Dynavax' hepatitis B vaccine Heplisav, which panelists said had failed to show sufficient data to support the vaccine's safety profile.

(PCSBI) The President's Bioethics Commission has posted a new study guide regarding its investigation of experiments conducted by the US Public Health Service in 1940 in Guatemala. Those experiments purposefully subjected Guatemalans to STDs, and is one of the most infamous failures of ethics in clinical studies in US history. The commission's goal: Get the case study taught in more schools.

(FDA) Regulatory science is the big phrase around FDA these days, and the agency is on a prolonged kick to make the public more familiar with the term. Its latest: a video explaining the term and why it's good for consumers, featuring Margaret Hamburg.

(FDA) The Neurological Devices Panel of the Medical Devices Advisory Committee will meet on 10 December to evaluate CoAxia's FloControl Catheter.

(In Vivo) Pfizer's Viagra may have lost exclusivity on 6 November 2012, but In Vivo notes that indication only covered the drug's pulmonary arterial hypertension (PAH). The drug's more famous effects are covered under a use patent until 2020.

(Pharmalot) So-called 'pay-for-delay' agreements continue to be litigated in the court system-usually by the Federal Trade Commission (FTC), which thinks they're anti-competitive-but now 31 states have put their weight behind an amicus curiae ("Friend of the court") brief to say that the agreements should be reviewed by the Supreme Court of the US and banned. The states have ample reasons to believe so: Medicaid plans administered and paid for in part by the states aim to keep costs down by prescribing as many generic drug products as possible. Fewer or delayed generics means higher costs.

(CPR Blog) As the think tank Center for Progressive Reform-a pro-regulatory, progressive-leaning think tank-remains us, the Office of Information and Regulatory Affairs (OIRA) remains without a permanent leader after the departure of Cass Sunstein. What qualities should the next leader have?

(RPM Report) Michael McCaughan reports that sales for two drugs sold by, respectively, Amgen and GSK have seen their sales rise dramatically after Risk Evaluation and Mitigation Strategies plans imposed on them were relaxed. Says McCaughan:  "The change underscores the case for a different approach to REMS in oncology, and may point the way forward for broader use of the new tools in a less intrusive way."


(EMA) European regulators are preparing for a big workshop on clinical trials data and transparency, and have been aggressively advertising it on social media channels. The meeting will discuss the agency's plan to publish all clinical trial data and allow researchers to access full data sets. Registration is closed, but the meeting will be live-streamed online.

(EMA) EMA announced it has finalized a review into the supply chain for promatine-containing medical products, finding that it remains safe in relation to historical levels. Promatine is derived from Roe and Wild Salmon, and used to counteract the anticoagulant effects of heparin, particularly when treating heparin overdoses. Because it is derived from animals from a particular region, the batch consistency was a concern for regulators.

(EMA) EU regulators have approved the first vaccine for meningitis B, Bexsero, manufactured by Swiss manufacturer Novartis.

(PharmaBiz) India's Drug Controller General is planning to develop and issue guidance on IVD-based devices in the hopes of bringing uniformity to standards used by the sector, reports PharmaBiz. Also being considered are manufacturing licenses and changes to import licenses.

(PharmaBiz) India's Union Health Ministry will not be granting approvals or renewals for branded generic medicines sold in India, but they will do so for ones intended for export, reports PharmaBiz.

(PharmaBiz) India's Central Drugs Standard Control Organization (CDSCO), the drug regulatory authority for the country, has called upon companies to conduct more clinical research aimed at meeting the needs to indigenous populations in the country, which it claims are under-served.

(ENVI) Missed the hearing of EU Health Commissioner-designate Tonio Borg? Documents and a video from that hearing are now online for viewing.

(TGA) Australian regulators will have their agency reforms guided by a new advisory council appointed by the Australian Government.

(Fierce Vaccines) A Meningitis A vaccine, MenAfriVac, has been found by the World Health Organization (WHO) to be safe for use up to four days after being removed from cold storage. The finding makes it considerably easier to deploy the vaccines into areas where cold-chain storage is unavailable.

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