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New fee structure proposed by FDA might lead to more talk

Ever since 1992, when US lawmakers passed the Prescription Drug User Fee Act (PDUFA) to accelerate review of new drugs by the US Food and Drug Administration, industry money has had an increasingly important role in fueling the regulatory agency. In the program’s first year, drug companies paid less than $9 million total to the FDA through the initiative. But in the past two decades the amount has ballooned; this year, the agency anticipates receiving at least $619 million in user fees, composing roughly 65% of its budget for overseeing human drugs.  Read more

Federal court raises the bar for overturning patents based on omissions in applications

Federal court raises the bar for overturning patents based on omissions in applications

By Charlotte Schubert A US federal appeals court ruling will make it harder for patent holders to lose their intellectual property protection because of charges—often based on small errors or omissions in patent applications—that they engaged in misconduct by misleading or deceiving the patent office. Now, except in egregious cases, such legal challenges can only succeed if the missing information would have affected whether the patent was issued in the first place. The ruling, issued by the US Court of Appeals for the Federal Circuit in Washington, DC in late May, pivoted around a patent for the design of disposable  … Read more

New organization pledges scientific expertise for viral outbreaks

New organization pledges scientific expertise for viral outbreaks

By Adam Mann WASHINGTON, DC — The next time a viral outbreak like H1N1 influenza or the SARS virus threatens the world, Robert Gallo wants the scientific community to be ready. To make that happen, last month Gallo launched the Global Virus Network (GVN), an international group of leading virologists and medical researchers tasked with providing scientific expertise to government agencies in the face of emerging infectious viral agents. “An independent voice of medical laboratory scientists would be a great addition to the surveillance world,” says Gallo, who co-discovered the HIV retrovirus in 1984 and is currently director of the  … Read more

France promotes research into rare diseases with new five-year plan

France promotes research into rare diseases with new five-year plan

By Barbara Casassus PARIS — On 28 February, International Rare Disease Day, the French government finally unveiled a four-year plan to bolster research and treatment into this group of ailments, which include sickle anemia and amyotrophic lateral sclerosis. The plan, which spans from this year to 2014, aims to improve the quality of care for people with rare diseases, bolster research and expand European and international cooperation in this area. It is a continuation of France’s first National Plan for Rare Diseases, which ran from 2005 to 2008 and was claimed to be a world first. (A second iteration of  … Read more

Pooled trials drowning in conflict-of-interest oversights

By Nazlie Latefi Many influential meta-analyses of clinical trial data may be riddled with buried conflicts of interest. According to a report published last month, even when potential conflicts are disclosed in primary studies, they are almost never included in subsequent pooled analyses. The authors of the report say that more transparency is needed in meta-analyses because clinicians and medical organizations regularly rely on such reviews to inform their decisions. Clinical trial reporting guidelines have changed tremendously over the last decade, with strict protocols now in place for disclosing potential financial conflicts. Yet the same guidelines do not exist for  … Read more

Indian officials fret about foreign takeover of drug industry

Indian officials fret about foreign takeover of drug industry

By T V Padma On the face of it, the takeover of six of Indian’s key drug firms by major foreign players in the past four years seems to be routine business. But people within the government and industry watchdogs in India have started to worry. In 2008, Japan’s Daiichi-Sankyo took control of India’s largest drugmaker, Ranbaxy Laboratories, located about 20 miles south of New Delhi. Other Indian firms that have met a similar fate include Dabur Pharma, Shantha Biotech, Piramal Healthcare, Matrix Laboratories and Orchid Chemicals and Pharmaceuticals. Local concern grows out of the fact that these companies are  … Read more

Q&A: Exit interview with outgoing NIGMS director Jeremy Berg

Q&A: Exit interview with outgoing NIGMS director Jeremy Berg

By Michelle Pflumm In December, Jeremy Berg announced plans to step down from the helm of the US National Institute of General and Medical Sciences (NIGMS), the $2 billion branch of the National Institutes of Health charged with funding basic research related to diverse biological processes and diseases. In his seven years as NIGMS director, Berg spearheaded the institute’s first formal strategic plan, led efforts to increase workforce diversity and kick-started an open conversation with the scientific community about funding and peer review. In recognition of his many accomplishments, last year Berg was elected to the US Institute of Medicine  … Read more

FDA transparency initiative moves ahead despite Sharstein’s departure

FDA transparency initiative moves ahead despite Sharstein’s departure

By Charlotte Shubert An initiative to increase transparency at the US Food and Drug Administration (FDA) moved forward on 6 January with the release of a report detailing steps the agency says it is undertaking to make its inner workings more evident to the drug industry. The report, FDA Transparency Initiative: Improving Transparency to Regulated Industry, includes 19 so-called ‘action items’ for implementation this year, ranging from posting presentations by agency employees online to responding faster to questions from industry. The document also lists five draft proposals—now up for public comment—to further improve transparency. (Click here to continue reading.)  … Read more

Report calls for overhaul of UK’s clinical and health research

By Bea Perks Complex regulation and governance of clinical research in the UK has held back research with no evidence of improved patient safety, concludes a report by the country’s Academy of Medical Sciences (AMS). The AMS was commissioned by the UK government in March 2010 to review the regulation of clinical and health research. The review, released on 10 January, recommends the establishment of an independent Health Research Agency (HRA) to simplify approval processes that currently differ across the UK. The authors also recommend the establishment of a National Research Governance Service within the HRA to accelerate approval of  … Read more

Substance abuse vaccines move forward against a range of addictions

Substance abuse vaccines move forward against a range of addictions

By Kelly Rae Chi Illicit drug use has reached a near-decade high in the US, so it’s perhaps not surprising that public health officials harbor strong hopes for vaccines to treat various addictions. But whereas some experimental vaccines of this sort have shown promise in animal studies and early clinical trials, it seems that some of these shots against addiction—such as immunizations against nicotine—are better positioned to reach the market than others. (Click here to continue reading.) Image: Michael Velardo, Flickr  … Read more