France urges Mali to step up talks with rebels

PARIS (AP) — France‘s president called Thursday for stepped-up talks between Mali’s government and any leaders from its breakaway north “who reject terrorism,” even as African nations geared up for a possible military operation against Islamic extremists there.

President Francois Hollande‘s comments suggested a growing openness to dialogue with the extremists, but he remained committed to supporting the military planning effort.

Northern Mali fell to Islamic extremists in April, after coup leaders toppled the government in Bamako, Mali‘s capital. Fearing that northern Mali could become the latest hotbed of terrorism, France has been a driving force in international efforts to bolster Mali’s army to drive the Islamists from power.

Hollande spoke with interim Mali President Dioncounda Traore by phone on Thursday, partly to detail European efforts to help strengthen Mali’s army.

In recent days, representatives from the most moderate of three al-Qaida-linked groups that control northern Mali have been meeting with Burkina Faso‘s president, appointed as a mediator.

“France reiterates its wish that political dialogue will intensify between Malian authorities and representatives of northern populations who reject terrorism,” Hollande’s office said in a statement. “The acceleration of this dialogue must accompany the progress in African military-planning efforts.”

Earlier this week, the African Union approved a plan that calls for 3,300 African troops to be deployed in order to win back Mali’s north. European countries including France and Germany have expressed a willingness to provide military trainers and logistics support, but have stopped short of committing combat troops.

France, like many European countries, fears that the arid, northern Sahel region of Mali could become a breeding ground for terrorism, where al-Qaida and its allies could plot hostage-takings and attacks in Europe or beyond.

France has millions of people whose families hail from former French colonies in north and west Africa. Authorities have long been concerned that French-born militants could travel abroad for terrorism training and return home later to possibly carry out attacks.

French authorities are already investigating two French citizens who were arrested in Mali and neighboring Niger and are suspected of seeking to join up with the al-Qaida-linked extremists, a judicial official told The Associated Press.

Ibrahim Ouattara, a 24-year-old native of the northern Paris suburb of Aubervilliers who has dual French and Malian nationality, was arrested inside Mali this month and remains in custody there, the official said.

Separately, a 27-year-old Frenchman was arrested in August in Niger and has since been handed over to authorities in France, the official said, speaking on condition of anonymity because she was not authorized to discuss terrorism cases publicly.

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Android 4.2 For Nexus 7, Galaxy Nexus Now Available

When Google’s Nexus 10 tablet was unveiled recently, it was running Android 4.2, a new version which adds several features. That version is coming to your Nexus 7 or Galaxy Nexus device as well. Here’s what Android 4.2 brings, where to get it, and which Nexus devices are missing out.

​New features in Android 4.2

Mashable’s Christina Warren has the scoop on what Android 4.2′s bringing. Flashy additions include Daydream, a sort of screensaver for your smartphone or tablet, and Photo Sphere, a new way to take panoramic photographs that capture the whole world around you. Right now you can only see Photo Sphere images on Google+ or in Google Maps, but according to David Ruddock of the Android Police blog Google has made it so “Anyone could, in theory, build a Photo Sphere viewer.”

Less immediately noticeable improvements include a Swype-style gesture keyboard, where you don’t need to type individual letters, and a feature that lets multiple people share the same Android tablet without their apps and things getting in each others’ way. You’ll also be able to mirror your Android device’s screen on your HDTV, Apple AirPlay style, although instead of an Apple TV box you’ll need a third-party wireless display adapter.

​Who’s getting the upgrade now

Nexus 7 owners are already beginning to receive the Android 4.2 upgrade over the air. Your tablet will automatically check for it every so often, but if you want to hurry it along you can go to Settings -> About tablet -> System updates, and tell it to check again. You can also download it from Google and manually install it using Liam Spradlin’s instructions, although this is not recommended unless you’re an experienced Android hacker and are using the Wi-Fi version of the Nexus 7.

Galaxy Nexus owners who bought their phones from a wireless carrier have had to wait an unusually long time for upgrades, as long as several months after a new Android version’s announced. If you bought your Galaxy Nexus phone from a wireless carrier, an upgrade probably won’t be available anytime soon. People who purchased their Galaxy Nexus from the Google Play store are reporting that they are getting the upgrade, though, and Spradlin again has instructions for how to install manually if you are using a Galaxy Nexus bought from the Google Play store.​

Who’s being left out

While announcing that Android 4.2′s programming code was being released to the Android Open-Source Project, Google rep Jean-Baptiste Queru said “There is no support for 4.2 on Nexus S and Xoom.” The Nexus S was a Nexus smartphone released about two years ago, in late 2010, while the Motorola Xoom was the first tablet released (in early 2011) running the Honeycomb version of Android. The Xoom was not an official Nexus device, but was also made in close partnership with Google, and showcased the latest Android software.

Both devices received upgrades to Android 4.1, the first Jelly Bean version. It looks like this is where the upgrade train ends for them, though, after almost two years of support. In contrast, Apple’s iPhone 3GS, released in mid-2009, just recently received an upgrade to the latest version of iOS.

Jared Spurbeck is an open-source software enthusiast, who uses an Android phone and an Ubuntu laptop PC. He has been writing about technology and electronics since 2008.

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NBC names new “Today” show chiefs

(Reuters) – Comcast‘s NBC has appointed two executives to take charge of the “Today” show, a day after the television network announced that longtime producer Jim Bell would be leaving to take a larger role in the sports division.

Don Nash, a broadcast producer who has worked on NBC’s morning show for 23 years, will become the executive producer, reporting to Alexandra Wallace, who has been named executive in charge of the show.

The reshuffling is part of NBC efforts to revive the “Today” show, which has been in a back-and-forth ratings war with ABC’s “Good Morning America” ever since ABC snapped NBC’s 16-year unbeaten streak earlier in the year.

“Today” is one of NBC’s most profitable TV shows, generating $ 485 million in ad revenues in 2011, up 6.6 percent from 2010, according to Kantar Media, which provides data to advertisers. Rival “Good Morning America” took in $ 299 million last year.

NBC said on Tuesday that former executive producer Bell would be leaving the morning show to become a full-time executive producer of the Olympics. The network has a contract to broadcast the Olympics in the United States for the next four games in Russia, Brazil, South Korea and an unnamed host city in 2020.

Bell, who has headed the show since 2005, was blamed this year for the controversial firing of Ann Curry as anchor alongside Matt Lauer.

Reuters had previously reported in August that Bell was in line for a kind of uber-producing sports role like the one Dick Ebersol – NBC’s longtime Olympics executive producer and former sports chief who served as a mentor to Bell – played for the network.

(Reporting By Liana B. Baker; Editing by Tim Dobbyn)

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Chinese Communist Party to unveil new leadership

BEIJING (Reuters) – China‘s ruling Communist Party unveils a new leadership line-up on Thursday to steer the world’s second-largest economy for the next five years, with Vice President Xi Jinping taking over from outgoing President Hu Jintao as party chief.

The new members of the Politburo Standing Committee – the innermost circle of power in China’s authoritarian government – will emerge around 0300 GMT (10 p.m. EDT on Wednesday) after a closely controlled vote by the party’s new 205-member central committee, which was installed at the end of a five-yearly party congress on Wednesday.

Only Xi and Vice Premier Li Keqiang are certain to be on the new standing committee. Xi will take over Hu’s state position in March at the annual meeting of parliament, when Li will succeed Premier Wen Jiabao.

The committee is expected to be reduced to seven seats from nine to make consensus-building easier.

The other preferred candidates, according to sources close to the party leadership, are North Korean-trained economist Zhang Dejiang, financial guru Wang Qishan, minister of the party’s organization department Li Yuanchao, Tianjin’s party boss Zhang Gaoli, and the conservative Liu Yunshan, who has kept domestic media on a tight leash.

The list of the conservative-leaning preferred candidates was drawn up by Xi, Hu and Hu’s predecessor, Jiang Zemin, the sources said.

Wang, currently vice-premier in charge of economic affairs, is popular with foreign investors but seems set to lead the fight against corruption, having been elected to the party’s main anti-graft body on Wednesday.

Guangdong’s reform-minded party boss Wang Yang, Shanghai party boss Yu Zhengsheng and Liu Yandong, the lone woman, are dark horse candidates.

All eight of these people were on the list for the new central committee, the largest of the party’s top decision-making bodies. Exclusion from that committee means a person cannot progress to the Politburo or the standing committee.

The new leadership will emerge on Thursday morning to “meet the press” in a room in the cavernous, Soviet-style Great Hall of the People, which has been decked out in enormous red flags.

Intense secrecy has also surrounded who and how many will be promoted to the Politburo, a council of 20-odd members, and the all-powerful standing committee.

The composition of the two elite bodies could give clues to China’s political and economic direction, especially if they end up being dominated by conservatives.

Advocates of reform are pressing Xi to cut back the privileges of state-owned firms, make it easier for rural migrants to settle in cities, fix a fiscal system that encourages local governments to live off land expropriations and, above all, tether the powers of a state that they say risks suffocating growth and fanning discontent.

With growing public anger and unrest over everything from corruption to environmental degradation, there may also be cautious efforts to answer calls for more political reform, though nobody seriously expects a move towards full democracy.

The party could introduce experimental measures to broaden inner-party democracy – in other words, encouraging greater debate within the party – but stability remains a top concern and one-party rule will be safeguarded.

Another decision to watch will be chairman of the Central Military Commission. Hu may or may not choose to stay on in that post for a year or two, as did his predecessor, Jiang.

Which standing committee member gets which portfolio depends, in this hierarchical and top-down state, on the order members appear for the first time together on stage.

While the first person out will be Xi, signifying his position as party leader and president-designate, the party’s second-ranked position is head of the largely rubber stamp parliament, leaving the premier in third place.

But portfolios of the second and third-ranked leaders are likely to be reversed, giving Li higher status, sources have said.

Fourth position has historically been occupied by the head of the ceremonial advisory body to parliament, while fifth could be either vice president or propaganda tsar, sixth the executive vice premier and seventh the person in charge of fighting graft.

One position almost certain to go is that held by Zhou Yongkang, the domestic security tsar, reflecting fears the role has become too powerful.

(Additional reporting by Benjamin Kang Lim; Editing by Nick Macfie and Raju Gopalakrishnan)

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FTC chief: Kids’ Internet privacy rules done by year’s end

WASHINGTON (Reuters) – Regulators will likely finish a long-awaited update to rules protecting children’s online privacy by the end of the year, the head of the Federal Trade Commission said on Tuesday.

The original rules were developed when most computers were large beige boxes sitting under office desks instead of smartphones slung into backpacks and permeating most aspects of daily life.

FTC Chairman Jon Leibowitz said the agency was moving forward on two issues: self-regulatory “do not track” guidance, and regulations to update the Children’s Online Privacy Protection Act, or COPPA.

The law requires that website and online service operators obtain verifiable consent from parents before collecting information about children.

Leibowitz, who is thought keen to leave the agency within months, said he was more confident of finishing an update of COPPA’s rules, which were written following the 1998 legislation.

Under revised rules, the FTC would make websites, mobile apps and data brokers all responsible for getting parental consent before collecting data about children aged 12 and younger. Currently it is unclear who has the responsibility.

Data brokers buy and sell consumer data.

Speaking at the Wall Street Journal’s annual CEO Conference in Washington, Leibowitz said the process would most likely be done by the end of the year.

“We are looking at all the comments that came in and weighing how to tweak the regulation,” he said.

Leibowitz was slightly less optimistic about the fate of “do not track,” an effort to allow Internet users to tell companies they did not want to be tracked online.

Some large technology companies, like Microsoft and Google, have agreed to let consumers opt out of being tracked, but advertisers have pushed back hard.

“We’re still making forward progress,” Leibowitz said when asked if the efforts would be done by the end of the year. “We continue to be optimistic. It’s not a certainty though.”

(Reporting By Diane Bartz; Editing by Ros Krasny and Kenneth Barry)

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Man who accused Elmo puppeteer of teen sex recants

NEW YORK (AP) — A man who accused Elmo puppeteer Kevin Clash of having sex with him when he was a teenage boy has recanted his story.

In a quick turnabout, the man on Tuesday described his sexual relationship with Clash as adult and consensual.

Clash responded with a statement of his own, saying he is “relieved that this painful allegation has been put to rest.” He had no further comment.

The man, who has not identified himself, released his statement through the Harrisburg, Pa., law firm Andreozzi & Associates.

Sesame Workshop, which produces “Sesame Street” in New York, soon followed by saying, “We are happy that Kevin can move on from this unfortunate episode.”

The whirlwind episode began Monday morning, when Sesame Workshop startled the world by announcing that Clash had taken a leave of absence from “Sesame Street” in the wake of allegations that he had had a relationship with a 16-year-old.

Clash, a 52-year-old divorced father of a grown daughter, swiftly denied the charges of his accuser, who is in his early 20s. In that statement Clash acknowledged that he is gay but said the relationship had been between two consenting adults.

Though it remained unclear where the relationship took place, sex with a person under 17 is a felony in New York if the perpetrator is at least 21.

Sesame Workshop, which said it was first contacted by the accuser in June, had launched an investigation that included meeting with the accuser twice and meeting with Clash. Its investigation found the charge of underage conduct to be unsubstantiated.

Clash said on Monday he would take a break from Sesame Workshop “to deal with this false and defamatory allegation.”

Neither Clash nor Sesame Workshop indicated on Tuesday when he might return to the show, on which he has performed as Elmo since 1984.

Elmo had previously been a marginal character, but Clash, supplying the fuzzy red puppet with a high-pitched voice and a carefree, child-like personality, launched the character into major stardom. Elmo soon rivaled Big Bird as the face of “Sesame Street.”

Though usually behind the scenes, Clash meanwhile achieved his own measure of fame. In 2006, he published an autobiography, “My Life as a Furry Red Monster,” and he was the subject of the 2011 documentary “Being Elmo: A Puppeteer’s Journey.”

He has won 23 daytime Emmy awards and one prime-time Emmy.

___

Online:

http://www.sesamestreet.org

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Hospira says FDA blocks import of Symbiq infusion pump

(Reuters) – The U.S. Food and Drug Administration has prohibited Hospira Inc from importing its Symbiq medication infusion pumps, which are manufactured in Costa Rica, into the United States, the company said Tuesday in a regulatory filing.

Hospira in the filing did not say why the FDA imposed the restriction. A Hospira spokesperson could not be immediately reached.

The company said the FDA’s action does not restrict importation of its other medication management products, and the company does not expect it will have a material impact on its ability to achieve its 2012 financial projections.

In August, Hospira announced it received a warning letter from the FDA over quality problems at the Costa Rica plant where it makes most of its infusion pumps. Among the issues cited were alarm failures on the company’s Plum brand of infusion pump.

At the time, the company said it was switching alarm components for the Plum pump, which was recalled in February 2011, and expected to complete that process by early 2013.

Hospira on November 7 said it had placed a voluntary hold on shipments of the Symbiq pumps to new U.S. customers. A day later, the FDA notified the company of the import restriction, Hospira said.

Last month, the FDA said some Symbiq models were recalled due to software issues after Hospira received reports from customers of touch screens that were not responsive, delaying therapy.

The Lake Forest, Illinois-based maker of medical devices and injectable specialty drugs said it will support the repair and replacement of Symbiq pumps to existing customers.

Hospira has been working for several years to resolve manufacturing issues at some of its plants. In February, it resumed production of injectable drugs at its Rocky Mount, North Carolina, plant after a maintenance shutdown. Manufacturing problems at that plant had let to shortages of anesthesia and other drugs for its customers.

Hospira shares were little changed in after-hours trading from Tuesday’s close of $ 29.60 on the New York Stock Exchange.

(Reporting by Susan Kelly in Chicago; Editing by Leslie Adler and Phil Berlowitz)

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General investigated for emails to Petraeus friend

PERTH, Australia (AP) — In a new twist to the Gen. David Petraeus sex scandal, the Pentagon said Tuesday that the top American commander in Afghanistan, Gen. John Allen, is under investigation for alleged “inappropriate communications” with a woman who is said to have received threatening emails from Paula Broadwell, the woman with whom Petraeus had an extramarital affair.

Defense Secretary Leon Panetta said in a written statement issued to reporters aboard his aircraft, en route from Honolulu to Perth, Australia, that the FBI referred the matter to the Pentagon on Sunday.

Panetta said that he ordered a Pentagon investigation of Allen on Monday.

A senior defense official traveling with Panetta said Allen’s communications were with Jill Kelley, who has been described as an unpaid social liaison at MacDill Air Force Base, Fla., which is headquarters to the U.S. Central Command. She is not a U.S. government employee.

Kelley is said to have received threatening emails from Broadwell, who is Petraeus’ biographer and who had an extramarital affair with Petraeus that reportedly began after he became CIA director in September 2011.

Petraeus resigned as CIA director on Friday.

Allen, a four-star Marine general, succeeded Petraeus as the top American commander in Afghanistan in July 2011.

The senior official, who discussed the matter only on condition of anonymity because it is under investigation, said Panetta believed it was prudent to launch a Pentagon investigation, although the official would not explain the nature of Allen’s problematic communications.

The official said 20,000 to 30,000 pages of emails and other documents from Allen’s communications with Kelley between 2010 and 2012 are under review. He would not say whether they involved sexual matters or whether they are thought to include unauthorized disclosures of classified information. He said he did not know whether Petraeus is mentioned in the emails.

“Gen. Allen disputes that he has engaged in any wrongdoing in this matter,” the official said. He said Allen currently is in Washington.

Panetta said that while the matter is being investigated by the Defense Department Inspector General, Allen will remain in his post as commander of the International Security Assistance Force, based in Kabul. He praised Allen as having been instrumental in making progress in the war.

The FBI’s decision to refer the Allen matter to the Pentagon rather than keep it itself, combined with Panetta’s decision to allow Allen to continue as Afghanistan commander without a suspension, suggested strongly that officials viewed whatever happened as a possible infraction of military rules rather than a violation of federal criminal law.

Allen was Deputy Commander of Central Command, based in Tampa, prior to taking over in Afghanistan. He also is a veteran of the Iraq war.

In the meantime, Panetta said, Allen’s nomination to be the next commander of U.S. European Command and the commander of NATO forces in Europe has been put on hold “until the relevant facts are determined.” He had been expected to take that new post in early 2013, if confirmed by the Senate, as had been widely expected.

Panetta said President Barack Obama was consulted and agreed that Allen’s nomination should be put on hold. Allen was to testify at his confirmation hearing before the Senate Armed Services Committee on Thursday. Panetta said he asked committee leaders to delay that hearing.

NATO officials had no comment about the delay in Allen’s appointment.

“We have seen Secretary Panetta‘s statement,” NATO spokeswoman Carmen Romero said in Brussels. “It is a U.S. investigation.”

Panetta also said he wants the Senate Armed Services Committee to act promptly on Obama’s nomination of Gen. Joseph Dunford to succeed Allen as commander in Afghanistan. That nomination was made several weeks ago. Dunford’s hearing is also scheduled for Thursday.

___

Associated Press writer Slobodan Lekic in Kabul, Afghanistan, contributed to this report.

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Engineers of the Future Design Star Trek-Inspired Tricorder Device

A group of college and high school students has designed a Star Trek-inspired sensing device that can beam environmental data to a smart phone. The team developed their project during a summer internship program run by the Wright Brothers Institute and the Air Force Research Laboratory. and shared their results at this fall’s World Maker Faire in New York City–a showcase of DIY ingenuity. The Summer at the Edge program gives student teams ten weeks to work on science and engineering projects. The tricorder device is the team’s response to a challenge from the U.S. Environmental Protection Agency: “Is there an effective way to integrate external sensors with smart phones and can we globalize this information?” Applications could range from data collection for research to educational hands-on activities to disaster-zone assessment. The description reminded the students of a Star Trek gadget. In the sci-fi television series, the tricorder is a hand-held device used to diagnose illness, scout alien planets and more. Several real-life tricorders have been developed or proposed and the 15-member student team decided to take a crack at designing their own. The device itself looks like a clear brick filled with computer parts and batteries. It is built around an open-source computing platform called an Arduino microcontroller and transmits data via Bluetooth. An environmental sensing pod connects to the controller and collects measurements on variables like temperature, wind speed and radiation levels. Users can view data collection in real time via Google maps or an interactive graph and monitor changes and search for patterns. The tricorder’s modular design lets the team swap functionalities while still using the same Arduino controller and software. To demonstrate, the team built an additional pod equipped with an infrared beam and motion detector–a security sensor. Along the way, the team faced some challenges. Getting the sensors and the tablet to talk to each other involved a lot of troubleshooting. “We were having a lot of trouble with the Bluetooth communications,” says Lujack Prater, a junior studying electrical engineering at Ohio State University, who worked on the software design. “It was a few days that we didn’t get it. We were working on it and working on it.” Then a breakthrough: “It was really exciting–I remember the first time we started getting data streaming to the tablet,” says Grace Crumrine, part of the hardware sub-team and a sophomore in electrical engineering at Ohio State University. “But it was completely corrupt and didn’t mean anything.” The team needed to iron out software glitches and calibrate their sensors. Crumrine explains that the wind sensor was just “spitting out analogue values and we didn’t know what they meant.” So they took the sensor for a ride. While her teammate drove, Crumrine stuck the sensor out the car window. They were able to determine which values corresponded to specific speeds by rolling down the road at five, then 10 miles per hour and so on. The EPA was impressed, says Rob Williams, head of the internship program and research director of the Air Force Research Laboratory‘s Discovery Lab. “The tricorder was one of the more ambitious research projects,” he adds. “I think it validated the model that we’ve been an advocate of–bringing together motivated students and giving them the opportunity to have fun learning while doing projects that have potential.” Other notable projects include a tablet-based virtual walkthrough of medical techniques to train physicians and a device that can detect the brain’s electrical signals to give quadriplegics control over robots. What’s the next step for Project Tricorder? Williams would like to find teachers and students around the country who want to use the team’s design. He says middle school students could use the device to see how technology can help protect the environment. The military could use it to download information to virtual command centers and guide decision-making during a search and rescue based on current conditions. The device’s multi-functionality and connection to a smart phone would be key advantage. Sensor pods could even be installed in remote or dangerous locations and still report via Bluetooth.

Lujack Prater and Grace Crumrine with their team's device at the World Maker Faire. Credit: Grace Crumrine

Both Prater and Crumrine say the program is hard work. Prater spent the first two weeks learning how to code and program Android devices. “You get so involved in the project that you forget what you are doing,” says Crumrine. “Then when you present it to people you see their face with all the excitement and astonishment. It is worth it.”

Follow Scientific American on Twitter @SciAm and @SciamBlogs. Visit ScientificAmerican.com for the latest in science, health and technology news.
© 2012 ScientificAmerican.com. All rights reserved.

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Meningitis-linked U.S. firm not a drug maker in 2003 -report

WASHINGTON (Reuters) – Government health regulators in 2003 told the pharmacy now at the center of a deadly meningitis outbreak that its drug compounding activities did not constitute a manufacturing operation that would merit strict federal safety standards, a congressional report said on Monday.

The report by the Republican staff of a U.S. House of Representatives committee, said the Food and Drug Administration and Massachusetts state officials decided to leave oversight of the New England Compounding Center to a state pharmacy board, despite evidence of health problems linked to two drugs in 2002.

One of the drugs was methylprednisolone acetate, the same steroid treatment health officials have identified as the source of a current U.S. fungal meningitis outbreak that the U.S. Centers for Disease Control and Prevention says has grown to 438 cases, including 32 deaths, in 19 states.

Where to draw the line between drug manufacturing and drug compounding is a central question for U.S. lawmakers, who will hold separate House and Senate hearings this week as part of two investigations to determine whether the FDA should be given stronger authority to regulate compounding operations.

The House Energy and Commerce Committee, which produced the Republican report, is scheduled to hold its hearing on Wednesday with testimony expected from FDA Commissioner Margaret Hamburg, interim Massachusetts health commissioner Lauren Smith and NECC co-owner Barry Cadden, who has been subpoenaed to appear.

A separate hearing before the Senate Health, Education, Labor and Pensions Committee is scheduled for Thursday with a similar roster of witnesses expected.

A handful of Democrats have called for new legislation to strengthen federal oversight of the compounding industry, in which pharmacists traditionally alter or recombine drugs to meet the special needs of specific patients.

Drug compounding has evolved in recent decades to include large-scale production that some experts view as drug manufacturing that should be subject to FDA regulation.

But the compounding industry is currently overseen mainly by state authorities that are often ill-equipped for the job.

Up to now, compounding pharmacies have waged long legal and lobbying battles to stave off federal regulation. And some in Congress worry that failure to act before the end of the current lame duck session could postpone legislation in 2013 and risk losing momentum driven by the growing number of cases.

The advocacy group Public Citizen earlier this month called on the Obama administration to launch an independent probe into FDA’s lack of action against NECC. The group alleges that FDA already has the authority it needs, but that agency officials failed to take steps that could have prevented the current outbreak

Responding to a Reuters query about Public Citizen’s claims, the Department of Health and Human Services, which oversees FDA, said the agency has limited powers over compounders and urged Congress to strengthen its authority.

SERIOUS CONSEQUENCES

The House Republican report does not say how health officials determined NECC to be a pharmacy instead of a manufacturer. But the decision came after NECC had doubled its production space and begun pursuing a marketing strategy that called for selling compounded drugs to customers in all 50 states.

“It was decided that ‘current findings supported a compounding role’ and that ‘the state would be in a better position to gain compliance or take regulatory action against NECC as necessary’,” said the report.

The decision came at a February 5, 2003 meeting between FDA and state officials that ended with federal regulators emphasizing the potential for “serious public health consequences” if NECC’s compounding practices, in particular those relating to sterile products, did not improve.

“It is noteworthy that after closing out the inspection … FDA’s primary NECC investigator and her supervisor recommended that the ‘firm be prohibited from manufacturing until they can demonstrate ability to make product reproducibly and dependably’.”

Cadden was informed soon after the meeting that FDA did not consider his company to be a manufacturer. On February 26, 2003, he responded in writing to an FDA document calling for corrective measures at NECC by saying: “We are not subject to (nor are we voluntarily subjecting ourselves to) current good manufacturing practices as promulgated by FDA, since we are a compounding pharmacy, not a manufacturer.”

The decision to leave oversight largely to state officials also followed an April 2002 encounter between FDA investigators and Cadden in which the report said the NECC executive challenged the FDA’s authority to be at his pharmacy and refused to provide information or records to the federal agency.

But problems continued at NECC, and the FDA finally issued a warning letter in 2006 warning that the company’s compounding operations had begun to resemble manufacturing operations and still posed potential health risks from the compounding of sterile drugs.

“NECC has a long history of very similar, if not identical, underlying misconduct,” said the congressional report.

“Some of the violations observed by regulators as early as 2002 include the company’s failure to maintain adequate safeguards for sterile injectable products — the very issue at the center of the current meningitis outbreak.”

On Monday, FDA said it discovered insects, a flying bird and other unsanitary conditions at NECC’s sister company, Ameridose LLC. [ID:nL1E8MCDDH]

(Reporting by David Morgan; Editing by Michele Gershberg and Tim Dobbyn)

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