uFDA Ends Across-The-Board Ban On Blood Donations From Gay, Bisexual Menr

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  Exactly a year ago this week, the Food and Drug Administration announced that it was going to eventually change its guidance on blood donations that had barred any man who had been intimate with another male at any time in the previous three decades from donating. Today, the FDA finalized that change, which still requires that all male donors abstain from same-sex intimacy for a year before donating.

  Following the outbreak of HIV in the 1980s, the FDA sought to prevent the spread of the virus through blood transfusions by enacting a lifetime deferral for gay and bisexual men — or any male who had been sexually intimate with another man. The agency claims that — between the ban, other restrictions, and improved screening — the rate of HIV transmission through transfusions has dropped from 1 in 2,500 to 1 in 1.47 million.

  Last year, then FDA-chief Margaret Hamburg explained that the change to the blood donation guidance came about as the agency endeavored to update its standards to reflect current technology and the relevant “available scientific evidence…including the results of several recently completed scientific studies and recent epidemiologic data.”

  “The FDA’s responsibility is to maintain a high level of blood product safety for people whose lives depend on it,” said the FDA’s Acting Commissioner Stephen Ostroff in a statement earlier today. “We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply.”

  The one-year deferral treats men who have had sex with men the same as others believed to be at an increased risk for HIV transmission, including recent recipients of blood transfusions and those who have been accidentally exposed to another person’s blood.

  It also meshes more closely with deferral timelines in the U.K. and Australia. The FDA says that when Australia updated its policy to shorten the deferral, it saw no change in the risk to the blood supply.

  “In reviewing our policies to help reduce the risk of HIV transmission through blood products, we rigorously examined several alternative options, including individual risk assessment,” said Peter Marks, M.D., Ph.D., deputy director of the FDA’s Center for Biologics Evaluation and Research. “Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population. We will continue to actively conduct research in this area and further revise our policies as new data emerge.”

  The American Red Cross, the AABB (formerly the American Association of Blood Banks), and America’s Blood Centers have been advocating for the lift on the all-out ban on donations. In a joint statement, the groups say they are pleased with the revised guidance from the FDA.

  “The top priority of the blood banking community is the safety of our volunteer blood donors and the recipients of blood,” reads the statement. “While the final FDA guidance describes a pathway for previously deferred donors to give blood, it will take several months for blood centers to update their computer systems, modify processes and procedures, train staff and implement these extensive changes.”

  There are those who believe that even a one-year ban is too restrictive. For example, a man in a monogamous relationship with another man in need of blood may not be able to donate — or he may have to lie about his sexuality or his connection to the recipient to be eligible to give his blood.

  
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by Chris Morran via Consumerist

uBMW To Pay $40M For Failing To Recall Mini Coopers In A Timely Mannerr

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  Three months after federal regulators opened a probe into whether BMW failed to recall more than 30,000 Mini Cooper cars in a timely fashion after certain models did not meet side impact crash standards, the National Highway Traffic Safety Administration fined the car manufacturer $40 million after finding a series of violations. 

  NHTSA announced on Monday that for the second time in the past three years it has imposed a multi-million fine against BMW for violations of the Motor Vehicle Safety Act and other regulations.

  According to the consent order [PDF], BMW acknowledges it violated requirements to issue a timely recall of vehicles that did not comply with minimum crash protection standards, to notify owners of recalls in a timely fashion, and to provide accurate information about its recalls to NHTSA.

  The order resolves a September investigation into BMW’s failure to initiate a recall within five days of NHTSA finding nearly 30,456 model year 2014 to 2015 Mini Cooper, Cooper S and 2015 John Cooper Works vehicles failed side impact crash tests back in 2014.

  In October 2014, a Mini 2 Door Hardtop Cooper failed a crash test designed to determine whether the vehicle met crash-protection minimums.

  “NHTSA viewed these results as indicating a potential problem and believes BMW should also have been concerned with the compliance of the vehicles,” regulators said in September.

  The company responded that the vehicle was listed with an incorrect weight and would pass the test if conducted at the proper weight rating, but agreed to conduct a recall to correct the incorrect weight rating on the vehicle’s Tire Information Placard and to conduct a voluntary service campaign, short of a recall, to add additional side-impact protection.

  NHTSA completed tests in July 2015 on model year 2015 Mini 2 Door Hardtop Coopers. One of the vehicles included a contemplated fix – a foam pad on the rear panels – while the other vehicle was no modified from factory settings.

  “The test of the Mini 2 Door Hardtop Cooper with the additional padding and at the higher test weight passed the test,” NHTSA states in the notice.

  However, NHTSA was informed at that time that the BMW had not launched the service campaign it had agreed to the previous year.

  “This was the only vehicle on which the service campaign was performed and thus was not representative of in-use vehicles,” regulators said of the July test.

  Under the new consent order, BMW acknowledges that it failed to recall the noncompliant vehicles in a timely fashion.

  Additional violations discovered in NHTSA’s investigation, include BMW’s failing in multiple recalls to notify owners and dealers of recalls in a timely fashion and to provide required quarterly recall completion reports on time.

  “The requirement to launch recalls and inform consumers in a timely fashion when a safety defect or noncompliance is discovered is fundamental to our system for protecting the traveling public. This is a must-do,” NHTSA Administrator Mark Rosekind said in a statement. “For the second time in three years, BMW has been penalized for failing to meet that obligation. The company must take this opportunity to reform its procedures and its culture to put safety where it belongs: at the top of its priority list.”

  The $40 penalty imposed includes $10 million due in cash, a requirement that the company spend $10 to meet performance obligations, and $20 million in deferred penalties that will be due if the company fails to comply with the order.

  Monday’s penalty comes three years after BMW was ordered to pay $3 million for similar violations.

  
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by Ashlee Kieler via Consumerist

uOnStar Ignores Elderly Man’s Request For Emergency Help Because He’s Not A Subscriberr

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• It can be terrifying when an elderly relative vanishes. One New York man who recently went missing was fortunate to be in a car with an emergency device equipped, and to know how to reach help — but the help then chose not to help him at all, leaving his family mystified about the response.

  An 89-year-old man in upstate New York ended up driving away from home and becoming lost, local channel WHAM reports. He did not have a cell phone, but the car he was driving was equipped with OnStar. He pushed the OnStar button, seeking help, and was rebuffed.

  “They told him there was nothing they could do because he didn’t have a subscription,” the man’s son-in-law told WHAM. OnStar refused to let the man use the service either to call home or to call for emergency assistance.

  Eventually, sheriff’s deputies found the elderly gentleman, unharmed, and were able to return him to his family. But the family are still upset that the GM-owned service couldn’t even be bothered to call 911.

  “They could definitely make a 911 call. There is no excuse – it’s unacceptable,” said the son-in-law.

  When WHAM reached out to OnStar, the company apologized for experience but said that if you’re not an active subscriber, their computers cannot locate your car. In that event, they said, they call the authorities. However, they were unsure whether this emergency call was ever passed along to police or not.

  Family says OnStar ignores 89-year-old’s emergency call [WHAM-13]

  
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by Kate Cox via Consumerist

uRetailers Struggling With In-Store Pickup This Holiday Seasonr

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  Ordering an item online and picking it up at the local outlet of a chain retailer is a great advance in e-commerce, but it seems more convenient than it is. Even when everything is working smoothly, it doesn’t actually save shoppers any time. The service hasn’t been operating smoothly at many retailers this holiday season, though: is it doomed to end up in the trash bin of business ideas that seemed like a good idea at the time?

  The Washington Post shared the story of a Kmart customer who showed up at the store when she received an e-mail that her order was ready, then had to wait around for an hour and a half for the store to actually get her order ready. That’s an extreme example, but shouldn’t be happening.

  Yet it is. A study looking at online orders on Cyber Monday showed that 60% of the transactions had problems. StellaService, a company that tests and reports on customer service, found that 25% of these transactions across the whole holiday season had problems.

  Retailers are even struggling with the question of what they should call the service: “in-store pickup” or “store pickup” are shot but don’t make the part where the item was ordered online clear. We’ve seen “click and collect,” “click and mortar,” and “bricks and clicks” used in industry publications, and they all make us cringe.

  Customers have come to expect profit-gobbling free shipping, and collecting their item from a store is a reasonable alternative, especially when in a hurry.

  Buy online, pick up in store. Simple, right? Not this Christmas. [Washington Post]

  
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by Laura Northrup via Consumerist

uBeware: Delivery Scams Are The Grinch Of The Holiday Seasonr

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  With just days remaining before Christmas, you might be impatiently waiting for a few last deliveries to show up at your door. While those deliveries might be a sight for sore eyes, there’s another – of the scammy kind – that you should be on the look out for. 

  Our colleagues down the hall at Consumer Reports warn readers that not everyone is so giving during the holiday season. In fact, it’s the perfect time for scammy McScammsters to rear their ne’er-do-well heads.

  One scheme that tends to materialize around the holidays involves the one person most people like to see: the delivery man.

  The basic scam works like this: your phone rings with the notification that a delivery is on its way to your home. Before the supposed driver can hand over the “gift,” he needs a small “verification fee” payable by credit or debit card.

  This is where things turn from holiday cheer to scam: the card reader used for verification includes a skimmer, a device often used on ATMs, gas pumps, and other readers to collect card numbers, PIN and/or security codes.

  Fraudsters then use the info gleaned from the device to create duplicates of your card to make unauthorized purchases or steal your identity.

  While CR warns that there are several variations of this scam — you may receive a notice of attempted delivery beforehand or you might receive a bogus email from UPS, USPS or FedEx — there are several ways you can protect yourself:

  • Be suspicious of a package from an unrecognized delivery service. Always ask for their physical address and check them out with the Better Business Bureau.

  • Do not give your credit or debit card to someone at your door. Although it’s acceptable to ask for identification when alcohol is being delivered, you should not be required to pay a fee to receive a gift.

  • Read notices very carefully, especially unsolicited emails. Scams often include poor grammar, urgent requests, unfamiliar domain names and website addresses, and generic greetings.

  Beware of Delivery Scams During the Holidays [Consumer Reports]

  
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by Ashlee Kieler via Consumerist

uFederal Regulators Still Objecting To Marriage Of Staples And Office Depotr

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  Earlier this month, the Federal Trade Commission went to court in an effort to block the pending merger of office-supply mega chains Staples and Office Depot, saying that it would result in too little competition in the market for supplies being sold to businesses. Since then, Staples has tried to revise the deal to make it more palatable, but to no avail.

  Staples revealed this morning that its revised plan, which would have involved divesting up to $1.25 billion of commercial contracts, was rejected by the FTC and that the regulator did not reply with a counteroffer.

  “The company is still willing to continue negotiations with the FTC to reach a settlement that addresses FTC concerns,” reads a statement from Staples.

  At the core of the FTC’s concerns about the $6.3 billion merger is the effect it would have on the market for large businesses to purchase necessary office supplies. Because Staples – the nation’s largest seller of office products and services – and Office Depot are each other’s closest competitors in this arena, the agency believes that the proposed merger would “eliminate beneficial competition that large companies rely on to reduce the costs of office supplies.”

  This is the second time that Staples and Office Depot have tried to merge. Back in 1997, when people still went to bricks-and-mortar stores to make most purchases, the FTC successfully sued to block the marriage from getting to the altar.

  
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by Chris Morran via Consumerist

uMartin Shkreli Terminated From Another CEO Gig Following Fraud Chargesr

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  Things continue to unravel for Martin Shkreli, best known as the guy whose company bought the rights to a previously affordable, life-saving generic drug, then increased its price by 5,400% overnight. After being arrested last week in an unrelated securities-fraud investigation, the “pharma bro” has lost his spanking-new job as CEO of KaloBios Pharmaceuticals. 

  Shkreli’s termination from San Francisco-based KaloBios, which has a current focus on developing treatments for cancer patients, comes just a month after he was appointed to the company’s top seat. Shkreli has also resigned his seat on the KaloBios board.

  In November, Shkreli acquired 70% of KaloBios after he and a group of investors committed to an equity investment of at least $3 million, as well as a commitment of $10 million toward an equity financing facility, the company said at the time.

  On Monday, KaloBios said that Tony Chase, who joined the board at the same time as Shkreli, resigned from his position as a member of the board of directors. The company, which said the termination was effective Dec. 17, did not name an interim leader.

  Shkreli is best known as the guy whose other company, Turing Pharmaceuticals, bought the rights to Daraprim. The drug, an anti-parasitic used to treat malaria and toxoplasmosis, had long been available as a generic for only around $1 per pill. A recent acquisition of the product resulted in a rate hike to $13.50/pill, but immediately after Turing purchased the rights to Daraprim, the per-pill price soared to $750.

  Shkreli now faces charges related to his time running a hedge fund and working at a company called Retrophin.

  On Thursday, he was charged with illegally taking stock from Retrophin, a company he started in 2011, and using it to pay off debts from unrelated business dealings. He pleaded not guilty to the charges of securities fraud and was released on $5 million bail.

  A day later, Turing announced that Shkreli had resigned from his post at that company. Chairman Ron Tilles will fill the role of interim chief. The New York Times pointed out at the time that Tilles was a founder and worked in business development at Retrophin.

  [via Business Insider]

  
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by Ashlee Kieler via Consumerist