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Drug Companies Promise More Data Transparency

July 24, 2013 by Leave a Comment

Representatives of the world’s biggest pharmaceutical companies pledged on Wednesday to release detailed data about their drugs to outside researchers, a move that was applauded by some but also seen as an effort to head off more extensive disclosure requirements that are under review in Europe.

The announcement, made jointly by the two major pharmaceutical trade groups in the United States and Europe, signals a shift for the industry, which in the past has resisted calls to systematically share its data. The proposal was unanimously approved by member companies and is to take effect on Jan. 1. It would apply to all new drugs and all new uses for existing drugs, whether approved in the United States or the European Union.

“Quite frankly, we recognize that there are a lot of skeptics, but this is the right thing to do and the right time to do it,” said John J. Castellani, chief executive of the Pharmaceutical Research and Manufacturers of America, also known as PhRMA, which developed the guidelines with its overseas counterpart, the European Federation of Pharmaceutical Industries and Associations. Members of the two groups collectively represent about 80 percent of the world’s pharmaceutical research, Mr. Castellani said.

“What they are doing would have been thought to be inconceivable even a short time ago,” said Dr. Harlan M. Krumholz, a cardiologist at Yale who recently oversaw an outside review of a treatment by the device maker Medtronic. “If these companies truly fulfill these promises, then they will have made an important contribution to science and the common good.” But he said their efforts would need to be monitored.

Proponents say doctors and patients need independent information — not just that provided by manufacturers — about the risks and benefits of drugs.

But as recently as February, PhRMA issued a statement criticizing proponents of data sharing, saying that releasing what’s known as “patient-level” clinical data would be irresponsible and encourage second-guessing of regulatory agencies, “which would be disastrous for patients.” Both industry groups have opposed a plan by the European Medicines Agency, which oversees approvals in Europe, to make trial data public whenever a drug is approved. A similar effort to require such data disclosure is under way in the European Parliament. On Monday, the British newspaper The Guardian reported on a leaked e-mail that detailed plans by the two trade groups to enlist the help of patient groups to try to kill the efforts in Europe.

Mr. Castellani said the plan released Wednesday should be seen as an alternative to the proposals being considered in Europe, which would have fewer restrictions on the data. Drug makers have raised concerns that patient privacy could be compromised if the data were not properly redacted, and that competitors could mine the documents to gain an advantage. Under the industry plan, companies would set up outside panels to consider requests from “qualified” researchers for a range of data and dossiers that drug companies keep on their drugs. They would also have to provide plans for how they planned to use the data.

Some researchers questioned whether the companies’ review boards would be truly independent, and bristled at what they described as restrictive requirements. But Mr. Castellani said such provisions were necessary. “Putting this out is what we think is a responsible way to meet the researchers’ needs,” he said.

Article source: http://www.nytimes.com/2013/07/25/business/drug-companies-promise-more-data-transparency.html?partner=rss&emc=rss

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Digital Domain: Rewriting the Law on Automated Cellphone Calls

November 13, 2011 by Leave a Comment

Currently, cellphone users are protected from these “robocalls” if they haven’t consented to receive them, but some industry groups are pushing for a clearer path to making those calls.

Since 1991, federal law has protected cellphones from the reach of two kinds of automated calling equipment. One blasts out prerecorded messages to thousands of numbers simultaneously. The other dials many numbers in quick succession, and, if a human answers, signals a customer service representative to come on the line (a telltale moment of dead air signals one of these calls).

Telemarketers cannot make prerecorded calls to either residential landlines or cellphones, unless the recipient has provided express consent or has a business relationship with the caller. For commercial calls that do not involve an explicit sales pitch, the law extends special protection to cellphones: automated equipment cannot be used unless the recipient has provided consent.

“Consent” is not hard to secure. Current law assumes that it is given by the act of providing one’s phone number, even if it was just for a one-time home delivery or was mentioned in reply to a clerk’s spoken question. This allows automated cellphone calls that may not be especially welcome, like a “customer satisfaction” survey administered entirely by robo-software, or robo-messages about an overdue payment.

The Federal Communications Commission has been working on a draft of a stricter rule defining consent. Businesses might be required to secure the customer’s consent in writing or from a box clicked online if automatic calling equipment will be used to call the customer’s cellphone in the future.

The American Bankers Association, the Association of Credit and Collection Professionals and other trade groups want to prevent the F.C.C. from strengthening the consent requirement. They are backing a bill in the House, H.R. 3035, that they say would clarify issues of consent surrounding automated calls.

The lobbyists try to argue that the protections extended to cellphones in 1991 were necessary only because the per-minute cost of receiving calls was high. Those costs have fallen greatly since then — so, they argue, there is no need to continue to treat cellphones differently.

It’s not quite that simple, however. For someone with a flat-rate wireless plan, receiving an unwanted robocall does not incur a cost measured by the minute. But as more consumers use their phones less for actual calls and opt for prepaid plans, there’s a visible cost for every minute of use. Separately, there is the harder-to-calculate cost of having one’s personal space invaded by a robocaller that one never wished to summon.

The bill is opposed by the National Association of Consumer Advocates, the Consumer Federation of America, Americans for Financial Reform, Consumer Watchdog, the U.S. Public Interest Research Group and other consumer advocates.

Currently if consumers would like to receive robocalls on their cellphones, they can give their consent, without need of a new law.

Brad Herrmann, president of Call-Em-All, a company in Frisco, Tex., near Dallas, said: “I’ve seen other companies in the industry say, ‘We currently can’t send informational calls to cellphones.’ I disagree — we do it every day. The current law is clear.”

Call-Em-All provides automated voice and text messages; schools are among its primary clients. The company is able to notify all parents of a snow day, for example, to whatever number they give to the school. This sort of service is not what comes to mind, however, when Mr. Herrmann tells people that he’s in the “automated calls” business. “They think two things: telemarketing or political calls,” he says.

CHURCHES, P.T.A.’s, sports leagues, clubs and associations also use Call-Em-All. Mr. Herrmann says his company, founded in 2005, makes six million automated calls a month.

A robocall to a cellphone about a scheduled softball game that has just been rained out is welcome. A robocall to the same cellphone from a debt collector may not be. One sees why some businesses would like to keep the bar defining consent as low as possible. If they mishandle consent, they could face costly legal exposure.

Sallie Mae, the giant lender to college students, faced a class-action lawsuit last year brought by plaintiffs who claimed that from 2005 to 2010 they had received robocalls to their cellphone numbers without prior express consent. The lender has offered to settle for $19.5 million; the court has not made a final ruling. (A Sallie Mae spokeswoman, Patricia Nash Christel, said, “We have denied vigorously all claims asserted against us and cannot comment further on pending litigation.”)

Cellphones are an immeasurable convenience. But the fact that the phones go wherever we go means that unwanted calls of any kind feel far more intrusive than calls that came in to the home number (for those who remember home numbers). The banks’ last nifty idea for consumers was a monthly charge for debit cards. Their fight to block stronger protection of our cellphone numbers is just as consumer-friendly.

Article source: http://feeds.nytimes.com/click.phdo?i=3223e3f553a675d61ac80d01358e2dd4

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F.A.A. Impasse That Hit 4,000 Ends, for Now

August 5, 2011 by Leave a Comment

The agreement signals an end, at least for a few weeks, to a standoff over policy issues that had left 4,000 agency employees out of work, idled tens of thousands of workers at hundreds of airport construction projects and cost the federal government more than $350 million in lost taxes on airline tickets.

Congressional officials said the deal arranges rubber-stamp passage by the Senate on Friday of a bill that was approved by the House last month, extending the aviation agency’s operations through Sept. 16.

Only a few senators need to be present when the Senate convenes at 10 a.m., and if no one objects to the request for unanimous consent to pass the House bill, the impasse will officially be over.

“This agreement does not resolve the important differences that still remain,” Mr. Reid said in a statement. “But I believe we should keep Americans working while Congress settles its differences, and this agreement will do exactly that.” The agreement, in the wake of a nasty and protracted battle over the debt ceiling, was worked out as both the White House and Congress were beginning to feel pressure from voters who said they have grown tired of political fights that hurt working Americans and the economy.

Official Washington has been peppered in recent days by appeals from labor unions employing furloughed F.A.A. employees and construction workers and letters from trade groups representing airport executives and business groups.

Together, they expressed outrage that Congress left this week on a five-week vacation without resolving the F.A.A. issue, letting $30 million a day in airline ticket and fuel taxes go uncollected because of a dispute over $16.5 million in annual cuts to rural air service.

“This shutdown is putting thousands of critical employees out of work,” a coalition of labor unions said in a statement Thursday, before the deal was reached. “Every day this impasse continues is another day that major airport projects are delayed and work is stopped” on upgrades of airport safety and aviation navigation systems.

Mr. Obama said in a statement that he was “pleased that leaders in Congress are working together” to put tens of thousands of Americans back to work. “We can’t afford to let politics in Washington hamper our recovery, so this is an important step forward,” he said.

Senate Democrats had previously refused to pass the House bill because it contained cuts in the Essential Air Service, a subsidy program that helps to pay for commercial airline service to rural airports.

The breakthrough came on Thursday when the transportation secretary, Ray LaHood, told Congressional leaders that he has the authority to issue waivers for the communities affected by the cuts in rural air service contained in the House bill. The White House had been coordinating discussions for days involving Mr. LaHood, House Speaker John A. Boehner, Mr. Reid and others.

Congressional officials said Mr. LaHood had indicated that he would review the affected rural communities for waivers that would postpone the cuts, but added that he had not promised any specific action.

In a statement, Mr. LaHood said: “This is a tremendous victory for American workers everywhere. From construction workers to our F.A.A. employees, they will have the security of knowing they are going to go back to work and get a paycheck — and that’s what we’ve been fighting for. We have the best aviation system in the world and we intend to keep it that way.”

The agreement does not address differences over labor issues that Senate Democrats said were the real reason that Republicans were trying to press for the cuts to rural air service. Democrats had embraced some of those changes in their own long-term F.A.A. reauthorization bill, which was passed earlier this year by the Senate.

The House also passed a long-term F.A.A. bill that included a measure to repeal a rule of the National Mediation Board, which oversees union and labor issues in the airline and railroad industries. The new rule, which passed after President Obama appointed two of the board’s three members, reversed a 76-year-old rule and made it easier for unions to win a representation election. Under the old rule, workers who did not vote were counted as “no” votes; under the new rule, only those casting ballots were counted.

Andrew Pollack contributed reporting from Los Angeles.

Article source: http://feeds.nytimes.com/click.phdo?i=ce8cbbfff5108a0c92d02b18cf51d2a7

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Fed Caps Debit Card Fees for Merchants

June 30, 2011 by Leave a Comment

The cap is a defeat for banks generally, although the news was not as bad as banks expected. The limits are significantly higher than the initially proposed cap of 12 cents a transaction laid out by the Federal Reserve in December. Banks currently charge merchants an average of 44 cents for a debit card transaction.

The rules were approved on a 4-to-1 vote by the Fed’s Board of Governors.

The new limits include a transaction fee of 21 cents plus an assessment of 5 basis points — 0.05 percent of the transaction amount — for fraud reduction costs, an element that could raise the overall fee by a penny or two on average. The rules would go into effect on Oct. 21, and the Fed is asking for public comment on the fraud portion of the fee cap.

The fee cap is a result of the Dodd-Frank financial regulation act, which was signed into law last July. The law required the Federal Reserve to determine whether the fees charged to process debit card transactions were “reasonable and proportional to the cost incurred” by the bank that issued the cards.

The law allowed, but did not require, the Fed to make an allowance in its fee cap for the cost of preventing fraud, which banks say is a substantial expense. Under the new law, the revamped fees are scheduled to take effect on July 21, the first anniversary of the signing of the Dodd-Frank Act into law.

In December, the Fed proposed a rule that that would cut the allowable “swipe” fee to an average of 12 cents a transaction from an average of 44 cents in 2009, when total interchange fees on debit and prepaid cards reached $16.2 billion, according to the Federal Reserve. According to merchant trade groups, retailers paid $20.5 billion in fees last year to accept debit cards, including processing fees.

Those fees rose significantly during the 2000s, the Federal Reserve found. In the early 1990s, when debit cards were first beginning to expand in popularity, card networks and banks often compensated merchants for the cost of installing terminals that allowed them to accept debit cards at the point of sale.

The direction of fees began to reverse in the mid-1990s, however, with merchants who accepted cards paying the card networks for processing.

Merchants asserted that banks and the major credit card networks steadily raised the fees they charged even as improvements in technology and economies of scale meant that the fees should be falling. And they charged that the two major card networks, Visa and MasterCard, unfairly controlled prices and stifled competition.

The card companies, in turn, said that along with greater debit card use came greater fraud, which the banks had to pay to police. In addition, they said, the costs reflected constant investments in technology, which gave faster transaction confirmations to consumers.

Card companies also frequently offered perks or rewards to debit card users, which also affected costs.

Debit cards grew faster than any other form of electronic payment over the last decade, increasing to 37.9 billion transactions, according to Federal Reserve research.

Congress exempted banks, credit unions and other debit card issuers with assets of less than $10 billion from the cap on debit fees. But officials from the Federal Reserve and the Federal Deposit Insurance Corporation raised doubts earlier this year that regulators could effectively require large banks to charge a lower fee and still allow small banks to charge a higher fee.

Ben S. Bernanke, the Fed chairman, told members of Congress that basic economics precluded such an arrangement — that retailers would naturally favor cards that resulted in them paying lower fees, leaving smaller banks to lose business despite the exemption from the fee cap.

Credit unions and community banks argued strongly against the fee caps, saying that a reduction in those fees might cause them to have to eliminate debit cards or to charge customers higher fees for checking accounts and other services. Large banks, too, said consumers would pay for any reduction in their revenue from debit fees, and some institutions said they might set limits on debit card use.

The debit card rules were the subject of a furious lobbying battle on Capitol Hill and at the Federal Reserve. A bill to delay the rules failed in the Senate earlier this month, garnering 54 votes but falling short of the 60-vote majority required for passage.

Article source: http://feeds.nytimes.com/click.phdo?i=59fd9ab940fc6f377bd60d6f8e9a9564

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Key E.U. Members Resist Letting Some Liquids Onto Airplanes

April 18, 2011 by Leave a Comment

PARIS — With just two weeks remaining before the European Union is due to partly lift a nearly five-year ban on liquids in air passenger hand luggage, several member states representing a significant share of the region’s air traffic have refused to comply with an April 29 deadline, making the change effectively meaningless for millions of travelers for at least several months, according to aviation industry officials.

On Thursday, Britain announced that it would defer easing the restrictions until October, citing a “continuing high threat” at its airports, which include Heathrow, the busiest hub in Europe. The move follows formal notifications in recent weeks by France and Italy that they would ignore the target date, which was set by the European Commission two years ago.

Under the new regime, it was expected that passengers transiting through an E.U. airport from a third country would be allowed to carry liquids, aerosols and gels purchased either at an airport duty-free shop or aboard a non-E.U. airline, provided they were sealed within tamperproof bags and screened before boarding by specialized scanners. But trade groups representing duty-free vendors in Europe and Asia said Friday that they were now urging their members to plan, for now, on maintaining the status quo on sales to Europe-bound passengers.

“It is clear that as things stand, many airports in Europe will not be able to lift the restrictions as scheduled,” the European Travel Retail Council, which represents more than 500 travel retailers, said. “We cannot afford our customers to have products confiscated that are bought in good faith.”

E.U. and industry officials said a handful of other countries, including Slovenia and Bulgaria, had also indicated they would not be complying with the change on April 29, while many other members of the 27-nation bloc had yet to declare their plans. So far, Germany, Denmark and Sweden have formally confirmed their readiness to ease the restrictions at the end of the month, said the officials, who asked not to be identified because of the political sensitivity of the situation.

The European Union, the United States and many other places first introduced the restrictions — which allow liquids only in amounts below 100 milliliters, or about 3 ounces — after the British authorities uncovered a plot in August 2006 to bomb U.S.-bound passenger planes using liquid explosives.

Responding to popular frustration with a policy that has forced passengers to jettison drink containers, toothpaste and even jars of marmalade before boarding planes, the E.U. transport commissioner, Siim Kallas, originally touted the phased-in easing as a way to harmonize and simplify airport security screening across Europe.

Aviation industry officials say they share Mr. Kallas’s goal of lifting the restrictions but have criticized the incremental approach as too unwieldy. Airport groups, meanwhile, have warned that current liquid-explosive detection technology is still too unreliable, potentially undermining passenger safety. Many have quietly urged Mr. Kallas to keep the full ban in place until 2013, when Brussels has vowed to eliminate all cabin restrictions on such goods.

One E.U. official involved in the discussions acknowledged that the split among member states “means that we don’t have as clear a position as had been initially envisioned.” But he confirmed the bloc’s commitment “absolutely to proceed with this small but important step toward a full lifting of the ban in 2013.”

Brian Simpson, a Socialist member of the European Parliament from Britain who heads its Transport and Tourism Committee, said he was disappointed that governments, including his own, were deferring what he described as an “essential step towards the removal of the entire ban in 2013.”

He argued that airports’ resistance to the plan was driven mainly by reluctance to invest in the new screening technology.

“This is not a question of security,” Mr. Simpson said.

Airport groups have not made a formal estimate of the number of transfer passengers who might be affected by the new regulation. But industry data show that as many as half of all transfer passengers at the region’s major hub airports are traveling to and from countries outside the European Union.

At Schiphol Amsterdam Airport, for example, 10 million passengers a year — more than 27,000 a day — are transiting from one non-E.U. country to another. At Air France’s main terminal at Charles de Gaulle Airport outside Paris, 10,000 passengers depart each day who began their journeys outside the European Union.

The commission plans to publish a leaflet on its Web site on April 29 that will aim to provide passengers with the latest information, an E.U. official said.

Airlines said they were worried that an inconsistency across European airports was likely to anger and frustrate travelers trying to make sense of the change.

“We are concerned this will cause disruption,” said Victoria Moores, a spokeswoman for the Association of European Airlines in Brussels. “It looks like there will be plenty of exceptions, which just makes a complicated situation much more complicated.”

Having grown accustomed to keeping liquids and gels out of their carry-ons, Ms. Moores said, “people just want to know what the new script is.” If it’s unclear, she said, “they’ll stick with what they’ve been doing to be on the safe side.”

Article source: http://feeds.nytimes.com/click.phdo?i=d0c17fdff124b35cf65ed47d8d9613c9

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Mortgages: Broker Fee Rules Take Effect

April 17, 2011 by Leave a Comment

Regulators and consumer advocates say borrowers are bound to benefit. Broker trade groups say their industry will shrivel and consumer costs will go up.

Mortgage brokers are middlemen who work with multiple lenders to arrange home loans for customers. They say they add value by helping borrowers find the best deal; their detractors say they add costs that have been hidden in complex fees.

The business has contracted significantly in the last five years. In 2005, during the real estate boom, brokers accounted for 31 percent of mortgages originated, according to Inside Mortgage Finance, a trade publication. Last year it was just 11 percent, and the market was only half as big.

Brokers used to be compensated by a mix of borrower-paid origination fees and lender-paid fees. The most controversial was a “yield spread premium,” paid by lenders when a broker placed a borrower in a loan that charged higher interest than other loans. The justification was that higher rates allowed lower upfront closing costs. The criticism was that the premiums were an incentive to push expensive loans and that the system contributed to a flood of risky loans and thus to the financial crisis.

In response, the Federal Reserve put out rules that prohibit loan originators from being paid by both the borrower and lender on the same deal, and also barring commissions based on anything other than loan size. The rules were set to take effect April 1; two trade groups sued, delaying enactment a few days before a federal appeals court allowed it. Both the National Association of Mortgage Brokers and the National Association of Independent Housing Professionals say they will keep pressing their lawsuits.

On the front line, the problem is that there has been “no clear guidance” on exactly how to arrange commission structures for employees who originate loans, said Melissa Cohn, the president of the Manhattan Mortgage Company, a loan brokerage firm.

“To be honest with you,” she said, “in some cases it’s going to create higher-priced mortgages.” Although the spirit of the law is to protect borrowers, she added, “the reality of it is it’s just going to cause more confusion.”

Mike Anderson, the director of the National Association of Mortgage Brokers, speaking just two days after the rules went into effect, said: “It’s already happening. Rates have already gone up; fees have gone up.” Mr. Anderson, who is also a broker in New Orleans, cited situations in which brokers could no longer cut fees to make deals go through, and others in which banks were raising charges. “The rules basically pick the winners and losers,” he said, with the winners being the big banks. “The losers are the small businesses.”

The Facebook page of the National Association of Independent Housing Professionals is full of complaints from what appear to be mortgage brokers saying the rules will hurt their business, and recounting how unnamed lenders have raised prices.

Despite industry opposition, the change is a victory for borrowers, according to representatives of the Center for Responsible Lending, an advocacy group long critical of the yield-spread premium system. Borrowers “should be getting more honest services from the originator they’re working with,” said Kathleen E. Keest, a senior policy counsel, “because that originator is no longer going to have a conflict of interest if they put a borrower in a loan with a higher interest rate or riskier terms.”

“If people were saying that the way things worked, worked well,” she added, “that’s one thing, but it’s very clear the way things worked before didn’t work for anybody. The notion we need to have the same rules is denying what happened. It’s denying that the way the market was working was disastrous for everybody.”

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