The Boston Globe from Boston, Massachusetts • C5

The Boston Globe Business C5 TUESDAY, AUGUST 15, 2017 FedEx-like system targets fake drugs THE BOSTON GLOBE 25 Index of publicly traded companies in Massachusetts Globe 25 index Total market cap: 135 'If a manufacturer determines that a product has been now they can tell FDA and the people that they sold it CONNIE JUNG A senior FDA adviser 10 High: 131. 17 -5 125 115 DRUGS Continued from Page CI Lipitor the top-selling drug in pharma history. The US government is cracking down on counterfeit drugs in the pipelines of drug makers, packaging companies, distributors, and pharmacies that deliver medicine to consumers known as the drug supply chain. In 2013, Congress passed the Drug Supply Chain and Security Act, also known as "track and trace." The law requires companies to label each package of prescription medicine with a unique serial number and track that package's movement at every stage in effect, a FedEx-style approach for drugs. The law is being implemented in three phases over 10 years.

In the first phase, companies must show the FDA they can track large batches of medicine, known as lots, and maintain electronic records of these movements. Lot-level tracing has been in place since 2015. Next, each drug package including bottles, inhalers, and needles must be labeled with a unique serial barcode, akin to those on the items at your local grocery store. This phase begins in November, but the FDA has delayed enforcement until 2018. Jung says that the grace period is due to industry feedback that generating these barcodes, stamping them onto each package, and storing the data will take time.

The third and final phase, to take effect in 2023, is for companies to track each package of medicine from when it's made until it reaches the pharmacy. This level of tracking should make it easier to weed out counterfeit drugs. "If a manufacturer determines that a product has been counterfeited, now they can tell FDA and the people that they sold it to," Jung said. "Once you have a unique number, you'll identify the counterfeits a lot quicker." Getting into compliance with track and trace will require major investments by members of the drug-supply chain. Eli Lilly has already poured over $110 million into safeguarding medicines such as its erectile dysfunction pill Cialis a popular target for counterfeiters.

And Dave Sternasty, vice president of corporate engineering at Lilly, says the company is on track to meet the upcoming deadline for serial barcodes. "We've put a lot of effort into being able to serialize the packages," Sternasty said. "It's really important to us that our patients get the medicines that they're counting on." In some cases, companies don't already have the know-how to meet the new requirements. That's where third parties like TraceLink come in. TraceLink offers cloud-computing software to help companies create unique serial codes and relay product information from one member of the supply chain to the next.

The company works with over 600 clients in more than 20 countries. "In working with a company, we're not just going to work with your systems," said Brian Dale-iden, cofounder of TraceLink. "We're going to work with you to identify every connection between you and every network partner." The FDA has regularly held public meetings for companies to dis cuss the upcoming track and trace requirements. And it's creating a pilot program for companies to test different solutions. The program is open for public comment on what the focus of the pilot projects should be and has gotten input from a wide range of stakeholders, including Novo Nordisk, TraceLink, and the American Pharmacists Association.

The United States isn't the only country cracking down on counterfeit drugs. China, Turkey, Brazil, Argentina, and the European Union all have new regulations though details vary from country to country. "The biggest challenge is the global harmonization of standards," said Lilly's Sternasty. "We are working with a number of different countries and regulatory groups each have their own requirements and specific timing." There has been a growing push in the United States for access to drugs abroad. Consumers and advocacy groups cite the need to reduce costs and provide patients with life-saving medications some of which are not yet approved in the United States.

But critics, including the FDA, point to safety concerns and say that other countries' efforts to tighten their supply chains won't eliminate these concerns. 'Tor counterfeits, you don't know who made them. You don't know how they were made. Someone may claim yes, these are made in a certain country. But you don't really know," said Jung of the FDA.

"As a consumer, I would think you would have some hesitancy if you didn't have control." Jonathan Wosen can be reached at jonathan.wosen statnews. com. 15 22 29 5 12 19 26 3 10 17 24 31 7 14 Yesterday aytd Market Price Chg chg cap (bil.) General Electric Co (GE) 25.36 0.16 0.6 219.6 Thermo Fisher Sci(TMO) 174.03 0.80 0.5 69.6 Biogen(BIIB) 286.05 2.37 0.8 60.5 American Tower Corp. (AMT) 139.97 3.29 2.4 60.1 Raytheon(RTN) 180.34 0.99 0.6 52.3 TJXCOS.CTJX) 69.62 44.8 Vertex PharmaCVRTX) 154.49 0.71 0.5 38.9 Boston Scientific (BSX) 26.68 0.27 1.0 36.6 State Street Corp. (STT) 93.52 1.44 1.6 35.0 Analog Devices (ADD 79.90 1.86 2.4 29.3 Eversource Energy(ES) 62.17 0.31 0.5 19.7 Skyworks Solutions (SWKS) 105.47 2.29 2.2 19.4 Boston Properties (BXP) 122.51 2.46 2.0 18.9 Waters Corp.

(WAT) 179.76 2.73 1.5 14.3 Hologic(HOLX) 38.44 0.24 0.6 10.8 Affiliated Managers (AMG) 178.39 3.16 1.8 10.0 Iron Mountain(IRM) 37.63 0.50 1.3 9.9 103.87 2.35 2.3 9.0 Akamai Tech (AKAM) 46.82 0.45 1.0 8.0 PerkinElmer(PKI) 64.00 0.07 0.1 7.1 TeradyneCTER) 34.36 0.88 2.6 6.8 Staples(SPLS) 10.21 0.07 0.7 6.7 PTC(PTC) 53.42 0.08 0.2 6.2 Tesaro(TSRO) 113.25 1.40 1.3 6.1 TripAdvisor(TRIP) 41.48 5.8 Airport's cabbies losing fares to Uber Markets Stocks regain some lost ground US stocks rallied Monday as technology companies and banks helped regain a lot of the ground lost last week. Almost 90 percent of the Standard Poor's 500 finished higher. Tech stocks outpaced the rest of the market following a strong report on Japan's economy. Last week, rising tensions between the United States and North Korea sent stocks to some of their biggest losses in 2017. That eased Monday after officials said conflict is not imminent.

Among tech companies, Apple added 1.5 percent, as did Microsoft. After two days of losses, Nvidia jumped 8 percent as chip makers made outsize gains. Bond prices turned lower. The yield on the 10-year Treasury note rose to 2.22 percent from 2. 19 percent.

That helped banks; higher bond yields mean higher interest rates and greater profits on mortgages and other loans. Bank of America climbed 2.3 percent, while JPMorgan Chase gained 1 .2 percent. Target is buying a logistics company, Grand Junction, to help it offer same-day deliveries to in-store shoppers. Target stock rose 1.4 percent. Amazon.com rose 1.6 percent.

VF Corp said it will buy work clothes maker Williamson-Dickie; it rose 3.1 percent. DOW JONES industrial average JOHN TLUMACKIGLOBE STAFFFILE 2012 LOGAN Continued from Page CI barred from picking people up at the airport until earlier this year, after the state began checking drivers' backgrounds. Previously, only Uber drivers who were licensed as livery drivers could be summoned by passengers using an app. Yet livery drivers are also providing fewer rides since operations like Uber and Lyft began picking up at Logan, Glynn said, though he did not provide exact figures. But the numbers don't tell a complete story, he said, because many licensed livery drivers who also drive for Uber are included in Uber statistics.

Scott Solombrino, a limousine executive and industry advocate, said that the livery business has been mostly unaffected by ride-hail services. However, he said, the addition of Uber and Lyft has led to increased congestion that is "really causing trauma at the airport." For taxi drivers, the arrival in February of ride-hail drivers at Logan was a death knell: The airport was the one last place where they were insulated from such competition. Glynn said many taxi drivers had flocked to Logan because they struggled to find fares on the streets of Boston. Now, the nunber of drivers at the airport plus the lower demand Many taxi drivers considered the arrival of Uber and Lyft at Logan as a death knell. The airport had been the one place where they were protected against competition by app -based ride-hailing operations.

23,000 and ride-hail companies have combined for more than 366,000 monthly pickups, compared to an average of about 289,000 during the first half of 2016. Ridership on Logan Express shuttles, buses that carry people between the airport and suburban parking lots, is also up, by about 5 percent this year. But on the MBTA, Blue Line ridership at the airport was down almost 1 percent compared to 2016, and ridership on the Silver Line at Logan was down 2.7 percent earlier this year, according to Massport. Glynn said that more passengers may be opting for hired rides because of Massachusetts Turnpike and Sumner Tunnel highway work. Adam Vaccaro can be reached at adam.vaccaroglobe.com.

Follow him on Twitter at adamtvaccaro. means it "takes more time for them to get a trip." "From a passenger perspective, that's a good thing," he said. "If I'm a cab driver, I liked last year's situation better." In a statement, Uber said it is "proud to offer access to an affordable, reliable transportation option at Logan Airport and will continue to work with Massport to improve the experience for both riders and drivers." Lyft said: "We take a collaborative approach when working with officials at airports and always seek out ways to reduce congestion while creating the best possible experience for drivers and passengers." Allowing ride-hail services at Logan has resulted in a sharp increase in the number of passengers using car services to leave the airport this year. Since February, taxis, limos, 22,000 High: 22,118.42 3.71 Low: 3 21,000 20,000 15 22 29 5 12 19 26 3 10 17 24 31 7 14 Yesterday aytd NASDAQ Composite index 6,700 Bitcoin price surges after deal on software update 6,400 10 High: 6,422.75 Low: 6,100 5,800 5,500 15 22 29 5 12 19 26 3 10 17 24 31 7 14 On Monday afternoon, bitcoin was trading above $4,290, an increase of about 7 percent. Yesterday aytd index 2,600 By Nathaniel Popper NEW YORK TIMES NEW YORK The price of bit-coin has rocketed to new highs after a long battle over the rules of the software was resolved, at least temporarily.

The price of a bitcoin has risen nearly 50 percent since the beginning of the month, raising the total value of all bitcoins to more than $70 billion. On Monday afternoon, bitcoin was trading above $4,290, an increase of about 7 percent. The price of bitcoin, the virtual currency, has been climbing steadily for the past year as investors around the world have shown an interest in the unusual characteristics of its technology, which allows money to be held and moved on a network of computers without any central authority or bank involved. But the latest price increase occurred after the most important backers of the bitcoin network agreed on a long-disputed update to the network's software and rules. As bitcoin has grown more popular, internal factions have been warring over the best way to update the software and allow more transactions to move through the system.

A rule in the original software, released in 2009, limited the number of transactions that could move through the system to about five a second. In the past two years, an outspoken group of bitcoin aficionados wanted to see the currency expand quickly to compete with Visa and PayPal. But that camp faced opposition from the core developers, a few dozen programmers who maintain the basic bitcoin software, generally on a volunteer basis. At the end of July, some of the people who wanted bitcoin to expand quickly broke off and created a rival digital money, known as Bit-coin Cash, that can handle more frequent transactions. That new currency has attracted a small following, and retained a relatively stable value around $300.

Most bitcoin investors and companies, however, have stayed with the original bitcoin network and the core developers who are working on it. The core developers have come up with their own solution to increase the number of transactions running through the system, known as Segregated Witness, or SegWit. While SegWit does not expand the network as quickly as Bitcoin Cash, it makes it easier to build services on top of the bitcoin network, such as the Lightning Network, that will allow for faster transactions. The biggest backers of the network agreed last week to proceed with SegWit, and it is that agreement, on scaling the network, that is the most obvious reason for the recent surge. "Scaling has been the major catalyst for the price rally," said Charles Hayter, founder of data company CryptoCompare.

"The scaling debate has certainly been holding the bitcoin price back." 2,500 10 Last: 2,41 5.84 'rU High: 2,480.91 Low: -5 -10 2,400 2,300 2,200 15 22 29 5 12 19 26 3 10 17 24 31 7 14 Yesterday YTD SOURCE: Bloomberg News.